Datasets:

jinhybr

/

docvqa_donut_1200

like 0

{ "de": "Von wem ist dieses Dokument geschrieben?", "en": "By whom is this document written?", "es": "¿Por quién está escrito este documento?", "fr": "Par qui ce document est-il écrit?", "it": "Da chi è scritto questo documento?" }

[ "Stacey Dixon Calahan" ]

[ "Takeda", "Pharmaceuticals", "U.S.A.,", "Inc.", "Address", ":", "One", "Takeda", "Parkway,", "Deerfield,", "IL", "60015,", "U.S.A", "Tel", ":", "+1-224-554-5586", "E-mail:", "stacey.calahan@takeda.com", "(Copy)", "Kazuyuki", "Kisaka", "Senior", "Director", "IP", "Licensing", "&", "R&D", "Contracts", "Takeda", "Pharmaceutical", "Company", "Limited", "Address:", "1-1,", "Doshomachi", "4-chome,", "Chuo-ku,", "Osaka", "540-8645,", "Japan", "Tel:", "06-6204-2145", "E-mail:", "kazuyuki.kisaka@takeda.com", "In", "addition,", "we", "would", "appreciate", "your", "notifying", "me", "of", "any", "subpoenas", "or", "requests", "for", "information", "you", "may", "receive", "for", "Takeda", "or", "Actos-related", "information.", "Thank", "you", "in", "advance", "for", "your", "cooperation.", "Very", "truly", "yours,", "Stacey", "Dixon", "Calahan", "Assistant", "General", "Counsel,", "Litigation", "Takeda", "Pharmaceuticals", "U.S.A.,", "Inc.", "cc:", "Stacie", "Switzer", "(Legal", "Department,", "Takeda", "Pharmaceuticals", "U.S.A.,", "Inc.)", "cc:", "Kazuyuki", "Kisaka", "(Legal", "Department,", "Takeda", "Pharmaceutical", "Company", "Limited)", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RIM30b6-00001063", "Source:", "https://www.indup5374", "00094ts.ucsf.edu/docs/ksjf0226" ]

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{ "match_score": 1, "matched_text": "Stacey Dixon Calahan", "start": 587, "text": "Stacey Dixon Calahan" }

{ "de": "Wie lautet das erwähnte Datum?", "en": "What is the date mentioned?", "es": "¿Cuál es la fecha mencionada?", "fr": "Quelle est la date mentionnée?", "it": "Qual è la data indicata?" }

[ "January 21, 1999" ]

[ "FROM", "HERETAN", "DEMAS", "FAX05-6204-2943", "19994", "18218", "(*)", "21", "31/21", ":", "28/x56:480:", "941295", "F", "1", "Takeda", "Chemical", "Industries,", "Ltd.", "Takeda", "Product", "Planning", "&", "Management", "Dept.,", "International", "Division", "1-1", "Doshomachi", "4-chome,", "Chuo-Ku,", "Osaka", "541,", "JAPAN", "Tel:", "+81", "6", "(204)", "2852", "Fax:", "+81", "6", "(204)", "2943", "TELEFAX", "MESSAGE", "To:", "E.", "Lilly", "&", "Company", "Date:", "January", "21,", "1999", "Att:", "Mr.", "Larry", "Ellingson", "From:", "Kunio", "Iwatani", "Executive", "Director", "Actos", "Product", "Team", "CC:", "Mr.", "Hamanaka,", "TPA", "Subject:", "Upjohn", "Matter", "Dear", "Mr.", "Ellingson,", "Enclosed", "please", "find", "a", "copy", "of", "Upjohn's", "letter", "to", "US", "FDA", "dated", "January", "7,", "1994.", "In", "the", "letter", "Upjohn", "said", "that", "in", "preliminary", "clinical", "evaluation", "in", "the", "United", "States,", "pioglitazone", "did", "not", "satisfy", "Upjohn's", "internal", "requirement", "for", "reduction", "blood", "glucose;", "therefore,", "the", "considerable", "programs", "required", "for", "development", "of", "pioglitazone", "are", "not", "in", "line", "with", "Upjohn's", "business", "needs.", "-..", "They", "did", "not", "mention", "about", "safety", "of", "pioglitazone.", "After", "Upjohn's", "decision,", "Takeda", "approached", "FDA", "and", "consulted", "whether", "Takeda", "might", "go", "further", "the", "clinical", "development", "works", "on", "pioglitazone.", "Since", "the", "FDA's", "response", "was", "positive", "to", "go", "ahead,", "Takeda", "took", "over", "Upjohn's", "works", "and", "finally", "filed", "NDA", "on", "January", "15,", "1999.", "This", "is", "the", "story", "of", "the", "fact.", "Although", "there", "may", "be", "rumors", "about", "the", "reasons", "of", "Upjohn's", "abandonment", "of", "pioglitazone", "development,", "specially", "from", "the", "viewpoints", "of", "safety", "issues,", "it", "might", "be", "advisable", "for", "us", "to", "keep", "saying", "that", "Upjohn's", "decision", "is", "based", "on", "JAN", "21", "'99", "07:43", "DALY", "19", "06", "6204", "2943", "PAGE", ".", "01", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-CRCARCH-00003000", "Source:", "https://www.indupbodsfoodonts.ucsf.edu/docs/nljf0226" ]

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{ "match_score": 1, "matched_text": "January 21, 1999", "start": 324, "text": "January 21, 1999" }

{ "de": "An wen richtet sich dieses Dokument?", "en": "To whom is this document addressed?", "es": "¿A quién se dirige este documento?", "fr": "À qui s'adresse ce document?", "it": "A chi è indirizzato questo documento?" }

[ "Mr. Larry Ellingson", "Mr. Ellingson" ]

[ "FROM", "HERETAN", "DEMAS", "FAX05-6204-2943", "19994", "18218", "(*)", "21", "31/21", ":", "28/x56:480:", "941295", "F", "1", "Takeda", "Chemical", "Industries,", "Ltd.", "Takeda", "Product", "Planning", "&", "Management", "Dept.,", "International", "Division", "1-1", "Doshomachi", "4-chome,", "Chuo-Ku,", "Osaka", "541,", "JAPAN", "Tel:", "+81", "6", "(204)", "2852", "Fax:", "+81", "6", "(204)", "2943", "TELEFAX", "MESSAGE", "To:", "E.", "Lilly", "&", "Company", "Date:", "January", "21,", "1999", "Att:", "Mr.", "Larry", "Ellingson", "From:", "Kunio", "Iwatani", "Executive", "Director", "Actos", "Product", "Team", "CC:", "Mr.", "Hamanaka,", "TPA", "Subject:", "Upjohn", "Matter", "Dear", "Mr.", "Ellingson,", "Enclosed", "please", "find", "a", "copy", "of", "Upjohn's", "letter", "to", "US", "FDA", "dated", "January", "7,", "1994.", "In", "the", "letter", "Upjohn", "said", "that", "in", "preliminary", "clinical", "evaluation", "in", "the", "United", "States,", "pioglitazone", "did", "not", "satisfy", "Upjohn's", "internal", "requirement", "for", "reduction", "blood", "glucose;", "therefore,", "the", "considerable", "programs", "required", "for", "development", "of", "pioglitazone", "are", "not", "in", "line", "with", "Upjohn's", "business", "needs.", "-..", "They", "did", "not", "mention", "about", "safety", "of", "pioglitazone.", "After", "Upjohn's", "decision,", "Takeda", "approached", "FDA", "and", "consulted", "whether", "Takeda", "might", "go", "further", "the", "clinical", "development", "works", "on", "pioglitazone.", "Since", "the", "FDA's", "response", "was", "positive", "to", "go", "ahead,", "Takeda", "took", "over", "Upjohn's", "works", "and", "finally", "filed", "NDA", "on", "January", "15,", "1999.", "This", "is", "the", "story", "of", "the", "fact.", "Although", "there", "may", "be", "rumors", "about", "the", "reasons", "of", "Upjohn's", "abandonment", "of", "pioglitazone", "development,", "specially", "from", "the", "viewpoints", "of", "safety", "issues,", "it", "might", "be", "advisable", "for", "us", "to", "keep", "saying", "that", "Upjohn's", "decision", "is", "based", "on", "JAN", "21", "'99", "07:43", "DALY", "19", "06", "6204", "2943", "PAGE", ".", "01", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-CRCARCH-00003000", "Source:", "https://www.indupbodsfoodonts.ucsf.edu/docs/nljf0226" ]

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{ "match_score": 1, "matched_text": "Mr. Larry Ellingson", "start": 346, "text": "Mr. Larry Ellingson" }

{ "de": "Zu welcher Abteilung gehört es?", "en": "to which department it belongs to ?", "es": "¿A qué departamento pertenece?", "fr": "A quel service il appartient?", "it": "a quale dipartimento appartiene?" }

[ "DEPARTMENT OF HEALTH AND HUMAN SERVICES", "department of health and human services." ]

[ "DEPARTMENT", "OF", "HEALTH", "AND", "HUMAN", "SERVICES", "Form", "Approved;", "OMB", "No.", "0910-0014", "PUBLIC", "HEALTH", "SERVICE", "Expiration", "Date:", "November", "30,", "2002", "FOOD", "AND", "DRUG", "ADMINISTRATION", "See", "OMB", "Statement", "on", "Reverse.", "INVESTIGATIONAL", "NEW", "DRUG", "APPLICATION", "(IND)", "NOTE:", "No", "drug", "may", "be", "shipped", "or", "clinical", "TITLE", "21,", "CODE", "OF", "FEDERAL", "REGULATIONS", "(CFR)", "PART", "312)", "investigation", "begun", "until", "an", "IND", "for", "that", "investigation", "is", "in", "effect", "(21", "CFR", "312.40)", ".", "NAME", "OF", "SPONSER", "2.", "DATE", "OF", "SUBMISSION", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "11/18/2002", "3.", "ADDRESS", "(Number,", "Street,", "City,", "State", "and", "Zip", "Code)", "4.", "TELEPHONE", "NUMBER", "(Include", "Area", "Code)", "475", "Half", "Day", "Road,", "Suite", "500", "847-383-3739", "Inshire,", "IL", "60069", "5.", "NAME(S)", "OF", "DRUG", "(Include", "all", "eveilable", "names:", "Trade,", "Generic,", "Chemical", "Code)", "6.", "IND", "NUMBER", "(If", "previously", "assigned)", "ACTOSO", "(pioglitazone", "HCI)", "33.729", "7.", "INDICATION(S)", "(Covered", "by", "this", "submission)", "NA", "B.", "PHASE(S)", "OF", "CLINICAL", "INVESTIGATION", "TO", "BE", "CONDUCTED:", "O", "PHASE", "1", "O", "PHASE2", "DPHASE3", "O", "OTHER", "NA", "(Specify)", "9.", "LIST", "NUMBERS", "OF", "ALL", "INVESTIGATIONAL", "NEW", "DRUG", "APPLICATIONS", "(21", "CFR", "Pan", "312),", "NEW", "DRUG", "OR", "ANTIBIOTIC", "APPLICATIONS", "(21", "CFR", "Part", "314).", "DRUG", "MASTER", "FILES", "(21", "CFR", "Part", "314.420),", "AND", "PRODUCT", "LICENSE", "APPLICATIONS", "(21", "CFR", "Part", "601)", "REFERRED", "TO", "IN", "THIS", "APPLICATION.", "N/A", "10.", "IND", "submission", "should", "be", "consecutively", "numbered.", "The", "Initial", "IND", "should", "be", "numbered", "\"Serial", "number:", "000.\"", "The", "next", "submission", "(e.g.,", "amendment,", "report,", "or", "correspondence)", "SERIAL", "NUMBER", "should", "be", "numbered", "\"Serial", "Number:", "001.\"", "Subsequent", "submissions", "should", "be", "numbered", "consecutively", "in", "the", "order", "In", "which", "they", "are", "submitted.", "5", "01", "$1.", "THIS", "SUBMISSION", "CONTAINS", "THE", "FOLLOWING:", "(Check", "all", "that", "apply)", "INITIAL", "INVESTIGATIONAL", "NEW", "DRUG", "APPLICATION", "(IND)", "O", "RESPONSE", "TO", "CLINICAL", "HOLD", "PROTOCOL", "AMENDMENT(S):", "INFORMATION", "AMENDMENT(S)", "IND", "SAFETY", "REPORT(S):", "NEW", "PROTOCOL", "100", "CHEMISTRY/MICROBIOLOGY", "INITIAL", "WRITTEN", "REPORT", "CHANGE", "IN", "PROTOCOL", "PHARMACOLOGY/TOXICOLOGY", "FOLLOW-UP", "TO", "A", "WRITTEN", "REPORT", "NEW", "INVESTIGATOR", "O", "CLINICAL", "RESPONSE", "TO", "FDA", "REQUEST", "FOR", "INFORMATION", "J", "ANNUAL", "REPORT", "O", "GENERAL", "CORRESPONDENCE", "\"REQUEST", "FOR", "REINSTATEMENT", "OF", "IND", "THAT", "IS", "WITHDRAWN.", "INACTIVATED,", "TERMINATED", "OR", "DISCONTINUED", "OTHER", "CHECK", "ONLY", "IF", "APPLICABLE", "JUSTIFICATION", "STATEMENT", "MUST", "BE", "SUBMITTED", "WITH", "APPLICATION", "FOR", "ANY", "CHECKED", "BELOW.", "REFER", "TO", "THE", "CITED", "CFR", "SECTION", "FOR", "FURTHER", "INFORMATION.", "TREATMENT", "IND", "21", "CFR", "312.36(b)", ":", "TREATMENT", "PROTOCOL", "21", "CFR", "312.35(*)", "[", "CHARGE", "REQUEST/NOTIFICATION", "21", "CFR312.7(d)", "FOR", "FDA", "USE", "ONLY", "COR/DBIND/DGD", "RECEIPT", "STAMP", "DOR", "RECEIPT", "STAM", "DIVISION", "ASSIGNMENT:", "IND", "NUMBER", "ASSIGNED:", "FORM", "FDA", "1571", "(9/02)", "PREVIOUS", "EDITION", "IS", "OBSOLETE.", "PAGE", "1", "OF", "2", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-INDNDA-01273549", "Produced", "in", "MDL", "on", "09/1", "1/2012", "Source:", "https://www.induptus/qcooogsts.ucsf.edu/docs/gyjf0226" ]

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{ "match_score": 1, "matched_text": "DEPARTMENT OF HEALTH AND HUMAN SERVICES", "start": 0, "text": "DEPARTMENT OF HEALTH AND HUMAN SERVICES" }

{ "de": "Von wem ist dieses Dokument geschrieben?", "en": "By whom is this document written?", "es": "¿Por quién está escrito este documento?", "fr": "Par qui ce document est-il écrit?", "it": "Da chi è scritto questo documento?" }

[ "Kunio Iwatani" ]

[ "FROM", "HERETAN", "DEMAS", "FAX05-6204-2943", "19994", "18218", "(*)", "21", "31/21", ":", "28/x56:480:", "941295", "F", "1", "Takeda", "Chemical", "Industries,", "Ltd.", "Takeda", "Product", "Planning", "&", "Management", "Dept.,", "International", "Division", "1-1", "Doshomachi", "4-chome,", "Chuo-Ku,", "Osaka", "541,", "JAPAN", "Tel:", "+81", "6", "(204)", "2852", "Fax:", "+81", "6", "(204)", "2943", "TELEFAX", "MESSAGE", "To:", "E.", "Lilly", "&", "Company", "Date:", "January", "21,", "1999", "Att:", "Mr.", "Larry", "Ellingson", "From:", "Kunio", "Iwatani", "Executive", "Director", "Actos", "Product", "Team", "CC:", "Mr.", "Hamanaka,", "TPA", "Subject:", "Upjohn", "Matter", "Dear", "Mr.", "Ellingson,", "Enclosed", "please", "find", "a", "copy", "of", "Upjohn's", "letter", "to", "US", "FDA", "dated", "January", "7,", "1994.", "In", "the", "letter", "Upjohn", "said", "that", "in", "preliminary", "clinical", "evaluation", "in", "the", "United", "States,", "pioglitazone", "did", "not", "satisfy", "Upjohn's", "internal", "requirement", "for", "reduction", "blood", "glucose;", "therefore,", "the", "considerable", "programs", "required", "for", "development", "of", "pioglitazone", "are", "not", "in", "line", "with", "Upjohn's", "business", "needs.", "-..", "They", "did", "not", "mention", "about", "safety", "of", "pioglitazone.", "After", "Upjohn's", "decision,", "Takeda", "approached", "FDA", "and", "consulted", "whether", "Takeda", "might", "go", "further", "the", "clinical", "development", "works", "on", "pioglitazone.", "Since", "the", "FDA's", "response", "was", "positive", "to", "go", "ahead,", "Takeda", "took", "over", "Upjohn's", "works", "and", "finally", "filed", "NDA", "on", "January", "15,", "1999.", "This", "is", "the", "story", "of", "the", "fact.", "Although", "there", "may", "be", "rumors", "about", "the", "reasons", "of", "Upjohn's", "abandonment", "of", "pioglitazone", "development,", "specially", "from", "the", "viewpoints", "of", "safety", "issues,", "it", "might", "be", "advisable", "for", "us", "to", "keep", "saying", "that", "Upjohn's", "decision", "is", "based", "on", "JAN", "21", "'99", "07:43", "DALY", "19", "06", "6204", "2943", "PAGE", ".", "01", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-CRCARCH-00003000", "Source:", "https://www.indupbodsfoodonts.ucsf.edu/docs/nljf0226" ]

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{ "match_score": 1, "matched_text": "Kunio Iwatani", "start": 372, "text": "Kunio Iwatani" }

{ "de": "Wie lautet das Datum der Einreichung?", "en": "what is the date of submission?", "es": "¿Cuál es la fecha de presentación?", "fr": "Quelle est la date de soumission?", "it": "qual è la data di presentazione?" }

[ "11/18/2002" ]

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{ "match_score": 1, "matched_text": "11/18/2002", "start": 495, "text": "11/18/2002" }

{ "de": "was ist die Telefonnummer (inklusive Vorwahl)?", "en": "what is the telephone number (include area code)?", "es": "¿Cuál es el número de teléfono (incluye el código de área)?", "fr": "Quel est le numéro de téléphone (y compris l'indicatif régional)?", "it": "qual è il numero di telefono (incluso il codice di zona)?" }

[ "847-383-3739" ]

[ "DEPARTMENT", "OF", "HEALTH", "AND", "HUMAN", "SERVICES", "Form", "Approved;", "OMB", "No.", "0910-0014", "PUBLIC", "HEALTH", "SERVICE", "Expiration", "Date:", "November", "30,", "2002", "FOOD", "AND", "DRUG", "ADMINISTRATION", "See", "OMB", "Statement", "on", "Reverse.", "INVESTIGATIONAL", "NEW", "DRUG", "APPLICATION", "(IND)", "NOTE:", "No", "drug", "may", "be", "shipped", "or", "clinical", "TITLE", "21,", "CODE", "OF", "FEDERAL", "REGULATIONS", "(CFR)", "PART", "312)", "investigation", "begun", "until", "an", "IND", "for", "that", "investigation", "is", "in", "effect", "(21", "CFR", "312.40)", ".", "NAME", "OF", "SPONSER", "2.", "DATE", "OF", "SUBMISSION", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "11/18/2002", "3.", "ADDRESS", "(Number,", "Street,", "City,", "State", "and", "Zip", "Code)", "4.", "TELEPHONE", "NUMBER", "(Include", "Area", "Code)", "475", "Half", "Day", "Road,", "Suite", "500", "847-383-3739", "Inshire,", "IL", "60069", "5.", "NAME(S)", "OF", "DRUG", "(Include", "all", "eveilable", "names:", "Trade,", "Generic,", "Chemical", "Code)", "6.", "IND", "NUMBER", "(If", "previously", "assigned)", "ACTOSO", "(pioglitazone", "HCI)", "33.729", "7.", "INDICATION(S)", "(Covered", "by", "this", "submission)", "NA", "B.", "PHASE(S)", "OF", "CLINICAL", "INVESTIGATION", "TO", "BE", "CONDUCTED:", "O", "PHASE", "1", "O", "PHASE2", "DPHASE3", "O", "OTHER", "NA", "(Specify)", "9.", "LIST", "NUMBERS", "OF", "ALL", "INVESTIGATIONAL", "NEW", "DRUG", "APPLICATIONS", "(21", "CFR", "Pan", "312),", "NEW", "DRUG", "OR", "ANTIBIOTIC", "APPLICATIONS", "(21", "CFR", "Part", "314).", "DRUG", "MASTER", "FILES", "(21", "CFR", "Part", "314.420),", "AND", "PRODUCT", "LICENSE", "APPLICATIONS", "(21", "CFR", "Part", "601)", "REFERRED", "TO", "IN", "THIS", "APPLICATION.", "N/A", "10.", "IND", "submission", "should", "be", "consecutively", "numbered.", "The", "Initial", "IND", "should", "be", "numbered", "\"Serial", "number:", "000.\"", "The", "next", "submission", "(e.g.,", "amendment,", "report,", "or", "correspondence)", "SERIAL", "NUMBER", "should", "be", "numbered", "\"Serial", "Number:", "001.\"", "Subsequent", "submissions", "should", "be", "numbered", "consecutively", "in", "the", "order", "In", "which", "they", "are", "submitted.", "5", "01", "$1.", "THIS", "SUBMISSION", "CONTAINS", "THE", "FOLLOWING:", "(Check", "all", "that", "apply)", "INITIAL", "INVESTIGATIONAL", "NEW", "DRUG", "APPLICATION", "(IND)", "O", "RESPONSE", "TO", "CLINICAL", "HOLD", "PROTOCOL", "AMENDMENT(S):", "INFORMATION", "AMENDMENT(S)", "IND", "SAFETY", "REPORT(S):", "NEW", "PROTOCOL", "100", "CHEMISTRY/MICROBIOLOGY", "INITIAL", "WRITTEN", "REPORT", "CHANGE", "IN", "PROTOCOL", "PHARMACOLOGY/TOXICOLOGY", "FOLLOW-UP", "TO", "A", "WRITTEN", "REPORT", "NEW", "INVESTIGATOR", "O", "CLINICAL", "RESPONSE", "TO", "FDA", "REQUEST", "FOR", "INFORMATION", "J", "ANNUAL", "REPORT", "O", "GENERAL", "CORRESPONDENCE", "\"REQUEST", "FOR", "REINSTATEMENT", "OF", "IND", "THAT", "IS", "WITHDRAWN.", "INACTIVATED,", "TERMINATED", "OR", "DISCONTINUED", "OTHER", "CHECK", "ONLY", "IF", "APPLICABLE", "JUSTIFICATION", "STATEMENT", "MUST", "BE", "SUBMITTED", "WITH", "APPLICATION", "FOR", "ANY", "CHECKED", "BELOW.", "REFER", "TO", "THE", "CITED", "CFR", "SECTION", "FOR", "FURTHER", "INFORMATION.", "TREATMENT", "IND", "21", "CFR", "312.36(b)", ":", "TREATMENT", "PROTOCOL", "21", "CFR", "312.35(*)", "[", "CHARGE", "REQUEST/NOTIFICATION", "21", "CFR312.7(d)", "FOR", "FDA", "USE", "ONLY", "COR/DBIND/DGD", "RECEIPT", "STAMP", "DOR", "RECEIPT", "STAM", "DIVISION", "ASSIGNMENT:", "IND", "NUMBER", "ASSIGNED:", "FORM", "FDA", "1571", "(9/02)", "PREVIOUS", "EDITION", "IS", "OBSOLETE.", "PAGE", "1", "OF", "2", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-INDNDA-01273549", "Produced", "in", "MDL", "on", "09/1", "1/2012", "Source:", "https://www.induptus/qcooogsts.ucsf.edu/docs/gyjf0226" ]

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{ "match_score": 1, "matched_text": "847-383-3739", "start": 629, "text": "847-383-3739" }

{ "de": "was ist das Ablaufdatum?", "en": "what is the expiration date ?", "es": "¿Cuál es la fecha de caducidad?", "fr": "Quelle est la date d'expiration?", "it": "Qual è la data di scadenza?" }

[ "November 30, 2002", "november 30, 2002" ]

[ "DEPARTMENT", "OF", "HEALTH", "AND", "HUMAN", "SERVICES", "Form", "Approved;", "OMB", "No.", "0910-0014", "PUBLIC", "HEALTH", "SERVICE", "Expiration", "Date:", "November", "30,", "2002", "FOOD", "AND", "DRUG", "ADMINISTRATION", "See", "OMB", "Statement", "on", "Reverse.", "INVESTIGATIONAL", "NEW", "DRUG", "APPLICATION", "(IND)", "NOTE:", "No", "drug", "may", "be", "shipped", "or", "clinical", "TITLE", "21,", "CODE", "OF", "FEDERAL", "REGULATIONS", "(CFR)", "PART", "312)", "investigation", "begun", "until", "an", "IND", "for", "that", "investigation", "is", "in", "effect", "(21", "CFR", "312.40)", ".", "NAME", "OF", "SPONSER", "2.", "DATE", "OF", "SUBMISSION", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "11/18/2002", "3.", "ADDRESS", "(Number,", "Street,", "City,", "State", "and", "Zip", "Code)", "4.", "TELEPHONE", "NUMBER", "(Include", "Area", "Code)", "475", "Half", "Day", "Road,", "Suite", "500", "847-383-3739", "Inshire,", "IL", "60069", "5.", "NAME(S)", "OF", "DRUG", "(Include", "all", "eveilable", "names:", "Trade,", "Generic,", "Chemical", "Code)", "6.", "IND", "NUMBER", "(If", "previously", "assigned)", "ACTOSO", "(pioglitazone", "HCI)", "33.729", "7.", "INDICATION(S)", "(Covered", "by", "this", "submission)", "NA", "B.", "PHASE(S)", "OF", "CLINICAL", "INVESTIGATION", "TO", "BE", "CONDUCTED:", "O", "PHASE", "1", "O", "PHASE2", "DPHASE3", "O", "OTHER", "NA", "(Specify)", "9.", "LIST", "NUMBERS", "OF", "ALL", "INVESTIGATIONAL", "NEW", "DRUG", "APPLICATIONS", "(21", "CFR", "Pan", "312),", "NEW", "DRUG", "OR", "ANTIBIOTIC", "APPLICATIONS", "(21", "CFR", "Part", "314).", "DRUG", "MASTER", "FILES", "(21", "CFR", "Part", "314.420),", "AND", "PRODUCT", "LICENSE", "APPLICATIONS", "(21", "CFR", "Part", "601)", "REFERRED", "TO", "IN", "THIS", "APPLICATION.", "N/A", "10.", "IND", "submission", "should", "be", "consecutively", "numbered.", "The", "Initial", "IND", "should", "be", "numbered", "\"Serial", "number:", "000.\"", "The", "next", "submission", "(e.g.,", "amendment,", "report,", "or", "correspondence)", "SERIAL", "NUMBER", "should", "be", "numbered", "\"Serial", "Number:", "001.\"", "Subsequent", "submissions", "should", "be", "numbered", "consecutively", "in", "the", "order", "In", "which", "they", "are", "submitted.", "5", "01", "$1.", "THIS", "SUBMISSION", "CONTAINS", "THE", "FOLLOWING:", "(Check", "all", "that", "apply)", "INITIAL", "INVESTIGATIONAL", "NEW", "DRUG", "APPLICATION", "(IND)", "O", "RESPONSE", "TO", "CLINICAL", "HOLD", "PROTOCOL", "AMENDMENT(S):", "INFORMATION", "AMENDMENT(S)", "IND", "SAFETY", "REPORT(S):", "NEW", "PROTOCOL", "100", "CHEMISTRY/MICROBIOLOGY", "INITIAL", "WRITTEN", "REPORT", "CHANGE", "IN", "PROTOCOL", "PHARMACOLOGY/TOXICOLOGY", "FOLLOW-UP", "TO", "A", "WRITTEN", "REPORT", "NEW", "INVESTIGATOR", "O", "CLINICAL", "RESPONSE", "TO", "FDA", "REQUEST", "FOR", "INFORMATION", "J", "ANNUAL", "REPORT", "O", "GENERAL", "CORRESPONDENCE", "\"REQUEST", "FOR", "REINSTATEMENT", "OF", "IND", "THAT", "IS", "WITHDRAWN.", "INACTIVATED,", "TERMINATED", "OR", "DISCONTINUED", "OTHER", "CHECK", "ONLY", "IF", "APPLICABLE", "JUSTIFICATION", "STATEMENT", "MUST", "BE", "SUBMITTED", "WITH", "APPLICATION", "FOR", "ANY", "CHECKED", "BELOW.", "REFER", "TO", "THE", "CITED", "CFR", "SECTION", "FOR", "FURTHER", "INFORMATION.", "TREATMENT", "IND", "21", "CFR", "312.36(b)", ":", "TREATMENT", "PROTOCOL", "21", "CFR", "312.35(*)", "[", "CHARGE", "REQUEST/NOTIFICATION", "21", "CFR312.7(d)", "FOR", "FDA", "USE", "ONLY", "COR/DBIND/DGD", "RECEIPT", "STAMP", "DOR", "RECEIPT", "STAM", "DIVISION", "ASSIGNMENT:", "IND", "NUMBER", "ASSIGNED:", "FORM", "FDA", "1571", "(9/02)", "PREVIOUS", "EDITION", "IS", "OBSOLETE.", "PAGE", "1", "OF", "2", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-INDNDA-01273549", "Produced", "in", "MDL", "on", "09/1", "1/2012", "Source:", "https://www.induptus/qcooogsts.ucsf.edu/docs/gyjf0226" ]

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{ "match_score": 1, "matched_text": "November 30, 2002", "start": 112, "text": "November 30, 2002" }

{ "de": "Wie lautet der Name des Sponsors?", "en": "what is the name of the sponsor ?", "es": "¿Cuál es el nombre del patrocinador?", "fr": "Quel est le nom du sponsor?", "it": "Qual è il nome dello sponsor?" }

[ "Takeda Pharmaceuticals North America, Inc.", "Takeda Pharmaceuticals North america , Inc." ]

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{ "match_score": 1, "matched_text": "Takeda Pharmaceuticals North America, Inc.", "start": 452, "text": "Takeda Pharmaceuticals North America, Inc." }

{ "de": "Was muss vor Beginn der Therapie mit Pioglitazon untersucht werden?", "en": "what has to be investigated before starting pioglitazone therapy?", "es": "¿Qué se debe investigar antes de iniciar el tratamiento con pioglitazona?", "fr": "Qu'est-ce qui doit être étudié avant le début du traitement par la pioglitazone?", "it": "Cosa deve essere studiato prima di iniziare la terapia con pioglitazone?" }

[ "any macroscopic haematuria" ]

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{ "match_score": 0.9615384630177515, "matched_text": "Any macroscopic haematuria", "start": 1236, "text": "any macroscopic haematuria" }

{ "de": "Wie wurde häufig bei Patienten, die Actos in Kombination mit Insulin eingenommen haben, berichtet?", "en": "what has been experienced commonly in patients taking actos in combination with insulin?", "es": "¿Qué se ha experimentado con frecuencia en pacientes que toman actos en combinación con insulina?", "fr": "Quelles ont été les expériences courantes chez les patients prenant des actos en association avec l'insuline?", "it": "che cosa si è verificato comunemente nei pazienti che assumevano Actos in associazione con insulina?" }

[ "Heart failure", "heart failure" ]

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{ "match_score": 1, "matched_text": "Heart failure", "start": 2487, "text": "Heart failure" }

{ "de": "Welche Stiftung wird in diesem Dokument erwähnt?", "en": "Which foundation is mentioned in this document?", "es": "¿Qué fundamento se menciona en este documento?", "fr": "Quelle est la fondation mentionnée dans ce document?", "it": "Quale fondamento è menzionato in questo documento?" }

[ "Cleveland Clinic Foundation", "The Cleveland Clinic Foundation" ]

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{ "match_score": 1, "matched_text": "Cleveland Clinic Foundation", "start": 187, "text": "Cleveland Clinic Foundation" }

{ "de": "Unter welcher Abteilung ist die Cleveland Clinic Foundation tätig?", "en": "Under which department , The Cleveland Clinic Foundation operates?", "es": "¿Bajo qué departamento opera la Cleveland Clinic Foundation?", "fr": "Sous quel département la Fondation des cliniques de Cleveland fonctionne-t-elle?", "it": "In quale dipartimento opera la Cleveland Clinic Foundation?" }

[ "Department of Cardiovascular Medicine", "Department of Cardiovascular Medicine." ]

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{ "match_score": 1, "matched_text": "Department of Cardiovascular Medicine", "start": 215, "text": "Department of Cardiovascular Medicine" }

{ "de": "Was ist in großen fetten Buchstaben unten geschrieben?", "en": "What is written in big bold letters at the bottom?", "es": "¿Qué está escrito en grandes letras en negrita en la parte inferior?", "fr": "Qu'est-ce qui est écrit en grandes lettres audacieuses en bas?", "it": "Cosa c'è scritto in lettere audaci in fondo?" }

[ "DALY 19" ]

[ "FROM", "HERETAN", "DEMAS", "FAX05-6204-2943", "19994", "18218", "(*)", "21", "31/21", ":", "28/x56:480:", "941295", "F", "1", "Takeda", "Chemical", "Industries,", "Ltd.", "Takeda", "Product", "Planning", "&", "Management", "Dept.,", "International", "Division", "1-1", "Doshomachi", "4-chome,", "Chuo-Ku,", "Osaka", "541,", "JAPAN", "Tel:", "+81", "6", "(204)", "2852", "Fax:", "+81", "6", "(204)", "2943", "TELEFAX", "MESSAGE", "To:", "E.", "Lilly", "&", "Company", "Date:", "January", "21,", "1999", "Att:", "Mr.", "Larry", "Ellingson", "From:", "Kunio", "Iwatani", "Executive", "Director", "Actos", "Product", "Team", "CC:", "Mr.", "Hamanaka,", "TPA", "Subject:", "Upjohn", "Matter", "Dear", "Mr.", "Ellingson,", "Enclosed", "please", "find", "a", "copy", "of", "Upjohn's", "letter", "to", "US", "FDA", "dated", "January", "7,", "1994.", "In", "the", "letter", "Upjohn", "said", "that", "in", "preliminary", "clinical", "evaluation", "in", "the", "United", "States,", "pioglitazone", "did", "not", "satisfy", "Upjohn's", "internal", "requirement", "for", "reduction", "blood", "glucose;", "therefore,", "the", "considerable", "programs", "required", "for", "development", "of", "pioglitazone", "are", "not", "in", "line", "with", "Upjohn's", "business", "needs.", "-..", "They", "did", "not", "mention", "about", "safety", "of", "pioglitazone.", "After", "Upjohn's", "decision,", "Takeda", "approached", "FDA", "and", "consulted", "whether", "Takeda", "might", "go", "further", "the", "clinical", "development", "works", "on", "pioglitazone.", "Since", "the", "FDA's", "response", "was", "positive", "to", "go", "ahead,", "Takeda", "took", "over", "Upjohn's", "works", "and", "finally", "filed", "NDA", "on", "January", "15,", "1999.", "This", "is", "the", "story", "of", "the", "fact.", "Although", "there", "may", "be", "rumors", "about", "the", "reasons", "of", "Upjohn's", "abandonment", "of", "pioglitazone", "development,", "specially", "from", "the", "viewpoints", "of", "safety", "issues,", "it", "might", "be", "advisable", "for", "us", "to", "keep", "saying", "that", "Upjohn's", "decision", "is", "based", "on", "JAN", "21", "'99", "07:43", "DALY", "19", "06", "6204", "2943", "PAGE", ".", "01", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-CRCARCH-00003000", "Source:", "https://www.indupbodsfoodonts.ucsf.edu/docs/nljf0226" ]

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{ "match_score": 1, "matched_text": "DALY 19", "start": 1466, "text": "DALY 19" }

{ "de": "Welches Arzneimittel wird zur Behandlung des Typ-2-Diabetes mellitus angewendet?", "en": "Which medicine is used to treat type 2 diabetes mellitus?", "es": "¿Qué medicamento se utiliza para tratar la diabetes mellitus tipo 2?", "fr": "Quel médicament est utilisé pour traiter le diabète de type 2?", "it": "Quale medicinale viene usato per trattare il diabete mellito di tipo 2?" }

[ "Actos/Competact" ]

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{ "match_score": 1, "matched_text": "Actos/Competact", "start": 1671, "text": "Actos/Competact" }

{ "de": "Wie viele Fälle von Blasenkrebs von 12506 Patienten wurden berichtet?", "en": "How many cases of bladder cancer from 12506 patients were reported?", "es": "¿Cuántos casos de cáncer de vejiga de 12506 pacientes fueron reportados?", "fr": "Combien de cas de cancer de la vessie ont été rapportés chez 12506 patients?", "it": "Quanti casi di cancro alla vescica sono stati segnalati da 12506 pazienti?" }

[ "19 cases" ]

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{ "match_score": 1, "matched_text": "19 cases", "start": 346, "text": "19 cases" }

{ "de": "Wie lautet die Postfachnummer?", "en": "What is the PO Box number?", "es": "¿Cuál es el número de la casilla de correos?", "fr": "Quel est le numéro de la boîte postale?", "it": "Qual è il numero della casella postale?" }

[ "931535" ]

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"foregoing", "restrictions", "on", "use", "and", "disclosure", "shall", "not", "apply", "to", "Confidential", "Information", "which", "Institution", "can", "prove:", "(1", "was", "in", "its", "possession", "as", "evidenced", "by", "written", "records,", "pre-dating", "disclosure", "hereunder;", "(1i)", "was", "or", "became", "public", "knowledge", "through", "no", "fault", "of", "Institution:", "(iii)", "was", "disclosed", "to", "Institution", "by", "a", "third", "party", "who", "was", "not", "bound", "by", "any", "confidentiality", "restriction", "and", "did", "not", "so", "bind", "Institution;", "or", "(iv)", "was", "required", "to", "be", "disclosed", "by", "law,", "court", "order", "or", "other", "governmental", "order", "on", "demand;", "provided", "Institution", "shall", "immediately", "notify", "TORD", "in", "writing", "and", "allow", "TGRD", "to", "attempt", "to", "limit", "disclosure", "by", "appropriate", "legal", "means.", "Failing", "such", "efforts", "Institution", 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{ "match_score": 1, "matched_text": "931535", "start": 277, "text": "931535" }

{ "de": "was ist das IND mumber (wenn zuvor zugewiesen )?", "en": "what is the IND mumber (if previously assigned ) ?", "es": "¿Qué es el IND mumber (si se ha asignado previamente )?", "fr": "qu'est-ce que l'IND mumber (si précédemment assigné )?", "it": "che cos'è il legname IND (se precedentemente assegnato)?" }

[ "33,729" ]

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{ "match_score": 0.8333333611111065, "matched_text": "33,72 ", "start": 807, "text": "33,729" }

{ "de": "Wie lautet das Datum der Einreichung?", "en": "what is the date of submission ?", "es": "¿Cuál es la fecha de presentación?", "fr": "Quelle est la date de présentation?", "it": "Qual è la data di presentazione?" }

[ "11/1/02" ]

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{ "match_score": 0.8750000156249981, "matched_text": "1 1/1/02", "start": 498, "text": "11/1/02" }

{ "de": "was ist der Name(n) des Arzneimittels (enthält alle verfügbaren Namen: Trade, Generic, Chemical, Code)?", "en": "what is the Name(s) of drug (include all available names: Trade , Generic, Chemical, Code)?", "es": "¿Cuál es el(los) nombre(s) de la droga (incluye todos los nombres disponibles: Comercio, Genérico, Química, Código)?", "fr": "Quel est le(s) nom(s) du(des) médicament(s) (comprend(nt) tous les noms disponibles : commerce, générique, chimique, code)?", "it": "Qual è il nome (i) del farmaco (includere tutti i nomi disponibili: Commercio, Generico, Chimico, Codice)?" }

[ "ACTOS (pioglitazone HCI)", "ACTOS (Pioglitazone HCI)" ]

[ "DEPARTMENT", "OF", "HEALTH", "AND", "HUMAN", "SERVICES", "Form", "Approved:", "OMB", "No.", "0910-0014", "PUBLIC", "HEALTH", "SERVICE", "Expiration", "Date:", "November", "30,", "2002", "FOOD", "AND", "DRUG", "ADMINISTRATION", "See", "OMB", "Statement", "on", "Reverse,", "INVESTIGATIONAL", "NEW", "DRUG", "APPLICATION", "(IND)", "NOTE:", "No", "drug", "may", "be", "shipped", "or", "clinical", "(TITLE", "21,", "CODE", "OF", "FEDERAL", "REGULATIONS", "(CFR)", "PART", "312)", "Investigation", "begun", "until", "an", "IND", "for", "that", "investigation", "is", "in", "effect", "(21", "CFR", "312.40).", "1.", "NAME", "OF", "SPONSER", "2.", "DATE", "OF", "SUBMISSION", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "1", "1/1/02", "3.", "ADDRESS", "(Number,", "Street,", "City,", "State", "and", "Zip", "Code)", "4.", "TELEPHONE", "NUMBER", "(Include", "Area", "Code)", "475", "Half", "Day", "Road,", "Suite", "500", "847-383-324.", "oinshire,", "IL", "60069", "5.", "NAME(S)", "OF", "DRUG", "(Include", "all", "available", "names:", "Trade,", "Generic,", "Chemical,", "Code)", "6.", "IND", "NUMBER", "(if", "previously", "assigned)", "ACTOS@", "(pioglitazone", "HCI", "33,72", "7.", "INDICATION(S)", "(Covered", "by", "the", "N/A", "8.", "PHASE(S)", "OF", "CLINICAL", "INVESTIGATION", "TO", "BE", "CONDUCTED:", "O", "PHASE", "1", "0", "PHASE", "2", "PHASE", "3", ")", "OTHER", "N/A", "(Specify)", "9.", "LIST", "NUMBERS", "OF", "ALL", "INVESTIGATIONAL'", "NEW", "DRUG", "APPLICATIONS", "(21", "CFR", "Part", "312),", "NEW", "DRUG", "OR", "ANTIBIOTIC", "APPLICATIONS", "(21", "CFR", "Part", "314).", "DRUG", "MASTER", "FILES", "(21", "CFR", "Part", "314.420),", "AND", "PRODUCT", "LICENSE", "APPLICATIONS", "(21", "CFR", "Part", "601)", "REFERRED", "TO", "IN", "THIS", "APPLICATION.", "N/A", "10.", "IND", "submission", "should", "be", "consecutively", "numbered.", "The", "Initial", "IND", "should", "be", "numbered", "\"Serial", "number:", "000.\"", "The", "next", "submission", "(e.g.,", "amendment,", "report,", "or", "correspondence)", "SERIAL", "NUMBER", "should", "be", "numbered", "\"Serial", "Number:", "001.\"", "Subsequent", "submissions", "should", "be", "numbered", "consecutively", "in", "the", "order", "in", "which", "they", "are", "submitted.", "4", "7", "11.", "THIS", "SUBMISSION", "CONTAINS", "THE", "FOLLOWING:", "(Check", "all", "that", "apply)", "C)", "INITIAL", "INVESTIGATIONAL", "NEW", "DRUG", "APPLICATION", "(IND)", "ORESPONSE", "TO", "CLINICAL", "HOLD", "PROTOCOL", "AMENDMENT(S):", "INFORMATION", "AMENDMENT(S):", "IND", "SAFETY", "REPORT(S)", "NEW", "PROTOCOL", "\"CHEMISTRY/MICROBIOLOGY", "[]", "PHARMACOLOGY/TOXICOLOGY", "INITIAL", "WRITT", "CHANGE", "IN", "PROTOCOL", "FOLLOW-UP", "TO", "A", "WRITTEN", "REPORT", "O", "NEW", "INVESTIGATOR", "CLINICAL", "X", "RESPONSE", "TO", "FDA", "REQUEST", "FOR", "INFORMATION", "OANNUAL", "REPORT", "GENERAL", "CORRESPONDENCE", "\"", "REQUEST", "FOR", "REINSTATEMENT", "OF", "IND", "THAT", "IS", "WITHDRAWN,", "INACTIVATED,", "TERMINATED", "OR", "DISCONTINUED", "OTHER", "(Specify)", "CHECK", "ONLY", "IF", "APPLICABLE", "JUSTIFICATION", "STATEMENT", "MUST", "BE", "SUBMITTED", "WITH", "APPLICATION", "FOR", "ANY", "CHECKED", "BELOW.", "REFER", "TO", "THE", "CITED", "CFR", "SECTION", "FOR", "FURTHER", "INFORMATION.", "TREATMENT", "IND", "21", "CFR", "312.35(b)", "[TREATMENT", "PROTOCOL", "21", "CFR", "312.35(a)", "[", "CHARGE", "REQUEST/NOTIFICATION", "21", "CFR312.7(d)", "FOR", "FDA", "USE", "ONLY", "CDR/DBIND/DGD", "RECEIPT", "STAMP", "DDR", "RECEIPT", "STAMP", "DIVISION", "ASSIGNMENT:", "IND", "NUMBER", "ASSIGNED", "FORM", "FDA", "1571", "(9/02)", "PREVIOUS", "EDITION", "IS", "OBSOLETE.", "PAGE", "1", "OF", "2", "PSC", "Media", "Arts", "Branch", "(301)", "643-1090", "ER", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00015505", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indup2292-00003s.ucsf.edu/docs/tyjf0226" ]

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{ "match_score": 0.9200000031999999, "matched_text": "ACTOS@ (pioglitazone HCI ", "start": 782, "text": "ACTOS (pioglitazone HCI)" }

{ "de": "Was ist die Steuer-ID in diesem Dokument erwähnt?", "en": "What is the Tax ID mentioned in this document?", "es": "¿Cuál es la identificación fiscal mencionada en este documento?", "fr": "Quel est le numéro d'identification fiscal mentionné dans ce document?", "it": "Che cosa è l'ID fiscale menzionato in questo documento?" }

[ "34-0714585" ]

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{ "match_score": 1, "matched_text": "34-0714585", "start": 319, "text": "34-0714585" }

{ "de": "was ist das Formular genehmigt : OMB Nein", "en": "what is the form approved : OMB No", "es": "Cuál es el formulario aprobado : No OMB", "fr": "quel est le formulaire approuvé : OMB Non", "it": "Qual è il modulo approvato : OMB No" }

[ "0910-0014", "0910-0014." ]

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{ "match_score": 1, "matched_text": "0910-0014", "start": 63, "text": "0910-0014" }

{ "de": "Was ist das Wort in Fettdruck auf der Oberseite des Dokuments geschrieben?", "en": "What is the word written in bold on the top of the document?", "es": "¿Cuál es la palabra escrita en negrita en la parte superior del documento?", "fr": "Quel est le mot écrit en gras en haut du document?", "it": "Qual è la parola scritta in grassetto sulla parte superiore del documento?" }

[ "Takeda" ]

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{ "match_score": 1, "matched_text": "Takeda", "start": 0, "text": "Takeda" }

{ "de": "Wie lautet das erwähnte Datum?", "en": "What is the date mentioned?", "es": "¿Cuál es la fecha mencionada?", "fr": "Quelle est la date mentionnée?", "it": "Qual è la data indicata?" }

[ "19th January 2012" ]

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{ "match_score": 0.866666675555555, "matched_text": "19 January 2012", "start": 7, "text": "19th January 2012" }

{ "de": "Wie lautet der Name der Pharmazeutika?", "en": "what is the name of pharmaceuticals ?", "es": "¿Cuál es el nombre de los productos farmacéuticos?", "fr": "Quel est le nom des produits pharmaceutiques?", "it": "Qual è il nome dei prodotti farmaceutici?" }

[ "Takeda Pharmaceuticals North America, Inc.", "TAkeda pharmaceuticals North America ,INc." ]

[ "DEPARTMENT", "OF", "HEALTH", "&", "HUMAN", "SERVICES", "Public", "Health", "Service", "Food", "and", "Drug", "Administration", "Rockville,", "MD", "20857", "IND", "33,729", "RECEIVED", "REGULATORY", "AFFAIRS", "DEPARTMENT", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "Attention:", "Janet", "L.", "Haskin", "JUN", "1", "6", "2003", "Manager,", "Regulatory", "Affairs", "475", "Half", "Day", "Road,", "Suite", "500", "Takeda", "Pharmaceuticals", "North", "America,", "Ins", "Lincolnshire,", "IL", "60069", "Dear", "Ms.", "Haskins:", "Please", "refer", "to", "your", "Investigational", "New", "Drug", "Application", "(IND)", "submitted", "January", "15,", "1999,", "under", "section", "505(i)", "of", "the", "Federal", "Food,", "Drug,", "and", "Cosmetic", "Act", "for", "Actos", "(pioglitazone", "HCI)", "Tablets,", "15", "mg,", "30", "mg", "and", "45", "mg", "We", "also", "refer", "to", "your", "amendment", "dated", "May", "8,", "2003", "(serial", "#", "525),", "received", "on", "May", "9,", "2003,", "that", "provided", "a", "response", "to", "our", "November", "13,", "2002,", "letter", "which", "cited", "the", "reasons", "this", "protocol", "was", "placed", "on", "clinical", "hold", "and", "the", "information", "needed", "to", "resolve", "the", "clinical", "hold", "issues.", "We", "have", "completed", "the", "review", "of", "your", "submission", "and", "have", "concluded", "that", "removal", "of", "the", "clinical", "hold", "is", "not", "warranted.", "We", "acknowledge", "your", "agreement", "to", "monitor", "for", "bladder", "tumors", "in", "your", "clinical", "studies,", "and", "to", "amend", "the", "label", "and", "consent", "documents.", "However,", "until", "further", "information", "on", "bladder", "effects", "from", "ongoing", "studies", "is", "available,", "we", "do", "not", "believe", "studies", "in", "pediatric", "patients", "are", "warranted.", "Until", "you", "have", "submitted", "the", "required", "information", "and", "we", "notify", "you", "that", "you", "may", "initiate", "trials,", "this", "IND", "remains", "on", "clinical", "hold", "and", "you", "may", "not", "legally", "conduct", "clinical", "studies", "under", "it.", "Please", "identify", "your", "response", "to", "the", "clinical", "hold", "issues", "as", "a", "\"CLINICAL", "HOLD", "COMPLETE", "RESPONSE.\"", "To", "facilitate", "a", "response", "to", "your", "submission,", "submit", "this", "information", "in", "triplicate", "to", "the", "IND.", "In", "addition,", "send", "a", "copy", "of", "the", "cover", "letter", "to", "Ms.", "Jena", "Weber.", "Following", "receipt", "of", "your", "complete", "response", "to", "these", "issues,", "we", "will", "notify", "you", "of", "our", "decision", "within", "30", "days.", "424", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-INDNDA-01577085", "in", "MDL", "on", "01/31/13", "Source:", "https://www.induptrygg-ooooits.ucsf.edu/docs/xyjf0226" ]

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{ "match_score": 1, "matched_text": "Takeda Pharmaceuticals North America, Inc.", "start": 159, "text": "Takeda Pharmaceuticals North America, Inc." }

{ "de": "an wen dieser Brief geschrieben wird?", "en": "to whom this letter is written ?", "es": "¿A quién está escrita esta carta?", "fr": "à qui cette lettre est-elle écrite?", "it": "a chi è scritta questa lettera?" }

[ "Janet L. Haskins", "janet L. haskins", "Ms. Haskins" ]

[ "DEPARTMENT", "OF", "HEALTH", "&", "HUMAN", "SERVICES", "Public", "Health", "Service", "Food", "and", "Drug", "Administration", "Rockville,", "MD", "20857", "IND", "33,729", "RECEIVED", "REGULATORY", "AFFAIRS", "DEPARTMENT", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "Attention:", "Janet", "L.", "Haskin", "JUN", "1", "6", "2003", "Manager,", "Regulatory", "Affairs", "475", "Half", "Day", "Road,", "Suite", "500", "Takeda", "Pharmaceuticals", "North", "America,", "Ins", "Lincolnshire,", "IL", "60069", "Dear", "Ms.", "Haskins:", "Please", "refer", "to", "your", "Investigational", "New", "Drug", "Application", "(IND)", "submitted", "January", "15,", "1999,", "under", "section", "505(i)", "of", "the", "Federal", "Food,", "Drug,", "and", "Cosmetic", "Act", "for", "Actos", "(pioglitazone", "HCI)", "Tablets,", "15", "mg,", "30", "mg", "and", "45", "mg", "We", "also", "refer", "to", "your", "amendment", "dated", "May", "8,", "2003", "(serial", "#", "525),", "received", "on", "May", "9,", "2003,", "that", "provided", "a", "response", "to", "our", "November", "13,", "2002,", "letter", "which", "cited", "the", "reasons", "this", "protocol", "was", "placed", "on", "clinical", "hold", "and", "the", "information", "needed", "to", "resolve", "the", "clinical", "hold", "issues.", "We", "have", "completed", "the", "review", "of", "your", "submission", "and", "have", "concluded", "that", "removal", "of", "the", "clinical", "hold", "is", "not", "warranted.", "We", "acknowledge", "your", "agreement", "to", "monitor", "for", "bladder", "tumors", "in", "your", "clinical", "studies,", "and", "to", "amend", "the", "label", "and", "consent", "documents.", "However,", "until", "further", "information", "on", "bladder", "effects", "from", "ongoing", "studies", "is", "available,", "we", "do", "not", "believe", "studies", "in", "pediatric", "patients", "are", "warranted.", "Until", "you", "have", "submitted", "the", "required", "information", "and", "we", "notify", "you", "that", "you", "may", "initiate", "trials,", "this", "IND", "remains", "on", "clinical", "hold", "and", "you", "may", "not", "legally", "conduct", "clinical", "studies", "under", "it.", "Please", "identify", "your", "response", "to", "the", "clinical", "hold", "issues", "as", "a", "\"CLINICAL", "HOLD", "COMPLETE", "RESPONSE.\"", "To", "facilitate", "a", "response", "to", "your", "submission,", "submit", "this", "information", "in", "triplicate", "to", "the", "IND.", "In", "addition,", "send", "a", "copy", "of", "the", "cover", "letter", "to", "Ms.", "Jena", "Weber.", "Following", "receipt", "of", "your", "complete", "response", "to", "these", "issues,", "we", "will", "notify", "you", "of", "our", "decision", "within", "30", "days.", "424", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-INDNDA-01577085", "in", "MDL", "on", "01/31/13", "Source:", "https://www.induptrygg-ooooits.ucsf.edu/docs/xyjf0226" ]

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{ "match_score": 0.9375000039062498, "matched_text": "Janet L. Haskin ", "start": 213, "text": "Janet L. Haskins" }

{ "de": "Wann hat die Abteilung für Regulatorische Angelegenheiten diesen Brief erhalten?", "en": "When did Regulatory affairs department receive this letter?", "es": "¿Cuándo recibió el Departamento de Asuntos Regulatorios esta carta?", "fr": "Quand le ministère des Affaires réglementaires a-t-il reçu cette lettre?", "it": "Quando ha ricevuto questa lettera il Dipartimento Affari Regolatori?" }

[ "JUN 16 2003" ]

[ "DEPARTMENT", "OF", "HEALTH", "&", "HUMAN", "SERVICES", "Public", "Health", "Service", "Food", "and", "Drug", "Administration", "Rockville,", "MD", "20857", "IND", "33,729", "RECEIVED", "REGULATORY", "AFFAIRS", "DEPARTMENT", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "Attention:", "Janet", "L.", "Haskin", "JUN", "1", "6", "2003", "Manager,", "Regulatory", "Affairs", "475", "Half", "Day", "Road,", "Suite", "500", "Takeda", "Pharmaceuticals", "North", "America,", "Ins", "Lincolnshire,", "IL", "60069", "Dear", "Ms.", "Haskins:", "Please", "refer", "to", "your", "Investigational", "New", "Drug", "Application", "(IND)", "submitted", "January", "15,", "1999,", "under", "section", "505(i)", "of", "the", "Federal", "Food,", "Drug,", "and", "Cosmetic", "Act", "for", "Actos", "(pioglitazone", "HCI)", "Tablets,", "15", "mg,", "30", "mg", "and", "45", "mg", "We", "also", "refer", "to", "your", "amendment", "dated", "May", "8,", "2003", "(serial", "#", "525),", "received", "on", "May", "9,", "2003,", "that", "provided", "a", "response", "to", "our", "November", "13,", "2002,", "letter", "which", "cited", "the", "reasons", "this", "protocol", "was", "placed", "on", "clinical", "hold", "and", "the", "information", "needed", "to", "resolve", "the", "clinical", "hold", "issues.", "We", "have", "completed", "the", "review", "of", "your", "submission", "and", "have", "concluded", "that", "removal", "of", "the", "clinical", "hold", "is", "not", "warranted.", "We", "acknowledge", "your", "agreement", "to", "monitor", "for", "bladder", "tumors", "in", "your", "clinical", "studies,", "and", "to", "amend", "the", "label", "and", "consent", "documents.", "However,", "until", "further", "information", "on", "bladder", "effects", "from", "ongoing", "studies", "is", "available,", "we", "do", "not", "believe", "studies", "in", "pediatric", "patients", "are", "warranted.", "Until", "you", "have", "submitted", "the", "required", "information", "and", "we", "notify", "you", "that", "you", "may", "initiate", "trials,", "this", "IND", "remains", "on", "clinical", "hold", "and", "you", "may", "not", "legally", "conduct", "clinical", "studies", "under", "it.", "Please", "identify", "your", "response", "to", "the", "clinical", "hold", "issues", "as", "a", "\"CLINICAL", "HOLD", "COMPLETE", "RESPONSE.\"", "To", "facilitate", "a", "response", "to", "your", "submission,", "submit", "this", "information", "in", "triplicate", "to", "the", "IND.", "In", "addition,", "send", "a", "copy", "of", "the", "cover", "letter", "to", "Ms.", "Jena", "Weber.", "Following", "receipt", "of", "your", "complete", "response", "to", "these", "issues,", "we", "will", "notify", "you", "of", "our", "decision", "within", "30", "days.", "424", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-INDNDA-01577085", "in", "MDL", "on", "01/31/13", "Source:", "https://www.induptrygg-ooooits.ucsf.edu/docs/xyjf0226" ]

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{ "match_score": 0.9166666736111105, "matched_text": "JUN 1 6 2003", "start": 229, "text": "JUN 16 2003" }

{ "de": "An wen wurde dieser Brief geschrieben?", "en": "To whom was this letter written?", "es": "¿A quién escribió esta carta?", "fr": "À qui cette lettre a-t-elle été écrite?", "it": "A chi è stata scritta questa lettera?" }

[ "Healthcare Professional" ]

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{ "match_score": 1, "matched_text": "Healthcare Professional", "start": 30, "text": "Healthcare Professional" }

{ "de": "Was ist der fünfte Punkt?", "en": "What is the fifth point?", "es": "¿Cuál es el quinto punto?", "fr": "Quel est le cinquième point?", "it": "Qual è il quinto punto?" }

[ "WAC and AWP generally;", "WAC AND AWP generally;" ]

[ "3.", "Reports", "to", "any", "third", "party,", "including,", "but", "not", "limited", "to,", "RedBook,", "First", "Data", "Bank,", "Blue", "Book,", "Medi-Span,", "or", "other", "price", "reporting", "service,", "regarding", "prices", "for", "TPNA", "products;", "4.", "Communications", "with", "RedBook,", "First", "Data", "Bank,", "Blue", "Book,", "Medi-Span,", "or", "other", "pricing", "reporting", "services,", "regarding", "prices", "for", "TPNA", "products;", "5.", "WAC", "and", "AWP", "generally;", "6.", "Medicare", "and", "Medicaid", "reimbursement", "for", "TPNA", "pharmaceutical", "products", "generally;", "7.", "Calculation", "and", "reporting", "of", "Average", "Manufacturer", "Price", "and", "Best", "Price", "for", "TPNA", "products,", "as", "may", "be", "required", "by", "federal", "and", "state", "laws", "and", "regulations;", "8.", "Communications", "with", "any", "state", "or", "federal", "governmental", "agency", "regarding", "TPNA's", "participation", "in", "the", "Medicaid", "program;", "9.", "Invoices,", "internal", "sales", "projections,", "and", "profit", "statements", "that", "indicate", "the", "price", "TPNA", "paid", "for", "its", "products", "and", "the", "profits", "IPNA", "made", "based", "upon", "sales", "of", "these", "products;", "10.", "Meetings", "at", "which", "sales,", "marketing,", "and", "pricing", "decisions", "were", "discussed;", "11.", "Communications", "with", "providers,", "if", "any,", "relating", "to", "the", "use", "of", "the", "terms", "\"spread\"", "or", "\"profit\"", "in", "the", "context", "of", "the", "sale", "or", "marketing", "of", "TPNA", "products;", "12.", "Marketing", "materials", "(including", "proposed", "materials),", "if", "any,", "relating", "to", "the", "cost", "and", "\"spread\"", "for", "TPNA", "products;", "13.", "Provision", "of", "free", "samples", "or", "nominally", "priced", "TPNA", "products", "to", "any", "providers;", "and", "14.", "Educational", "grants", "regarding", "TPNA", "products;", "These", "requirements", "are", "related", "to", "all", "TPNA", "marketed", "products.", "Each", "Takeda", "Employee", "or", "Contractor", "shall", "create", "an", "Outlook", "Folder", "entitled", "\"AWP\"", "beneath", "the", "\"Legal", "Hold\"", "folder", "provided", "as", "part", "of", "the", "implementation", "of", "CORP-B-019", "\"E-mail", "Management", "and", "Retention.\"", "Contact", "the", "Help", "Desk", "if", "your", "Outlook", "file", "folder", "structure", "does", "not", "contain", "a", "\"Legal", "Hold\"", "folder.", "This", "means", "that", "all", "documents,", "materials,", "and", "computer", "files", "(including", "e-mails,", "word", "processing", "documents,", "slides,", "etc.)", "falling", "into", "this", "category", "must", "continue", "to", "be", "maintained", "until", "you", "are", "informed", "otherwise,", "regardless", "of", "the", "specified", "record", "retention", "period", "that", "would", "apply", "to", "such", "materials", "under", "Takeda's", "current", "Records", "Retention", "Schedules", "and", "program.", "You", "are", "reminded", "that", "you", "must", "follow", "the", "requirements", "of", "BOP,", "CORP-B-019", "\"E-mail", "Management", "and", "Retention\"", "for", "the", "retention", "of", "electronic", "materials,", "and", "the", "\"Best", "Practices", "For", "The", "Physical", "And", "Electronic", "Storage", "Of", "Materials", "That", "Must", "Be", "Retained", "For", "Legal", "Reasons....\"", "IN", "ALL", "CASES,", "THE", "FOLLOWING", "INSTRUCTIONS", "APPLY", "TO", "DOCUMENTS,", "MATERIALS,", "INFORMATION,", "AND", "THINGS,", "IN", "HARD", "COPY", "OR", "ELECTRONIC", "FORMAT,", "THAT", "ARE", "REQUIRED", "TO", "BE", "RETAINED", "PURSUANT", "TO", "THIS", "LEGAL", "HOLD.", "Last", "printed", "11/30/2012", "4:28:00", "AM", "20122830-042845", "doc", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RIM30b6-00000665", "Source:", "https://www.indup5316-@0003ts.ucsf.edu/docs/frjf0226" ]

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{ "match_score": 1, "matched_text": "WAC and AWP generally;", "start": 327, "text": "WAC and AWP generally;" }

{ "de": "Bildungsstipendien für welche Produkte?", "en": "Education grants regarding which products?", "es": "¿Subvenciones de educación con respecto a qué productos?", "fr": "Bourses d'études pour quels produits?", "it": "Borse di studio relative a quali prodotti?" }

[ "TPNA", "TPNA products" ]

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{ "match_score": 1, "matched_text": "TPNA", "start": 165, "text": "TPNA" }

{ "de": "Wie lautet das Datum, an dem dieses Dokument zuletzt gedruckt wurde?", "en": "What is the date this document was last printed?", "es": "¿Cuál es la fecha de la última impresión de este documento?", "fr": "Quelle est la date à laquelle ce document a été imprimé pour la dernière fois?", "it": "Qual è la data in cui questo documento è stato stampato l'ultima volta?" }

[ "11/30/2012", "11/30/2012 4:28:00 AM" ]

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{ "match_score": 1, "matched_text": "11/30/2012", "start": 2576, "text": "11/30/2012" }

{ "de": "An wen muss eine Kopie des Anschreibens geschickt werden?", "en": "To whom a copy of cover letter has to be sent ?", "es": "¿A quién hay que enviar una copia de la carta de presentación?", "fr": "À qui une copie de la lettre d'accompagnement doit-elle être envoyée?", "it": "A chi deve essere inviata una copia della lettera di accompagnamento?" }

[ "Ms. Jens Weber" ]

[ "DEPARTMENT", "OF", "HEALTH", "&", "HUMAN", "SERVICES", "Public", "Health", "Service", "Food", "and", "Drug", "Administration", "Rockville,", "MD", "20857", "IND", "33,729", "RECEIVED", "REGULATORY", "AFFAIRS", "DEPARTMENT", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "Attention:", "Janet", "L.", "Haskin", "JUN", "1", "6", "2003", "Manager,", "Regulatory", "Affairs", "475", "Half", "Day", "Road,", "Suite", "500", "Takeda", "Pharmaceuticals", "North", "America,", "Ins", "Lincolnshire,", "IL", "60069", "Dear", "Ms.", "Haskins:", "Please", "refer", "to", "your", "Investigational", "New", "Drug", "Application", "(IND)", "submitted", "January", "15,", "1999,", "under", "section", "505(i)", "of", "the", "Federal", "Food,", "Drug,", "and", "Cosmetic", "Act", "for", "Actos", "(pioglitazone", "HCI)", "Tablets,", "15", "mg,", "30", "mg", "and", "45", "mg", "We", "also", "refer", "to", "your", "amendment", "dated", "May", "8,", "2003", "(serial", "#", "525),", "received", "on", "May", "9,", "2003,", "that", "provided", "a", "response", "to", "our", "November", "13,", "2002,", "letter", "which", "cited", "the", "reasons", "this", "protocol", "was", "placed", "on", "clinical", "hold", "and", "the", "information", "needed", "to", "resolve", "the", "clinical", "hold", "issues.", "We", "have", "completed", "the", "review", "of", "your", "submission", "and", "have", "concluded", "that", "removal", "of", "the", "clinical", "hold", "is", "not", "warranted.", "We", "acknowledge", "your", "agreement", "to", "monitor", "for", "bladder", "tumors", "in", "your", "clinical", "studies,", "and", "to", "amend", "the", "label", "and", "consent", "documents.", "However,", "until", "further", "information", "on", "bladder", "effects", "from", "ongoing", "studies", "is", "available,", "we", "do", "not", "believe", "studies", "in", "pediatric", "patients", "are", "warranted.", "Until", "you", "have", "submitted", "the", "required", "information", "and", "we", "notify", "you", "that", "you", "may", "initiate", "trials,", "this", "IND", "remains", "on", "clinical", "hold", "and", "you", "may", "not", "legally", "conduct", "clinical", "studies", "under", "it.", "Please", "identify", "your", "response", "to", "the", "clinical", "hold", "issues", "as", "a", "\"CLINICAL", "HOLD", "COMPLETE", "RESPONSE.\"", "To", "facilitate", "a", "response", "to", "your", "submission,", "submit", "this", "information", "in", "triplicate", "to", "the", "IND.", "In", "addition,", "send", "a", "copy", "of", "the", "cover", "letter", "to", "Ms.", "Jena", "Weber.", "Following", "receipt", "of", "your", "complete", "response", "to", "these", "issues,", "we", "will", "notify", "you", "of", "our", "decision", "within", "30", "days.", "424", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-INDNDA-01577085", "in", "MDL", "on", "01/31/13", "Source:", "https://www.induptrygg-ooooits.ucsf.edu/docs/xyjf0226" ]

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{ "match_score": 0.9285714336734691, "matched_text": "Ms. Jena Weber", "start": 1714, "text": "Ms. Jens Weber" }

{ "de": "Welche Erstattung für TPNA-Arzneimittel wird in der Regel gewährt?", "en": "Which reimbursement for TPNA pharmaceutical products is generally given?", "es": "¿Qué reembolso para los productos farmacéuticos TPNA se da generalmente?", "fr": "Quel remboursement pour les produits pharmaceutiques TPNA est généralement accordé?", "it": "Quale rimborso per i prodotti farmaceutici TPNA è generalmente dato?" }

[ "Medicare and Medicaid" ]

[ "3.", "Reports", "to", "any", "third", "party,", "including,", "but", "not", "limited", "to,", "RedBook,", "First", "Data", "Bank,", "Blue", "Book,", "Medi-Span,", "or", "other", "price", "reporting", "service,", "regarding", "prices", "for", "TPNA", "products;", "4.", "Communications", "with", "RedBook,", "First", "Data", "Bank,", "Blue", "Book,", "Medi-Span,", "or", "other", "pricing", "reporting", "services,", "regarding", "prices", "for", "TPNA", "products;", "5.", "WAC", "and", "AWP", "generally;", "6.", "Medicare", "and", "Medicaid", "reimbursement", "for", "TPNA", "pharmaceutical", "products", "generally;", "7.", "Calculation", "and", "reporting", "of", "Average", "Manufacturer", "Price", "and", "Best", "Price", "for", "TPNA", "products,", "as", "may", "be", "required", "by", "federal", "and", "state", "laws", "and", "regulations;", "8.", "Communications", "with", "any", "state", "or", "federal", "governmental", "agency", "regarding", "TPNA's", "participation", "in", "the", "Medicaid", "program;", "9.", "Invoices,", "internal", "sales", "projections,", "and", "profit", "statements", "that", "indicate", "the", "price", "TPNA", "paid", "for", "its", "products", "and", "the", "profits", "IPNA", "made", "based", "upon", "sales", "of", "these", "products;", "10.", "Meetings", "at", "which", "sales,", "marketing,", "and", "pricing", "decisions", "were", "discussed;", "11.", "Communications", "with", "providers,", "if", "any,", "relating", "to", "the", "use", "of", "the", "terms", "\"spread\"", "or", "\"profit\"", "in", "the", "context", "of", "the", "sale", "or", "marketing", "of", "TPNA", "products;", "12.", "Marketing", "materials", "(including", "proposed", "materials),", "if", "any,", "relating", "to", "the", "cost", "and", "\"spread\"", "for", "TPNA", "products;", "13.", "Provision", "of", "free", "samples", "or", "nominally", "priced", "TPNA", "products", "to", "any", "providers;", "and", "14.", "Educational", "grants", "regarding", "TPNA", "products;", "These", "requirements", "are", "related", "to", "all", "TPNA", "marketed", "products.", "Each", "Takeda", "Employee", "or", "Contractor", "shall", "create", "an", "Outlook", "Folder", "entitled", "\"AWP\"", "beneath", "the", "\"Legal", "Hold\"", "folder", "provided", "as", "part", "of", "the", "implementation", "of", "CORP-B-019", "\"E-mail", "Management", "and", "Retention.\"", "Contact", "the", "Help", "Desk", "if", "your", "Outlook", "file", "folder", "structure", "does", "not", "contain", "a", "\"Legal", "Hold\"", "folder.", "This", "means", "that", "all", "documents,", "materials,", "and", "computer", "files", "(including", "e-mails,", "word", "processing", "documents,", "slides,", "etc.)", "falling", "into", "this", "category", "must", "continue", "to", "be", "maintained", "until", "you", "are", "informed", "otherwise,", "regardless", "of", "the", "specified", "record", "retention", "period", "that", "would", "apply", "to", "such", "materials", "under", "Takeda's", "current", "Records", "Retention", "Schedules", "and", "program.", "You", "are", "reminded", "that", "you", "must", "follow", "the", "requirements", "of", "BOP,", "CORP-B-019", "\"E-mail", "Management", "and", "Retention\"", "for", "the", "retention", "of", "electronic", "materials,", "and", "the", "\"Best", "Practices", "For", "The", "Physical", "And", "Electronic", "Storage", "Of", "Materials", "That", "Must", "Be", "Retained", "For", "Legal", "Reasons....\"", "IN", "ALL", "CASES,", "THE", "FOLLOWING", "INSTRUCTIONS", "APPLY", "TO", "DOCUMENTS,", "MATERIALS,", "INFORMATION,", "AND", "THINGS,", "IN", "HARD", "COPY", "OR", "ELECTRONIC", "FORMAT,", "THAT", "ARE", "REQUIRED", "TO", "BE", "RETAINED", "PURSUANT", "TO", "THIS", "LEGAL", "HOLD.", "Last", "printed", "11/30/2012", "4:28:00", "AM", "20122830-042845", "doc", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RIM30b6-00000665", "Source:", "https://www.indup5316-@0003ts.ucsf.edu/docs/frjf0226" ]

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{ "match_score": 1, "matched_text": "Medicare and Medicaid", "start": 353, "text": "Medicare and Medicaid" }

{ "de": "Wie lautet die Bezeichnung von Alfonso T. Perez, M.D.?", "en": "What is the designation of Alfonso T. Perez, M.D.?", "es": "¿Cuál es la designación de Alfonso T. Pérez, M.D.?", "fr": "Quelle est la désignation d'Alfonso T. Perez, M.D.?", "it": "Qual è la designazione di Alfonso T. Perez, MD?" }

[ "Vice President, Clinical Research" ]

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{ "match_score": 1, "matched_text": "Vice President, Clinical Research", "start": 2965, "text": "Vice President, Clinical Research" }

{ "de": "Von wem wurde diese Vereinbarung vereinbart und angenommen?", "en": "By whom was this agreement Agreed and Accepted?", "es": "¿Por quién se acordó y aceptó este acuerdo?", "fr": "Par qui cet accord a-t-il été approuvé et accepté?", "it": "Da chi è stato accettato questo accordo?" }

[ "Richard A. Rudick, M.D.", "Richard A. Rudick, M.D. Chairman, Division of Clinical Research", "Richard A. Rudick" ]

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{ "match_score": 1, "matched_text": "Richard A. Rudick, M.D.", "start": 2999, "text": "Richard A. Rudick, M.D." }

{ "de": "Was ist die vollständige Form von FAR?", "en": "What is the full form of FAR?", "es": "¿Cuál es la forma completa de FAR?", "fr": "Quelle est la forme complète de FAR?", "it": "Qual è la forma completa di FAR?" }

[ "Federal Acquisitions Regulation" ]

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{ "match_score": 1, "matched_text": "Federal Acquisitions Regulation", "start": 850, "text": "Federal Acquisitions Regulation" }

{ "de": "Wie lautet die oben geschriebene Nummer TAK-INDNDA-01577086?", "en": "What is the number written above TAK-INDNDA-01577086?", "es": "¿Cuál es el número escrito arriba de TAK-INDNDA-01577086?", "fr": "Quel est le numéro écrit ci-dessus TAK-INDNDA-01577086?", "it": "Qual è il numero scritto sopra TAK-INDNDA-01577086?" }

[ "425" ]

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{ "match_score": 1, "matched_text": "425", "start": 876, "text": "425" }

{ "de": "Wie lautet die Kontaktnummer von Frau Jena Weber, Regulatory Project Manager?", "en": "What is the contact number of Ms. Jena Weber, Regulatory Project Manager?", "es": "¿Cuál es el número de contacto de la Sra. Jena Weber, Directora del Proyecto Regulador?", "fr": "Quel est le numéro de contact de Mme Jena Weber, gestionnaire de projet de réglementation?", "it": "Qual è il numero di contatto della Sig.ra Jena Weber, Responsabile del Progetto Regolatore?" }

[ "301-827-6422" ]

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{ "match_score": 1, "matched_text": "301-827-6422", "start": 660, "text": "301-827-6422" }

{ "de": "Was ist die vollständige Form der ODE?", "en": "What is the full form of ODE?", "es": "¿Cuál es la forma completa de la ODE?", "fr": "Quelle est la forme complète de l'ODE?", "it": "Qual è la forma completa di ODE?" }

[ "Office of Drug Evaluation" ]

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{ "match_score": 1, "matched_text": "Office of Drug Evaluation", "start": 414, "text": "Office of Drug Evaluation" }

{ "de": "Was steht oben auf Seite 2 oben?", "en": "What is written above Page 2 on the top?", "es": "¿Qué está escrito encima de la página 2 en la parte superior?", "fr": "Qu'est-ce qui est écrit en haut de la page 2?", "it": "Cosa c'è scritto sopra Pagina 2 in alto?" }

[ "IND 33, 729" ]

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{ "match_score": 0.900000009999999, "matched_text": "IND 33,729", "start": 0, "text": "IND 33, 729" }

{ "de": "Was ist die im Buchstaben erwähnte Einheit?", "en": "what is the unit mentioned in the letter ?", "es": "¿Cuál es la unidad mencionada en la carta?", "fr": "Quelle est l'unité mentionnée dans la lettre?", "it": "che cos'è l'unità menzionata nella lettera?" }

[ "7200" ]

[ "FROM", "THE", "DESK", "OF:", "Timothy", "J.", "Gumbleton", "UNIT:", "7200", "BLOG", ":", "24-1", "EXT:", "5-7054", "PJ", "Daniels", "LSolanoff", "DATE:", "9/23/42", "PL", "Ruppel", "L", "Twelch", "Attached", "is", "a", "cozy", "of", "the", "letter", "from", "Dn,", "Mitchell", "to'", "DA.", "Matsozawa", "It", "was", "faxed", "today", ",", "Do.", "Mitchell", "added", "one", "sentence", "ox", "the", "bottom", "of", "Paragraph", "3.", "He", "said", "that", "me", "further", "contact", "with", "Takecia", "Should", "be", "made", "until", "we", "receive", "a", "reply", "from", "them.", "Please", "call", "if", "you", "have", "any", "questions", ".", "Upjohn", "DALY", "18", "CONFIDENTIAL", "-", "SUBJECT", "UPJ-0065602DEI", "Source:", "https://www.indupodscoo09nts.ucsf.edu/docs/zsjf0226" ]

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{ "match_score": 1, "matched_text": "7200", "start": 45, "text": "7200" }

{ "de": "Name der ersten Person in der To-Liste?", "en": "Name of the first person in the To list?", "es": "¿Nombre de la primera persona en la lista To?", "fr": "Nom de la première personne sur la liste To?", "it": "Nome della prima persona nell'elenco To?" }

[ "PJ Daniels", "pj Daniels" ]

[ "FROM", "THE", "DESK", "OF:", "Timothy", "J.", "Gumbleton", "UNIT:", "7200", "BLOG", ":", "24-1", "EXT:", "5-7054", "PJ", "Daniels", "LSolanoff", "DATE:", "9/23/42", "PL", "Ruppel", "L", "Twelch", "Attached", "is", "a", "cozy", "of", "the", "letter", "from", "Dn,", "Mitchell", "to'", "DA.", "Matsozawa", "It", "was", "faxed", "today", ",", "Do.", "Mitchell", "added", "one", "sentence", "ox", "the", "bottom", "of", "Paragraph", "3.", "He", "said", "that", "me", "further", "contact", "with", "Takecia", "Should", "be", "made", "until", "we", "receive", "a", "reply", "from", "them.", "Please", "call", "if", "you", "have", "any", "questions", ".", "Upjohn", "DALY", "18", "CONFIDENTIAL", "-", "SUBJECT", "UPJ-0065602DEI", "Source:", "https://www.indupodscoo09nts.ucsf.edu/docs/zsjf0226" ]

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{ "match_score": 1, "matched_text": "PJ Daniels", "start": 74, "text": "PJ Daniels" }

{ "de": "von wessen Schreibtisch ist dieser Brief geschrieben?", "en": "from whose desk this letter is written ?", "es": "¿De quién está escrita esta carta?", "fr": "de quel bureau cette lettre est-elle écrite?", "it": "da quale scrivania questa lettera è scritta?" }

[ "Timothy J. Gumbleton", "timothy J Gumbleton" ]

[ "FROM", "THE", "DESK", "OF:", "Timothy", "J.", "Gumbleton", "UNIT:", "7200", "BLOG", ":", "24-1", "EXT:", "5-7054", "PJ", "Daniels", "LSolanoff", "DATE:", "9/23/42", "PL", "Ruppel", "L", "Twelch", "Attached", "is", "a", "cozy", "of", "the", "letter", "from", "Dn,", "Mitchell", "to'", "DA.", "Matsozawa", "It", "was", "faxed", "today", ",", "Do.", "Mitchell", "added", "one", "sentence", "ox", "the", "bottom", "of", "Paragraph", "3.", "He", "said", "that", "me", "further", "contact", "with", "Takecia", "Should", "be", "made", "until", "we", "receive", "a", "reply", "from", "them.", "Please", "call", "if", "you", "have", "any", "questions", ".", "Upjohn", "DALY", "18", "CONFIDENTIAL", "-", "SUBJECT", "UPJ-0065602DEI", "Source:", "https://www.indupodscoo09nts.ucsf.edu/docs/zsjf0226" ]

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{ "match_score": 1, "matched_text": "Timothy J. Gumbleton", "start": 18, "text": "Timothy J. Gumbleton" }

{ "de": "Wessen Kopie ist beigefügt?", "en": "Whose letter's copy is attached?", "es": "¿La copia de la carta de quién está adjunta?", "fr": "La copie de la lettre de qui est jointe?", "it": "A chi e' allegata la copia della lettera?" }

[ "DR. Mitchell", "Dr. Mitchell" ]

[ "FROM", "THE", "DESK", "OF:", "Timothy", "J.", "Gumbleton", "UNIT:", "7200", "BLOG", ":", "24-1", "EXT:", "5-7054", "PJ", "Daniels", "LSolanoff", "DATE:", "9/23/42", "PL", "Ruppel", "L", "Twelch", "Attached", "is", "a", "cozy", "of", "the", "letter", "from", "Dn,", "Mitchell", "to'", "DA.", "Matsozawa", "It", "was", "faxed", "today", ",", "Do.", "Mitchell", "added", "one", "sentence", "ox", "the", "bottom", "of", "Paragraph", "3.", "He", "said", "that", "me", "further", "contact", "with", "Takecia", "Should", "be", "made", "until", "we", "receive", "a", "reply", "from", "them.", "Please", "call", "if", "you", "have", "any", "questions", ".", "Upjohn", "DALY", "18", "CONFIDENTIAL", "-", "SUBJECT", "UPJ-0065602DEI", "Source:", "https://www.indupodscoo09nts.ucsf.edu/docs/zsjf0226" ]

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{ "match_score": 0.9166666736111105, "matched_text": "Do. Mitchell", "start": 218, "text": "DR. Mitchell" }

{ "de": "Wie lautet das erwähnte Datum?", "en": "what is the date mentioned ?", "es": "¿Cuál es la fecha mencionada?", "fr": "Quelle est la date mentionnée?", "it": "Qual è la data indicata?" }

[ "February 6, 1996", "february 6 , 1996" ]

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{ "match_score": 1, "matched_text": "February 6, 1996", "start": 65, "text": "February 6, 1996" }

{ "de": "an wen dieser Brief geschrieben wird?", "en": "to whom this letter is written ?", "es": "¿A quién está escrita esta carta?", "fr": "à qui cette lettre est-elle écrite?", "it": "a chi è scritta questa lettera?" }

[ "Dr. K. KItazawa", "Dr . k. Kitazawa" ]

[ "..", "Encl.", "2", "Draft", "2", "/", "1", "1", "TAKEDA", "INTERNATIONAL", "COMMUNICATION", "Date", "February", "6,", "1996", "To", "Dr.", "K.", "Kitazawa", "General", "Manager", "International", "Development", "From", "T.", "Suzuki", "Senior", "Research", "Head", "Drug", "Safety", "Research", "Laboratories", "Subject", "A", "Prompt", "Report", "for", "Interim", "Results", "of", "AD-4833", "2Y", "Rat", "&", "Mouse", "Studies", "We", "are", "performing", "two-your", "carcinogenicity", "studies", "in", "rats", "and", "mice", "at", "MPI", "(formerly;", "[RDC)", "Research", "Labs.", "Pathological", "examinations", "of", "these", "studies", "have", "almost", "finished", "recently.", ":", "In", "the", "rat", "study,", "a", "treatment-related", "increase", "in", "incidence", "of", "transitional", "cell", "tumors", "in", "the", "winary", "bladder", "was", "seen.", "1)", "Rat", "study", "Sixty", "Sprague-Dawley", "Cri:CD\"", "BR", "rats/sex/group", "were", "administered", "AD-4833", "(HCI)", "at", "doses", "of", "1,", "4,", "8,", "16", "and", "63mg/kg/day", "for", "males", "and", ",", "4,", "16", "and", "63mg/kg/day", "for", "females.", "The", "incidence", "of", "transitional", "cell", "benign", "tumor", "and/or", "transitional", "cell", "carcinoma", "in", "the", "urinary", "bladder", "was", "increased", "in", "males", "receiving", "4mg/ke/day", "or", "more.", "In", "females,", "transitional", "call", "benign", "tumor", "in", "the", "same", "organ", "was", "seen", "in", "each", "one", "animal", "receiving", "1,", "4", "and", "16mig/kg/day.", "There", "is", "no", "treatment-", "related", "increase", "in", "incidence", "of", "tumors", "in", "any", "other", "organs.", "2)", "Mouse", "study", "Sixty", "CHI:CD", "(ICR)", "BR", "VAF/Plus\"", "mice/sex/group", "were", "administered", "AD-4833", "(HCI)", "at", "doses", "of", "3,", "10.", "30", "and", "100me/ke/day.", "There", "is", "no", "treatment-related", "increase", "in", "incidence", "of", "tumors", "in", "any", "organs.", "There", "is", "no", "treatment-related", "increase", "in", "incidence", "of", "tumors", "in", "any", "organs", "in", "2-year", "mouse", "and", "one", "year", "dog", "and", "monkey", "study.", "Thus,", "it", "is", "supposed", "that", "increased", "tumors", "in", "urinary", "bladder", "might", "be", "species", "specific.", ".", "...", "Tsuyoshi", "Suzuki,", "M.", "S.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-COHENS-00006201", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.induBQ178-2090nits.ucsf.edu/docs/hmjf0226" ]

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{ "match_score": 0.9333333377777775, "matched_text": "Dr. K. Kitazawa", "start": 85, "text": "Dr. K. KItazawa" }

{ "de": "Dieser Brief wird von wem geschrieben?", "en": "this letter is written by whom ?", "es": "¿Esta carta está escrita por quién?", "fr": "cette lettre est écrite par qui?", "it": "Questa lettera è scritta da chi?" }

[ "T. Suzuki", "Tsuyoshi Suzuki , M S ." ]

[ "..", "Encl.", "2", "Draft", "2", "/", "1", "1", "TAKEDA", "INTERNATIONAL", "COMMUNICATION", "Date", "February", "6,", "1996", "To", "Dr.", "K.", "Kitazawa", "General", "Manager", "International", "Development", "From", "T.", "Suzuki", "Senior", "Research", "Head", "Drug", "Safety", "Research", "Laboratories", "Subject", "A", "Prompt", "Report", "for", "Interim", "Results", "of", "AD-4833", "2Y", "Rat", "&", "Mouse", "Studies", "We", "are", "performing", "two-your", "carcinogenicity", "studies", "in", "rats", "and", "mice", "at", "MPI", "(formerly;", "[RDC)", "Research", "Labs.", "Pathological", "examinations", "of", "these", "studies", "have", "almost", "finished", "recently.", ":", "In", "the", "rat", "study,", "a", "treatment-related", "increase", "in", "incidence", "of", "transitional", "cell", "tumors", "in", "the", "winary", "bladder", "was", "seen.", "1)", "Rat", "study", "Sixty", "Sprague-Dawley", "Cri:CD\"", "BR", "rats/sex/group", "were", "administered", "AD-4833", "(HCI)", "at", "doses", "of", "1,", "4,", "8,", "16", "and", "63mg/kg/day", "for", "males", "and", ",", "4,", "16", "and", "63mg/kg/day", "for", "females.", "The", "incidence", "of", "transitional", "cell", "benign", "tumor", "and/or", "transitional", "cell", "carcinoma", "in", "the", "urinary", "bladder", "was", "increased", "in", "males", "receiving", "4mg/ke/day", "or", "more.", "In", "females,", "transitional", "call", "benign", "tumor", "in", "the", "same", "organ", "was", "seen", "in", "each", "one", "animal", "receiving", "1,", "4", "and", "16mig/kg/day.", "There", "is", "no", "treatment-", "related", "increase", "in", "incidence", "of", "tumors", "in", "any", "other", "organs.", "2)", "Mouse", "study", "Sixty", "CHI:CD", "(ICR)", "BR", "VAF/Plus\"", "mice/sex/group", "were", "administered", "AD-4833", "(HCI)", "at", "doses", "of", "3,", "10.", "30", "and", "100me/ke/day.", "There", "is", "no", "treatment-related", "increase", "in", "incidence", "of", "tumors", "in", "any", "organs.", "There", "is", "no", "treatment-related", "increase", "in", "incidence", "of", "tumors", "in", "any", "organs", "in", "2-year", "mouse", "and", "one", "year", "dog", "and", "monkey", "study.", "Thus,", "it", "is", "supposed", "that", "increased", "tumors", "in", "urinary", "bladder", "might", "be", "species", "specific.", ".", "...", "Tsuyoshi", "Suzuki,", "M.", "S.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-COHENS-00006201", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.induBQ178-2090nits.ucsf.edu/docs/hmjf0226" ]

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{ "match_score": 1, "matched_text": "T. Suzuki", "start": 148, "text": "T. Suzuki" }

{ "de": "Mit welchem Labor ist T. Suzuki verbunden?", "en": "Which laboratory is T. Suzuki associated with ?", "es": "¿Con qué laboratorio está asociado T. Suzuki?", "fr": "Quel laboratoire est associé à T. Suzuki?", "it": "Quale laboratorio è associato a T. Suzuki?" }

[ "Drug Safety Research Laboratories", "drug safety research laboratories ." ]

[ "..", "Encl.", "2", "Draft", "2", "/", "1", "1", "TAKEDA", "INTERNATIONAL", "COMMUNICATION", "Date", "February", "6,", "1996", "To", "Dr.", "K.", "Kitazawa", "General", "Manager", "International", "Development", "From", "T.", "Suzuki", "Senior", "Research", "Head", "Drug", "Safety", "Research", "Laboratories", "Subject", "A", "Prompt", "Report", "for", "Interim", "Results", "of", "AD-4833", "2Y", "Rat", "&", "Mouse", "Studies", "We", "are", "performing", "two-your", "carcinogenicity", "studies", "in", "rats", "and", "mice", "at", "MPI", "(formerly;", "[RDC)", "Research", "Labs.", "Pathological", "examinations", "of", "these", "studies", "have", "almost", "finished", "recently.", ":", "In", "the", "rat", "study,", "a", "treatment-related", "increase", "in", "incidence", "of", "transitional", "cell", "tumors", "in", "the", "winary", "bladder", "was", "seen.", "1)", "Rat", "study", "Sixty", "Sprague-Dawley", "Cri:CD\"", "BR", "rats/sex/group", "were", "administered", "AD-4833", "(HCI)", "at", "doses", "of", "1,", "4,", "8,", "16", "and", "63mg/kg/day", "for", "males", "and", ",", "4,", "16", "and", "63mg/kg/day", "for", "females.", "The", "incidence", "of", "transitional", "cell", "benign", "tumor", "and/or", "transitional", "cell", "carcinoma", "in", "the", "urinary", "bladder", "was", "increased", "in", "males", "receiving", "4mg/ke/day", "or", "more.", "In", "females,", "transitional", "call", "benign", "tumor", "in", "the", "same", "organ", "was", "seen", "in", "each", "one", "animal", "receiving", "1,", "4", "and", "16mig/kg/day.", "There", "is", "no", "treatment-", "related", "increase", "in", "incidence", "of", "tumors", "in", "any", "other", "organs.", "2)", "Mouse", "study", "Sixty", "CHI:CD", "(ICR)", "BR", "VAF/Plus\"", "mice/sex/group", "were", "administered", "AD-4833", "(HCI)", "at", "doses", "of", "3,", "10.", "30", "and", "100me/ke/day.", "There", "is", "no", "treatment-related", "increase", "in", "incidence", "of", "tumors", "in", "any", "organs.", "There", "is", "no", "treatment-related", "increase", "in", "incidence", "of", "tumors", "in", "any", "organs", "in", "2-year", "mouse", "and", "one", "year", "dog", "and", "monkey", "study.", "Thus,", "it", "is", "supposed", "that", "increased", "tumors", "in", "urinary", "bladder", "might", "be", "species", "specific.", ".", "...", "Tsuyoshi", "Suzuki,", "M.", "S.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-COHENS-00006201", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.induBQ178-2090nits.ucsf.edu/docs/hmjf0226" ]

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{ "match_score": 1, "matched_text": "Drug Safety Research Laboratories", "start": 179, "text": "Drug Safety Research Laboratories" }

{ "de": "Wie lautet das im Schreiben genannte Datum?", "en": "what is the date mentioned in the letter", "es": "¿Cuál es la fecha mencionada en la carta", "fr": "quelle est la date mentionnée dans la lettre", "it": "qual è la data indicata nella lettera" }

[ "August 8, 2002", "august 8 , 2002" ]

[ "08/07/2002", "18:46", "06", "6204", "2244", "2002", "08/08", "21:", "49", "FAX", "06", "6204", "2244", "TAKEDA", "DEVELOP", "DIVISION", "001/006", "116", "TAKEDA", "CHEMICAL", "INDUSTRIES,", "LTD.", "Pharmaceutical", "Development", "Division", "1-1,", "Doshomachi", "4-chome,", "Chuo-ku", "OSAKA", "540-8645,", "Japan", "Phone", "+81-6-6204-2259", "/", "Facsimile", "+81-6-6204-2244", "Dr.", "Claire", "Thom", "August", "8,", "2002", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "Ref:", "TPNA-TS-020808", "475", "Half", "Day", "Road,", "Suite", "500", "Lincolnshire,", "IL", "60069,", "USA", "CC", "Mr.", "S.", "Hamanaka", "Urgent", "Re:", "ACTOS", "Pages(", "Including", "Cover)", ":", "6", "Dear", "Dr.", "Thom,", "We", "faxed", "you", "three", "documents", "regarding", "Actos.", "1.", "Comments", "about", "a", "contact", "with", "NN", "2.", "Action", "plan", "for", "NN", "issue", "3.", "Discussion", "points", "to", "address", "the", "three", "key", "issues", "raised", "by", "the", "FDA", "If", "you", "have", "any", "questions,", "please", "do", "not", "hesitate", "to", "contact", "us.", "Best", "wishes,", "K.", "Saito", "Katsuhisa", "Saito", "Dept.", "Strategic", "Development", "Pharmaceutical", "Development", "Division", "Takeda", "Chemical", "Industries,", "LTD.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019744", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupbodomoooonts.ucsf.edu/docs/pljf0226" ]

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{ "match_score": 1, "matched_text": "August 8, 2002", "start": 291, "text": "August 8, 2002" }

{ "de": "Wie heißt die Branche hier?", "en": "What is the name of the industry given here?", "es": "¿Cuál es el nombre de la industria que se da aquí?", "fr": "Quel est le nom de l'industrie ici?", "it": "Qual è il nome del settore qui indicato?" }

[ "Takeda chemical industries, LTD .", "TAKEDA CHEMICAL INDUSTRIES, LTD." ]

[ "08/07/2002", "18:46", "06", "6204", "2244", "2002", "08/08", "21:", "49", "FAX", "06", "6204", "2244", "TAKEDA", "DEVELOP", "DIVISION", "001/006", "116", "TAKEDA", "CHEMICAL", "INDUSTRIES,", "LTD.", "Pharmaceutical", "Development", "Division", "1-1,", "Doshomachi", "4-chome,", "Chuo-ku", "OSAKA", "540-8645,", "Japan", "Phone", "+81-6-6204-2259", "/", "Facsimile", "+81-6-6204-2244", "Dr.", "Claire", "Thom", "August", "8,", "2002", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "Ref:", "TPNA-TS-020808", "475", "Half", "Day", "Road,", "Suite", "500", "Lincolnshire,", "IL", "60069,", "USA", "CC", "Mr.", "S.", "Hamanaka", "Urgent", "Re:", "ACTOS", "Pages(", "Including", "Cover)", ":", "6", "Dear", "Dr.", "Thom,", "We", "faxed", "you", "three", "documents", "regarding", "Actos.", "1.", "Comments", "about", "a", "contact", "with", "NN", "2.", "Action", "plan", "for", "NN", "issue", "3.", "Discussion", "points", "to", "address", "the", "three", "key", "issues", "raised", "by", "the", "FDA", "If", "you", "have", "any", "questions,", "please", "do", "not", "hesitate", "to", "contact", "us.", "Best", "wishes,", "K.", "Saito", "Katsuhisa", "Saito", "Dept.", "Strategic", "Development", "Pharmaceutical", "Development", "Division", "Takeda", "Chemical", "Industries,", "LTD.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019744", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupbodomoooonts.ucsf.edu/docs/pljf0226" ]

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{ "match_score": 0.9062500029296874, "matched_text": "Takeda Chemical Industries, LTD.", "start": 853, "text": "Takeda chemical industries, LTD ." }

{ "de": "an wen dieser Brief geschrieben wird?", "en": "to whom this letter is written ?", "es": "¿A quién está escrita esta carta?", "fr": "à qui cette lettre est-elle écrite?", "it": "a chi è scritta questa lettera?" }

[ "Dr. Claire Thom", "Dr. Thom" ]

[ "08/07/2002", "18:46", "06", "6204", "2244", "2002", "08/08", "21:", "49", "FAX", "06", "6204", "2244", "TAKEDA", "DEVELOP", "DIVISION", "001/006", "116", "TAKEDA", "CHEMICAL", "INDUSTRIES,", "LTD.", "Pharmaceutical", "Development", "Division", "1-1,", "Doshomachi", "4-chome,", "Chuo-ku", "OSAKA", "540-8645,", "Japan", "Phone", "+81-6-6204-2259", "/", "Facsimile", "+81-6-6204-2244", "Dr.", "Claire", "Thom", "August", "8,", "2002", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "Ref:", "TPNA-TS-020808", "475", "Half", "Day", "Road,", "Suite", "500", "Lincolnshire,", "IL", "60069,", "USA", "CC", "Mr.", "S.", "Hamanaka", "Urgent", "Re:", "ACTOS", "Pages(", "Including", "Cover)", ":", "6", "Dear", "Dr.", "Thom,", "We", "faxed", "you", "three", "documents", "regarding", "Actos.", "1.", "Comments", "about", "a", "contact", "with", "NN", "2.", "Action", "plan", "for", "NN", "issue", "3.", "Discussion", "points", "to", "address", "the", "three", "key", "issues", "raised", "by", "the", "FDA", "If", "you", "have", "any", "questions,", "please", "do", "not", "hesitate", "to", "contact", "us.", "Best", "wishes,", "K.", "Saito", "Katsuhisa", "Saito", "Dept.", "Strategic", "Development", "Pharmaceutical", "Development", "Division", "Takeda", "Chemical", "Industries,", "LTD.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019744", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupbodomoooonts.ucsf.edu/docs/pljf0226" ]

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{ "match_score": 1, "matched_text": "Dr. Claire Thom", "start": 275, "text": "Dr. Claire Thom" }

{ "de": "was ist der Name in CC erwähnt", "en": "what is the name mentioned in CC", "es": "cual es el nombre mencionado en CC", "fr": "quel est le nom mentionné dans CC", "it": "qual è il nome menzionato in CC" }

[ "Mr. S. Hamanaka", "Mr . S . Hamanaka" ]

[ "08/07/2002", "18:46", "06", "6204", "2244", "2002", "08/08", "21:", "49", "FAX", "06", "6204", "2244", "TAKEDA", "DEVELOP", "DIVISION", "001/006", "116", "TAKEDA", "CHEMICAL", "INDUSTRIES,", "LTD.", "Pharmaceutical", "Development", "Division", "1-1,", "Doshomachi", "4-chome,", "Chuo-ku", "OSAKA", "540-8645,", "Japan", "Phone", "+81-6-6204-2259", "/", "Facsimile", "+81-6-6204-2244", "Dr.", "Claire", "Thom", "August", "8,", "2002", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "Ref:", "TPNA-TS-020808", "475", "Half", "Day", "Road,", "Suite", "500", "Lincolnshire,", "IL", "60069,", "USA", "CC", "Mr.", "S.", "Hamanaka", "Urgent", "Re:", "ACTOS", "Pages(", "Including", "Cover)", ":", "6", "Dear", "Dr.", "Thom,", "We", "faxed", "you", "three", "documents", "regarding", "Actos.", "1.", "Comments", "about", "a", "contact", "with", "NN", "2.", "Action", "plan", "for", "NN", "issue", "3.", "Discussion", "points", "to", "address", "the", "three", "key", "issues", "raised", "by", "the", "FDA", "If", "you", "have", "any", "questions,", "please", "do", "not", "hesitate", "to", "contact", "us.", "Best", "wishes,", "K.", "Saito", "Katsuhisa", "Saito", "Dept.", "Strategic", "Development", "Pharmaceutical", "Development", "Division", "Takeda", "Chemical", "Industries,", "LTD.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019744", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupbodomoooonts.ucsf.edu/docs/pljf0226" ]

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{ "match_score": 1, "matched_text": "Mr. S. Hamanaka", "start": 429, "text": "Mr. S. Hamanaka" }

{ "de": "Wer hat diesen Brief geschickt?", "en": "Who sent this letter?", "es": "¿Quién envió esta carta?", "fr": "Qui a envoyé cette lettre?", "it": "Chi ha mandato questa lettera?" }

[ "Katsuhisa Saito", "katsuhisa saito" ]

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{ "match_score": 1, "matched_text": "Katsuhisa Saito", "start": 773, "text": "Katsuhisa Saito" }

{ "de": "was ist Ref: Code erwähnt?", "en": "what is Ref: code mentioned ?", "es": "¿Qué es Ref: código mencionado?", "fr": "Qu'est-ce que Ref: code mentionné?", "it": "che cosa è Ref: codice menzionato?" }

[ "TPNA-TS-020808" ]

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{ "match_score": 1, "matched_text": "TPNA-TS-020808", "start": 354, "text": "TPNA-TS-020808" }

{ "de": "Was ist der im Dokument erwähnte Veranstaltungsort?", "en": "What is the venue mentioned in the document?", "es": "¿Cuál es el lugar mencionado en el documento?", "fr": "Quel est le lieu mentionné dans le document?", "it": "Qual è la sede indicata nel documento?" }

[ "TPNA, Chicago" ]

[ "08/07/2002", "18:47", "06", "6204", "2244", ".", "2002'", "08/08", "21:50", "FAX", "06", "6204", "2244", "TAKEDA", "DEVELOP", "DIVISION", "2", "006/006", "6", "/", "6", "Discussion", "points", "to", "address", "the", "three", "key", "issues", "raised", "by", "the", "FDA", "Date:", "Monday,", "12", "and", "Tuesday,", "13", "August", "2002", "Venue:", "TPNA,", "Chicago", "ISSUES", "1.", "They", "requested", "us", "to", "propose", "a", "method", "by", "which", "to", "monitor", "bladder", "toxicity", "in", "patients", "in", "our", "long", "term", "phase", "4", "clinical", "trials", "(long", "term", "was", "defined", "as", "at", "least", "1", "year)", "2.", "They", "indicated", "an", "inclination", "to", "rescind", "the", "written", "request", "for", "pediatric", "exclusivity", "based", "on", "their", "concern", "about", "bladder", "tumors.", "3.", "They", "requested", "us", "to", "give", "some", "consideration", "to", "a", "label", "change", "that", "would", "reflect", "possible", "relatedness", "of", "tumor", "formation", "to", "mechanism", "(dual", "PPAR", "agonist)", "instead", "of", "the", "current", "language", "(\"The", "relationship", "of", "these", "findings", "in", "male", "rats", "to", "humans", "is", "unclear.\")", "DISCUSSION", "POINTS", "to", "briefly", "review", "the", "toxicity", "study", "results", "of", "pioglitazone,", "particularly", "carcinogenicity", "studies", "b.", "to", "summarise", "discussions", "with", "the", "CPMP", "to", "submit", "literature", "suggesting", "that", "pioglitazone", "suppresses", "the", "cell", "growth,", "particularly", "urinary", "bladder", "cell", "1.", "to", "perform", "an", "in-vitro", "study", "to", "evaluate", "the", "cell", "growth", "and", "cell", "growth", "inhibition", "with", "piogliatzone", "e.", "to", "investigate", "carbonic", "anhydrase", "inhibiting", "activity", "of", "NN622,", "pioglitazone", "and", "rosiglitazone", "f.", "to", "compare", "PPAR", "agonists", "in", "terms", "of", "alpha", "and", "gamma", "activities", "g.", "to", "differentiate", "between", "glitazones", "and", "glitazars", "h.", "to", "consult", "with", "non-clinical", "external", "experts", "for", "their", "expertise", "i.", "to", "find", "a", "rationale", "for", "not", "doing", "clinical", "monitoring", "j-", "a", "monotoring", "method", "k", ".", "a", "case", "control", "study", "1.", "a", "pharmacoepidemiology", "study", "m.", "to", "submit", "a", "report", "from", "a", "Japanese", "follow", "up", "study", "for", "pioglitazone", "n.", "to", "assess", "cases", "from", "database", "search", "for", "pioglitazone", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019749", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupbodocoboosts.ucsf.edu/docs/pljf0226" ]

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{ "match_score": 1, "matched_text": "TPNA, Chicago", "start": 227, "text": "TPNA, Chicago" }

{ "de": "Wie lautet das im Dokument genannte Datum?", "en": "What is the date mentioned in the document?", "es": "¿Cuál es la fecha mencionada en el documento?", "fr": "Quelle est la date mentionnée dans le document?", "it": "Qual è la data indicata nel documento?" }

[ "Monday, 12 and Tuesday, 13 August 2002" ]

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{ "match_score": 1, "matched_text": "Monday, 12 and Tuesday, 13 August 2002", "start": 181, "text": "Monday, 12 and Tuesday, 13 August 2002" }

{ "de": "Wie lautet die Faxnummer, die oben im Brief erwähnt wird?", "en": "what is the fax number mentioned in the letter at the top?", "es": "¿Cuál es el número de fax mencionado en la carta en la parte superior?", "fr": "Quel est le numéro de télécopieur mentionné dans la lettre en haut?", "it": "Qual è il numero di fax menzionato nella lettera in alto?" }

[ "06 6204 2244" ]

[ "08/07/2002", "18:47", "06", "6204", "2244", ".", "2002'", "08/08", "21:50", "FAX", "06", "6204", "2244", "TAKEDA", "DEVELOP", "DIVISION", "2", "006/006", "6", "/", "6", "Discussion", "points", "to", "address", "the", "three", "key", "issues", "raised", "by", "the", "FDA", "Date:", "Monday,", "12", "and", "Tuesday,", "13", "August", "2002", "Venue:", "TPNA,", "Chicago", "ISSUES", "1.", "They", "requested", "us", "to", "propose", "a", "method", "by", "which", "to", "monitor", "bladder", "toxicity", "in", "patients", "in", "our", "long", "term", "phase", "4", "clinical", "trials", "(long", "term", "was", "defined", "as", "at", "least", "1", "year)", "2.", "They", "indicated", "an", "inclination", "to", "rescind", "the", "written", "request", "for", "pediatric", "exclusivity", "based", "on", "their", "concern", "about", "bladder", "tumors.", "3.", "They", "requested", "us", "to", "give", "some", "consideration", "to", "a", "label", "change", "that", "would", "reflect", "possible", "relatedness", "of", "tumor", "formation", "to", "mechanism", "(dual", "PPAR", "agonist)", "instead", "of", "the", "current", "language", "(\"The", "relationship", "of", "these", "findings", "in", "male", "rats", "to", "humans", "is", "unclear.\")", "DISCUSSION", "POINTS", "to", "briefly", "review", "the", "toxicity", "study", "results", "of", "pioglitazone,", "particularly", "carcinogenicity", "studies", "b.", "to", "summarise", "discussions", "with", "the", "CPMP", "to", "submit", "literature", "suggesting", "that", "pioglitazone", "suppresses", "the", "cell", "growth,", "particularly", "urinary", "bladder", "cell", "1.", "to", "perform", "an", "in-vitro", "study", "to", "evaluate", "the", "cell", "growth", "and", "cell", "growth", "inhibition", "with", "piogliatzone", "e.", "to", "investigate", "carbonic", "anhydrase", "inhibiting", "activity", "of", "NN622,", "pioglitazone", "and", "rosiglitazone", "f.", "to", "compare", "PPAR", "agonists", "in", "terms", "of", "alpha", "and", "gamma", "activities", "g.", "to", "differentiate", "between", "glitazones", "and", "glitazars", "h.", "to", "consult", "with", "non-clinical", "external", "experts", "for", "their", "expertise", "i.", "to", "find", "a", "rationale", "for", "not", "doing", "clinical", "monitoring", "j-", "a", "monotoring", "method", "k", ".", "a", "case", "control", "study", "1.", "a", "pharmacoepidemiology", "study", "m.", "to", "submit", "a", "report", "from", "a", "Japanese", "follow", "up", "study", "for", "pioglitazone", "n.", "to", "assess", "cases", "from", "database", "search", "for", "pioglitazone", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019749", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupbodocoboosts.ucsf.edu/docs/pljf0226" ]

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{ "match_score": 1, "matched_text": "06 6204 2244", "start": 17, "text": "06 6204 2244" }

{ "de": "was ist das Datum und die Zeit erwähnt?", "en": "what is the date and time mentioned ?", "es": "¿Cuál es la fecha y hora mencionadas?", "fr": "Quelle est la date et l'heure mentionnées?", "it": "Qual è la data e l'ora di cui si parla?" }

[ "10/27/93 09:36:07" ]

[ "From:", "PLK", "RCC1", "Date", "and", "time", "10/27/93", "09", ":", "36:07", "To:", "PJDANIEL-", "-", "PW17", "PO", "PETER", "J.", "DANIELS", "CC:", "RJWELTER-", "-", "PW17", "PO", "RICHARD", "J.", "WELTER", "LTWELCH", "--RCC1", "LAWRENCE", "T", "WELCH", "From:", "plruppel", "subject:", "Pioglitazone", "statement", "Actually,", "this", "statement", "reflects", "pretty", "accurately", "the", "stand", "that", "Jim", "Moe", "and", "Larry", "Olanoff", "presented", "to", "Takeda", "in", "Osaka.", "There", "are", "preclinical", "issues", "and", "the", "amount", "of", "preclinical", "work", "that", "would", "be", "needed", "to", "address", "these", "issues", "and", "the", "modest", "clinical", "efficacy", "that", "has", "been", "seen", "do", "not", "justify", "development", "in", "accordance", "with", "Upjohn's", "business", "needs.", "Larry", "does", "not", "feel", "that", "there", "is", "a", "need", "for", "an", "\"Upjohn", "statement\".", "Please", "let", "me", "know", "if", "you", "want", "to", "discuss", "this", "further.", "Patty", "***", "Forwarding", "note", "from", "PJDANIEL--PW17PO", "10/26/93", "15:44", "*", "*", "*", "From:", "PJDANIEL", "To:", "PLRUPPEL--RCC1", "RUPPEL,", "PATRICIA", "CC", ":", "PJDANIEL", "RJWELTER", "LTWELCH", "-", "-RCC1", "WELCH,", "LAWRENCE", "Subject:", "Pioglitazone", "statement", "Patty,", "thanks", "for", "the", "Takeda", "letter.", "Some", "of", "my", "colleagues", "are", "concerned", "about", "the", "lack", "of", "frankness", "(and", "honesty?)", "of", "the", "Takeda", "statement.", "We", "realise", "we", "are", "hemmed", "in", "by", "a", "confidentiality", "clause,", "but", "does", "this", "have", "the", "endorsement", "of", "our", "senior", "management", ".", "Regards,", "Peter.", "tile", "-", "Takedy", "blogde", "fizone", "license", "ast", "CONFIDENTIAL", "-", "SUBJECT", "TO", "PROTECTIVE", "ORDER", "UPJ-0065604", "Source:", "https://www.indupbydemoodonts.ucsf.edu/docs/sljf0226" ]

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{ "match_score": 0.894736847645429, "matched_text": "10/27/93 09 : 36:07", "start": 29, "text": "10/27/93 09:36:07" }

{ "de": "Was wird in dem Thema erwähnt?", "en": "what is mentioned in the subject ?", "es": "¿Qué se menciona en el tema?", "fr": "qu'est-ce qui est mentionné dans le sujet?", "it": "che cosa viene menzionato nell'argomento?" }

[ "Pioglitazone statement", "pioglitazone statement" ]

[ "From:", "PLK", "RCC1", "Date", "and", "time", "10/27/93", "09", ":", "36:07", "To:", "PJDANIEL-", "-", "PW17", "PO", "PETER", "J.", "DANIELS", "CC:", "RJWELTER-", "-", "PW17", "PO", "RICHARD", "J.", "WELTER", "LTWELCH", "--RCC1", "LAWRENCE", "T", "WELCH", "From:", "plruppel", "subject:", "Pioglitazone", "statement", "Actually,", "this", "statement", "reflects", "pretty", "accurately", "the", "stand", "that", "Jim", "Moe", "and", "Larry", "Olanoff", "presented", "to", "Takeda", "in", "Osaka.", "There", "are", "preclinical", "issues", "and", "the", "amount", "of", "preclinical", "work", "that", "would", "be", "needed", "to", "address", "these", "issues", "and", "the", "modest", "clinical", "efficacy", "that", "has", "been", "seen", "do", "not", "justify", "development", "in", "accordance", "with", "Upjohn's", "business", "needs.", "Larry", "does", "not", "feel", "that", "there", "is", "a", "need", "for", "an", "\"Upjohn", "statement\".", "Please", "let", "me", "know", "if", "you", "want", "to", "discuss", "this", "further.", "Patty", "***", "Forwarding", "note", "from", "PJDANIEL--PW17PO", "10/26/93", "15:44", "*", "*", "*", "From:", "PJDANIEL", "To:", "PLRUPPEL--RCC1", "RUPPEL,", "PATRICIA", "CC", ":", "PJDANIEL", "RJWELTER", "LTWELCH", "-", "-RCC1", "WELCH,", "LAWRENCE", "Subject:", "Pioglitazone", "statement", "Patty,", "thanks", "for", "the", "Takeda", "letter.", "Some", "of", "my", "colleagues", "are", "concerned", "about", "the", "lack", "of", "frankness", "(and", "honesty?)", "of", "the", "Takeda", "statement.", "We", "realise", "we", "are", "hemmed", "in", "by", "a", "confidentiality", "clause,", "but", "does", "this", "have", "the", "endorsement", "of", "our", "senior", "management", ".", "Regards,", "Peter.", "tile", "-", "Takedy", "blogde", "fizone", "license", "ast", "CONFIDENTIAL", "-", "SUBJECT", "TO", "PROTECTIVE", "ORDER", "UPJ-0065604", "Source:", "https://www.indupbydemoodonts.ucsf.edu/docs/sljf0226" ]

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{ "match_score": 1, "matched_text": "Pioglitazone statement", "start": 188, "text": "Pioglitazone statement" }

{ "de": "An wen wurde diese E-Mail geschickt?", "en": "To whom this email was send?", "es": "¿A quién se envió este correo electrónico?", "fr": "À qui ce courriel a-t-il été envoyé?", "it": "A chi è stata inviata questa email?" }

[ "PETER J. DANIELS", "PJ DANIEL--PW17PO PETER J. DANIELS" ]

[ "From:", "PLK", "RCC1", "Date", "and", "time", "10/27/93", "09", ":", "36:07", "To:", "PJDANIEL-", "-", "PW17", "PO", "PETER", "J.", "DANIELS", "CC:", "RJWELTER-", "-", "PW17", "PO", "RICHARD", "J.", "WELTER", "LTWELCH", "--RCC1", "LAWRENCE", "T", "WELCH", "From:", "plruppel", "subject:", "Pioglitazone", "statement", "Actually,", "this", "statement", "reflects", "pretty", "accurately", "the", "stand", "that", "Jim", "Moe", "and", "Larry", "Olanoff", "presented", "to", "Takeda", "in", "Osaka.", "There", "are", "preclinical", "issues", "and", "the", "amount", "of", "preclinical", "work", "that", "would", "be", "needed", "to", "address", "these", "issues", "and", "the", "modest", "clinical", "efficacy", "that", "has", "been", "seen", "do", "not", "justify", "development", "in", "accordance", "with", "Upjohn's", "business", "needs.", "Larry", "does", "not", "feel", "that", "there", "is", "a", "need", "for", "an", "\"Upjohn", "statement\".", "Please", "let", "me", "know", "if", "you", "want", "to", "discuss", "this", "further.", "Patty", "***", "Forwarding", "note", "from", "PJDANIEL--PW17PO", "10/26/93", "15:44", "*", "*", "*", "From:", "PJDANIEL", "To:", "PLRUPPEL--RCC1", "RUPPEL,", "PATRICIA", "CC", ":", "PJDANIEL", "RJWELTER", "LTWELCH", "-", "-RCC1", "WELCH,", "LAWRENCE", "Subject:", "Pioglitazone", "statement", "Patty,", "thanks", "for", "the", "Takeda", "letter.", "Some", "of", "my", "colleagues", "are", "concerned", "about", "the", "lack", "of", "frankness", "(and", "honesty?)", "of", "the", "Takeda", "statement.", "We", "realise", "we", "are", "hemmed", "in", "by", "a", "confidentiality", "clause,", "but", "does", "this", "have", "the", "endorsement", "of", "our", "senior", "management", ".", "Regards,", "Peter.", "tile", "-", "Takedy", "blogde", "fizone", "license", "ast", "CONFIDENTIAL", "-", "SUBJECT", "TO", "PROTECTIVE", "ORDER", "UPJ-0065604", "Source:", "https://www.indupbydemoodonts.ucsf.edu/docs/sljf0226" ]

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{ "match_score": 1, "matched_text": "PETER J. DANIELS", "start": 73, "text": "PETER J. DANIELS" }

{ "de": "Was ist das Datum, das in der Weiterleitungsnotiz erwähnt wird?", "en": "what is the date mentioned in the forwarding note ?", "es": "¿Cuál es la fecha mencionada en la nota de reenvío?", "fr": "Quelle est la date mentionnée dans la note d'envoi?", "it": "Qual è la data indicata nella nota di trasmissione?" }

[ "10/26/93", "10/26/93 15:44" ]

[ "From:", "PLK", "RCC1", "Date", "and", "time", "10/27/93", "09", ":", "36:07", "To:", "PJDANIEL-", "-", "PW17", "PO", "PETER", "J.", "DANIELS", "CC:", "RJWELTER-", "-", "PW17", "PO", "RICHARD", "J.", "WELTER", "LTWELCH", "--RCC1", "LAWRENCE", "T", "WELCH", "From:", "plruppel", "subject:", "Pioglitazone", "statement", "Actually,", "this", "statement", "reflects", "pretty", "accurately", "the", "stand", "that", "Jim", "Moe", "and", "Larry", "Olanoff", "presented", "to", "Takeda", "in", "Osaka.", "There", "are", "preclinical", "issues", "and", "the", "amount", "of", "preclinical", "work", "that", "would", "be", "needed", "to", "address", "these", "issues", "and", "the", "modest", "clinical", "efficacy", "that", "has", "been", "seen", "do", "not", "justify", "development", "in", "accordance", "with", "Upjohn's", "business", "needs.", "Larry", "does", "not", "feel", "that", "there", "is", "a", "need", "for", "an", "\"Upjohn", "statement\".", "Please", "let", "me", "know", "if", "you", "want", "to", "discuss", "this", "further.", "Patty", "***", "Forwarding", "note", "from", "PJDANIEL--PW17PO", "10/26/93", "15:44", "*", "*", "*", "From:", "PJDANIEL", "To:", "PLRUPPEL--RCC1", "RUPPEL,", "PATRICIA", "CC", ":", "PJDANIEL", "RJWELTER", "LTWELCH", "-", "-RCC1", "WELCH,", "LAWRENCE", "Subject:", "Pioglitazone", "statement", "Patty,", "thanks", "for", "the", "Takeda", "letter.", "Some", "of", "my", "colleagues", "are", "concerned", "about", "the", "lack", "of", "frankness", "(and", "honesty?)", "of", "the", "Takeda", "statement.", "We", "realise", "we", "are", "hemmed", "in", "by", "a", "confidentiality", "clause,", "but", "does", "this", "have", "the", "endorsement", "of", "our", "senior", "management", ".", "Regards,", "Peter.", "tile", "-", "Takedy", "blogde", "fizone", "license", "ast", "CONFIDENTIAL", "-", "SUBJECT", "TO", "PROTECTIVE", "ORDER", "UPJ-0065604", "Source:", "https://www.indupbydemoodonts.ucsf.edu/docs/sljf0226" ]

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{ "match_score": 1, "matched_text": "10/26/93", "start": 738, "text": "10/26/93" }

{ "de": "Was ist die Zeit, die in der Weiterleitungsnotiz erwähnt wird?", "en": "what is the time mentioned in the forwarding note ?", "es": "¿Cuál es el tiempo mencionado en la nota de reenvío?", "fr": "Quelle est la période mentionnée dans la note de renvoi?", "it": "Qual è l'ora indicata nella nota di trasmissione?" }

[ "15:44" ]

[ "From:", "PLK", "RCC1", "Date", "and", "time", "10/27/93", "09", ":", "36:07", "To:", "PJDANIEL-", "-", "PW17", "PO", "PETER", "J.", "DANIELS", "CC:", "RJWELTER-", "-", "PW17", "PO", "RICHARD", "J.", "WELTER", "LTWELCH", "--RCC1", "LAWRENCE", "T", "WELCH", "From:", "plruppel", "subject:", "Pioglitazone", "statement", "Actually,", "this", "statement", "reflects", "pretty", "accurately", "the", "stand", "that", "Jim", "Moe", "and", "Larry", "Olanoff", "presented", "to", "Takeda", "in", "Osaka.", "There", "are", "preclinical", "issues", "and", "the", "amount", "of", "preclinical", "work", "that", "would", "be", "needed", "to", "address", "these", "issues", "and", "the", "modest", "clinical", "efficacy", "that", "has", "been", "seen", "do", "not", "justify", "development", "in", "accordance", "with", "Upjohn's", "business", "needs.", "Larry", "does", "not", "feel", "that", "there", "is", "a", "need", "for", "an", "\"Upjohn", "statement\".", "Please", "let", "me", "know", "if", "you", "want", "to", "discuss", "this", "further.", "Patty", "***", "Forwarding", "note", "from", "PJDANIEL--PW17PO", "10/26/93", "15:44", "*", "*", "*", "From:", "PJDANIEL", "To:", "PLRUPPEL--RCC1", "RUPPEL,", "PATRICIA", "CC", ":", "PJDANIEL", "RJWELTER", "LTWELCH", "-", "-RCC1", "WELCH,", "LAWRENCE", "Subject:", "Pioglitazone", "statement", "Patty,", "thanks", "for", "the", "Takeda", "letter.", "Some", "of", "my", "colleagues", "are", "concerned", "about", "the", "lack", "of", "frankness", "(and", "honesty?)", "of", "the", "Takeda", "statement.", "We", "realise", "we", "are", "hemmed", "in", "by", "a", "confidentiality", "clause,", "but", "does", "this", "have", "the", "endorsement", "of", "our", "senior", "management", ".", "Regards,", "Peter.", "tile", "-", "Takedy", "blogde", "fizone", "license", "ast", "CONFIDENTIAL", "-", "SUBJECT", "TO", "PROTECTIVE", "ORDER", "UPJ-0065604", "Source:", "https://www.indupbydemoodonts.ucsf.edu/docs/sljf0226" ]

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{ "match_score": 1, "matched_text": "15:44", "start": 747, "text": "15:44" }

{ "de": "Wem wurde diese E-Mail verwehrt?", "en": "To whom this email was forwaded?", "es": "¿A quién se perdonó este correo electrónico?", "fr": "À qui cet e-mail a-t-il été annulé?", "it": "A chi è stata forwaded questa email?" }

[ "RUPPEL, PATRICIA", "PLRUPPEL--RCC1 RUPPEL, PATRICIA" ]

[ "From:", "PLK", "RCC1", "Date", "and", "time", "10/27/93", "09", ":", "36:07", "To:", "PJDANIEL-", "-", "PW17", "PO", "PETER", "J.", "DANIELS", "CC:", "RJWELTER-", "-", "PW17", "PO", "RICHARD", "J.", "WELTER", "LTWELCH", "--RCC1", "LAWRENCE", "T", "WELCH", "From:", "plruppel", "subject:", "Pioglitazone", "statement", "Actually,", "this", "statement", "reflects", "pretty", "accurately", "the", "stand", "that", "Jim", "Moe", "and", "Larry", "Olanoff", "presented", "to", "Takeda", "in", "Osaka.", "There", "are", "preclinical", "issues", "and", "the", "amount", "of", "preclinical", "work", "that", "would", "be", "needed", "to", "address", "these", "issues", "and", "the", "modest", "clinical", "efficacy", "that", "has", "been", "seen", "do", "not", "justify", "development", "in", "accordance", "with", "Upjohn's", "business", "needs.", "Larry", "does", "not", "feel", "that", "there", "is", "a", "need", "for", "an", "\"Upjohn", "statement\".", "Please", "let", "me", "know", "if", "you", "want", "to", "discuss", "this", "further.", "Patty", "***", "Forwarding", "note", "from", "PJDANIEL--PW17PO", "10/26/93", "15:44", "*", "*", "*", "From:", "PJDANIEL", "To:", "PLRUPPEL--RCC1", "RUPPEL,", "PATRICIA", "CC", ":", "PJDANIEL", "RJWELTER", "LTWELCH", "-", "-RCC1", "WELCH,", "LAWRENCE", "Subject:", "Pioglitazone", "statement", "Patty,", "thanks", "for", "the", "Takeda", "letter.", "Some", "of", "my", "colleagues", "are", "concerned", "about", "the", "lack", "of", "frankness", "(and", "honesty?)", "of", "the", "Takeda", "statement.", "We", "realise", "we", "are", "hemmed", "in", "by", "a", "confidentiality", "clause,", "but", "does", "this", "have", "the", "endorsement", "of", "our", "senior", "management", ".", "Regards,", "Peter.", "tile", "-", "Takedy", "blogde", "fizone", "license", "ast", "CONFIDENTIAL", "-", "SUBJECT", "TO", "PROTECTIVE", "ORDER", "UPJ-0065604", "Source:", "https://www.indupbydemoodonts.ucsf.edu/docs/sljf0226" ]

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{ "match_score": 1, "matched_text": "RUPPEL, PATRICIA", "start": 793, "text": "RUPPEL, PATRICIA" }

{ "de": "wie ist der Name des Unternehmens", "en": "what is the name of the company", "es": "cuál es el nombre de la empresa", "fr": "quel est le nom de l'entreprise", "it": "qual è il nome dell'azienda" }

[ "THE UPJOHN COMPANY" ]

[ "TAKEDA", "Aat", "THE", "UPJOHN", "COMPANY", "KALAMAZOO,", "MICHIGAN", "49001-0199.", "U.S.A.", "TELEPHONE:", "(616)", "323-4000.", "J.", "R.", "MITCHELL,", "M.D.", "A.D.", "Vice", "Chairman", "of", "the", "Board", "TELEPHONE.", "(614)", "385-7053", "(816)", "385-5291", "September", "21,", "1993", "Tai", "Matsuzawa,", "Ph.D.", "Managing", "Director", "Vice", "President,", "Pharmaceutical", "Group", "Takeda", "Chemical", "Industries,", "Lid,", "1-1,", "Doshomachi", "4-Chome", "Chuo-Ku,", "Osaka", "541", "Japan", "Dear", "Doctor", "Matsuzawa:", "As", "you", "know,", "Upjohn", "has", "committed", "to", "notify", "Takeda", "by", "October", "1,", "1993,", "of", "our", "intentions", "regarding", "further", "clinical", "development", "of", "pioglitazone.", "On", "September", "20", "our", "Pharmaceutical", "Executive", "Council,", "Upjohn's", "highest", "scientific", "decision-making", "body,", "carefully", "reviewed", "the", "results", "of", "the", "toxicology", "and", "clinical", "studies.", "The", "decision", "of", "the", "Council", "was", "that", "Upjohn", "will", "not", "go", "forward", "with", "pioglitazone", "in", "the", "clinic.", "The", "Council", "decided", "that", "further", "clinical", "development", "of", "pioglitazone", "could", "not", "be", "justified", "based", "on", "their", "concern", "regarding", "pioglitazone's", "margin", "of", "safety.", "As", "a", "consequence", "of", "this", "decision,", "Upjohn", "also", "must", "decline", "participation", "with", "Takeda", "on", "the", "proposed", "pioglitazone", "study", "in", "Canada.", "It", "is", "with", "deep", "regret", "that", "I", "convey", "this", "message.", "As", "you", "know", "Upjohn", "and", "Takeda", "enjoy", "a", "strong", "and", "beneficial", "relationship", "based", "on", "mutual", "respect.", "It", "is", "a", "great", "disappointment", "to", "us", "that", "we", "will", "not", "have", "the", "opportunity", "of", "further", "interactions", "and", "collaboration", "with", "Takeda", "on", "this", "project.", "Hopefully,", "we", "will", "find", "other", "opportunities", "for", "collaboration", "in", "the", "future.", "I", "have", "instructed", "my", "staff", "to", "work", "closely", "with", "Takeda", "personnel", "in", "regards", "to", "the", "release", "of", "any", "information,", "data,", "FDA", "notifications,", "and", "other", "issues", "to", "ensure", "Takeda's", "interests", "and", "wishes", "are", "followed.", "With", "best", "personal", "regards,", "Sincerely,", "President,", "Upjohn", "Laboratories", "Worldwide", "Research,", "Development,", "&", "Medical", "Affairs", "CONFIDENTIAL", "-", "SUBJECT", "TO", "PROTECTIVE", "ORDER", "UPJ-0065603", "Source:", "https://www.indup606-oooo2ts.ucsf.edu/docs/zsjf0226" ]

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{ "match_score": 1, "matched_text": "THE UPJOHN COMPANY", "start": 11, "text": "THE UPJOHN COMPANY" }

{ "de": "Was ist das erwähnte Datum und Jahr?", "en": "what is the date and year mentioned ?", "es": "¿Cuál es la fecha y el año mencionados?", "fr": "Quelle est la date et l'année mentionnées?", "it": "Qual è la data e l'anno menzionati?" }

[ "September 21, 1993", "september 21 , 1993" ]

[ "TAKEDA", "Aat", "THE", "UPJOHN", "COMPANY", "KALAMAZOO,", "MICHIGAN", "49001-0199.", "U.S.A.", "TELEPHONE:", "(616)", "323-4000.", "J.", "R.", "MITCHELL,", "M.D.", "A.D.", "Vice", "Chairman", "of", "the", "Board", "TELEPHONE.", "(614)", "385-7053", "(816)", "385-5291", "September", "21,", "1993", "Tai", "Matsuzawa,", "Ph.D.", "Managing", "Director", "Vice", "President,", "Pharmaceutical", "Group", "Takeda", "Chemical", "Industries,", "Lid,", "1-1,", "Doshomachi", "4-Chome", "Chuo-Ku,", "Osaka", "541", "Japan", "Dear", "Doctor", "Matsuzawa:", "As", "you", "know,", "Upjohn", "has", "committed", "to", "notify", "Takeda", "by", "October", "1,", "1993,", "of", "our", "intentions", "regarding", "further", "clinical", "development", "of", "pioglitazone.", "On", "September", "20", "our", "Pharmaceutical", "Executive", "Council,", "Upjohn's", "highest", "scientific", "decision-making", "body,", "carefully", "reviewed", "the", "results", "of", "the", "toxicology", "and", "clinical", "studies.", "The", "decision", "of", "the", "Council", "was", "that", "Upjohn", "will", "not", "go", "forward", "with", "pioglitazone", "in", "the", "clinic.", "The", "Council", "decided", "that", "further", "clinical", "development", "of", "pioglitazone", "could", "not", "be", "justified", "based", "on", "their", "concern", "regarding", "pioglitazone's", "margin", "of", "safety.", "As", "a", "consequence", "of", "this", "decision,", "Upjohn", "also", "must", "decline", "participation", "with", "Takeda", "on", "the", "proposed", "pioglitazone", "study", "in", "Canada.", "It", "is", "with", "deep", "regret", "that", "I", "convey", "this", "message.", "As", "you", "know", "Upjohn", "and", "Takeda", "enjoy", "a", "strong", "and", "beneficial", "relationship", "based", "on", "mutual", "respect.", "It", "is", "a", "great", "disappointment", "to", "us", "that", "we", "will", "not", "have", "the", "opportunity", "of", "further", "interactions", "and", "collaboration", "with", "Takeda", "on", "this", "project.", "Hopefully,", "we", "will", "find", "other", "opportunities", "for", "collaboration", "in", "the", "future.", "I", "have", "instructed", "my", "staff", "to", "work", "closely", "with", "Takeda", "personnel", "in", "regards", "to", "the", "release", "of", "any", "information,", "data,", "FDA", "notifications,", "and", "other", "issues", "to", "ensure", "Takeda's", "interests", "and", "wishes", "are", "followed.", "With", "best", "personal", "regards,", "Sincerely,", "President,", "Upjohn", "Laboratories", "Worldwide", "Research,", "Development,", "&", "Medical", "Affairs", "CONFIDENTIAL", "-", "SUBJECT", "TO", "PROTECTIVE", "ORDER", "UPJ-0065603", "Source:", "https://www.indup606-oooo2ts.ucsf.edu/docs/zsjf0226" ]

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{ "match_score": 1, "matched_text": "September 21, 1993", "start": 190, "text": "September 21, 1993" }

{ "de": "Welche Firma wird im Briefkopf erwähnt?", "en": "Which company is mentioned in the letterhead?", "es": "¿Qué compañía se menciona en el membrete?", "fr": "Quelle société est mentionnée dans l'en-tête?", "it": "Quale azienda è menzionata nella carta intestata?" }

[ "THE UPJOHN COMPANY" ]

[ "TAKEDA", "Aat", "THE", "UPJOHN", "COMPANY", "KALAMAZOO,", "MICHIGAN", "49001-0199.", "U.S.A.", "TELEPHONE:", "(616)", "323-4000.", "J.", "R.", "MITCHELL,", "M.D.", "A.D.", "Vice", "Chairman", "of", "the", "Board", "TELEPHONE.", "(614)", "385-7053", "(816)", "385-5291", "September", "21,", "1993", "Tai", "Matsuzawa,", "Ph.D.", "Managing", "Director", "Vice", "President,", "Pharmaceutical", "Group", "Takeda", "Chemical", "Industries,", "Lid,", "1-1,", "Doshomachi", "4-Chome", "Chuo-Ku,", "Osaka", "541", "Japan", "Dear", "Doctor", "Matsuzawa:", "As", "you", "know,", "Upjohn", "has", "committed", "to", "notify", "Takeda", "by", "October", "1,", "1993,", "of", "our", "intentions", "regarding", "further", "clinical", "development", "of", "pioglitazone.", "On", "September", "20", "our", "Pharmaceutical", "Executive", "Council,", "Upjohn's", "highest", "scientific", "decision-making", "body,", "carefully", "reviewed", "the", "results", "of", "the", "toxicology", "and", "clinical", "studies.", "The", "decision", "of", "the", "Council", "was", "that", "Upjohn", "will", "not", "go", "forward", "with", "pioglitazone", "in", "the", "clinic.", "The", "Council", "decided", "that", "further", "clinical", "development", "of", "pioglitazone", "could", "not", "be", "justified", "based", "on", "their", "concern", "regarding", "pioglitazone's", "margin", "of", "safety.", "As", "a", "consequence", "of", "this", "decision,", "Upjohn", "also", "must", "decline", "participation", "with", "Takeda", "on", "the", "proposed", "pioglitazone", "study", "in", "Canada.", "It", "is", "with", "deep", "regret", "that", "I", "convey", "this", "message.", "As", "you", "know", "Upjohn", "and", "Takeda", "enjoy", "a", "strong", "and", "beneficial", "relationship", "based", "on", "mutual", "respect.", "It", "is", "a", "great", "disappointment", "to", "us", "that", "we", "will", "not", "have", "the", "opportunity", "of", "further", "interactions", "and", "collaboration", "with", "Takeda", "on", "this", "project.", "Hopefully,", "we", "will", "find", "other", "opportunities", "for", "collaboration", "in", "the", "future.", "I", "have", "instructed", "my", "staff", "to", "work", "closely", "with", "Takeda", "personnel", "in", "regards", "to", "the", "release", "of", "any", "information,", "data,", "FDA", "notifications,", "and", "other", "issues", "to", "ensure", "Takeda's", "interests", "and", "wishes", "are", "followed.", "With", "best", "personal", "regards,", "Sincerely,", "President,", "Upjohn", "Laboratories", "Worldwide", "Research,", "Development,", "&", "Medical", "Affairs", "CONFIDENTIAL", "-", "SUBJECT", "TO", "PROTECTIVE", "ORDER", "UPJ-0065603", "Source:", "https://www.indup606-oooo2ts.ucsf.edu/docs/zsjf0226" ]

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{ "match_score": 1, "matched_text": "THE UPJOHN COMPANY", "start": 11, "text": "THE UPJOHN COMPANY" }

{ "de": "In welchem Land befindet sich die Firma upjohn?", "en": "in which country the upjohn company is located ?", "es": "¿En qué país se encuentra la empresa upjohn?", "fr": "Dans quel pays se trouve la société upjohn?", "it": "in quale paese si trova la società upjohn?" }

[ "U.S.A", "USA" ]

[ "TAKEDA", "Aat", "THE", "UPJOHN", "COMPANY", "KALAMAZOO,", "MICHIGAN", "49001-0199.", "U.S.A.", "TELEPHONE:", "(616)", "323-4000.", "J.", "R.", "MITCHELL,", "M.D.", "A.D.", "Vice", "Chairman", "of", "the", "Board", "TELEPHONE.", "(614)", "385-7053", "(816)", "385-5291", "September", "21,", "1993", "Tai", "Matsuzawa,", "Ph.D.", "Managing", "Director", "Vice", "President,", "Pharmaceutical", "Group", "Takeda", "Chemical", "Industries,", "Lid,", "1-1,", "Doshomachi", "4-Chome", "Chuo-Ku,", "Osaka", "541", "Japan", "Dear", "Doctor", "Matsuzawa:", "As", "you", "know,", "Upjohn", "has", "committed", "to", "notify", "Takeda", "by", "October", "1,", "1993,", "of", "our", "intentions", "regarding", "further", "clinical", "development", "of", "pioglitazone.", "On", "September", "20", "our", "Pharmaceutical", "Executive", "Council,", "Upjohn's", "highest", "scientific", "decision-making", "body,", "carefully", "reviewed", "the", "results", "of", "the", "toxicology", "and", "clinical", "studies.", "The", "decision", "of", "the", "Council", "was", "that", "Upjohn", "will", "not", "go", "forward", "with", "pioglitazone", "in", "the", "clinic.", "The", "Council", "decided", "that", "further", "clinical", "development", "of", "pioglitazone", "could", "not", "be", "justified", "based", "on", "their", "concern", "regarding", "pioglitazone's", "margin", "of", "safety.", "As", "a", "consequence", "of", "this", "decision,", "Upjohn", "also", "must", "decline", "participation", "with", "Takeda", "on", "the", "proposed", "pioglitazone", "study", "in", "Canada.", "It", "is", "with", "deep", "regret", "that", "I", "convey", "this", "message.", "As", "you", "know", "Upjohn", "and", "Takeda", "enjoy", "a", "strong", "and", "beneficial", "relationship", "based", "on", "mutual", "respect.", "It", "is", "a", "great", "disappointment", "to", "us", "that", "we", "will", "not", "have", "the", "opportunity", "of", "further", "interactions", "and", "collaboration", "with", "Takeda", "on", "this", "project.", "Hopefully,", "we", "will", "find", "other", "opportunities", "for", "collaboration", "in", "the", "future.", "I", "have", "instructed", "my", "staff", "to", "work", "closely", "with", "Takeda", "personnel", "in", "regards", "to", "the", "release", "of", "any", "information,", "data,", "FDA", "notifications,", "and", "other", "issues", "to", "ensure", "Takeda's", "interests", "and", "wishes", "are", "followed.", "With", "best", "personal", "regards,", "Sincerely,", "President,", "Upjohn", "Laboratories", "Worldwide", "Research,", "Development,", "&", "Medical", "Affairs", "CONFIDENTIAL", "-", "SUBJECT", "TO", "PROTECTIVE", "ORDER", "UPJ-0065603", "Source:", "https://www.indup606-oooo2ts.ucsf.edu/docs/zsjf0226" ]

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{ "match_score": 1, "matched_text": "U.S.A", "start": 62, "text": "U.S.A" }

{ "de": "Was ist das Fax erwähnt?", "en": "what is the fax mentioned ?", "es": "¿Cuál es el fax mencionado?", "fr": "Qu'est-ce que le fax mentionné?", "it": "Qual è il fax menzionato?" }

[ "06 6204 2244" ]

[ "08/07/2002", "18:46", "06", "6204", "2244", "2002", "08/08", "21:49", "FAX", "06", "6204", "2244", "TAKEDA", "DEVELOP", "DIVISION", "41", "003/006", "contact,", "what", "can", "we", "do?", "(7)", "As", "we", "point", "out", "in", "our", "action", "plan", "(see", "Action", "1,", "(1),", "iv),", "we", "can", "claim", "that", "the", "two-stage", "carcinogenicity", "model", "is", "considered", "to", "be", "too", "sensitive", "and", "likely", "to", "result", "in", "false", "positive.", "(8)", "We", "can", "ask", "FDA", "directly", "to", "disclose", "the", "details", "of", "\"promotion", "study\"", "and", "2-year", "carcinogenicity", "studies", "in", "our", "first", "response", "to", "FDA.", "It", "is", "not", "too", "late", "to", "think", "about", "a", "contact", "with", "NN", "after", "FDA's", "response", "to", "our", "first", "comments.", "[Conclusion]", "(1)", "Benefit<", "<Risk", "(2)", "This", "would", "not", "be", "the", "best", "moment", "to", "have", "a", "contact", "with", "NN.", "(3)", "We", "would", "better", "respond", "to", "FDA", "based", "on", "published", "papers,", "our", "data,", "NN's", "official", "comments", "on", "their", "homepage", "and", "the", "information", "that", "FDA", "gave", "TPNA", "about", "NN-622", "and", "pioglitazone", "and", "not", "on", "the", "information", "obtained", "from", "a", "contact", "with", "NN", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019746", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupbodocoooosts.ucsf.edu/docs/pljf0226" ]

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{ "match_score": 1, "matched_text": "06 6204 2244", "start": 17, "text": "06 6204 2244" }

{ "de": "was ist Jahr Datum und Zeit erwähnt?", "en": "what is year date and time mentioned?", "es": "¿Qué se menciona fecha y hora del año?", "fr": "Quelle est la date et l'heure de l'année mentionnées?", "it": "che cos'è la data e l'ora dell'anno?" }

[ "2002 08/08 21:49" ]

[ "08/07/2002", "18:46", "06", "6204", "2244", "2002", "08/08", "21:49", "FAX", "06", "6204", "2244", "TAKEDA", "DEVELOP", "DIVISION", "41", "003/006", "contact,", "what", "can", "we", "do?", "(7)", "As", "we", "point", "out", "in", "our", "action", "plan", "(see", "Action", "1,", "(1),", "iv),", "we", "can", "claim", "that", "the", "two-stage", "carcinogenicity", "model", "is", "considered", "to", "be", "too", "sensitive", "and", "likely", "to", "result", "in", "false", "positive.", "(8)", "We", "can", "ask", "FDA", "directly", "to", "disclose", "the", "details", "of", "\"promotion", "study\"", "and", "2-year", "carcinogenicity", "studies", "in", "our", "first", "response", "to", "FDA.", "It", "is", "not", "too", "late", "to", "think", "about", "a", "contact", "with", "NN", "after", "FDA's", "response", "to", "our", "first", "comments.", "[Conclusion]", "(1)", "Benefit<", "<Risk", "(2)", "This", "would", "not", "be", "the", "best", "moment", "to", "have", "a", "contact", "with", "NN.", "(3)", "We", "would", "better", "respond", "to", "FDA", "based", "on", "published", "papers,", "our", "data,", "NN's", "official", "comments", "on", "their", "homepage", "and", "the", "information", "that", "FDA", "gave", "TPNA", "about", "NN-622", "and", "pioglitazone", "and", "not", "on", "the", "information", "obtained", "from", "a", "contact", "with", "NN", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019746", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupbodocoooosts.ucsf.edu/docs/pljf0226" ]

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{ "match_score": 1, "matched_text": "2002 08/08 21:49", "start": 30, "text": "2002 08/08 21:49" }

{ "de": "Wie lautet der Name der Abteilung?", "en": "what is the name of the division ?", "es": "¿Cuál es el nombre de la división?", "fr": "Quel est le nom de la division?", "it": "Qual è il nome della divisione?" }

[ "TAKEDA DEVELOP DIVISION", "Takeda Develop division" ]

[ "08/07/2002", "18:46", "06", "6204", "2244", "2002", "08/08", "21:49", "FAX", "06", "6204", "2244", "TAKEDA", "DEVELOP", "DIVISION", "41", "003/006", "contact,", "what", "can", "we", "do?", "(7)", "As", "we", "point", "out", "in", "our", "action", "plan", "(see", "Action", "1,", "(1),", "iv),", "we", "can", "claim", "that", "the", "two-stage", "carcinogenicity", "model", "is", "considered", "to", "be", "too", "sensitive", "and", "likely", "to", "result", "in", "false", "positive.", "(8)", "We", "can", "ask", "FDA", "directly", "to", "disclose", "the", "details", "of", "\"promotion", "study\"", "and", "2-year", "carcinogenicity", "studies", "in", "our", "first", "response", "to", "FDA.", "It", "is", "not", "too", "late", "to", "think", "about", "a", "contact", "with", "NN", "after", "FDA's", "response", "to", "our", "first", "comments.", "[Conclusion]", "(1)", "Benefit<", "<Risk", "(2)", "This", "would", "not", "be", "the", "best", "moment", "to", "have", "a", "contact", "with", "NN.", "(3)", "We", "would", "better", "respond", "to", "FDA", "based", "on", "published", "papers,", "our", "data,", "NN's", "official", "comments", "on", "their", "homepage", "and", "the", "information", "that", "FDA", "gave", "TPNA", "about", "NN-622", "and", "pioglitazone", "and", "not", "on", "the", "information", "obtained", "from", "a", "contact", "with", "NN", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019746", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupbodocoooosts.ucsf.edu/docs/pljf0226" ]

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{ "match_score": 1, "matched_text": "TAKEDA DEVELOP DIVISION", "start": 64, "text": "TAKEDA DEVELOP DIVISION" }

{ "de": "An wen können sie sich direkt wenden, um die Einzelheiten der \"Promotionsstudie\" bekannt zu geben?", "en": "to whom they can ask directly to disclose the details of \"promotion study\"?", "es": "¿a quién pueden pedir directamente que revele los detalles del \"estudio de promoción\"?", "fr": "à qui ils peuvent demander directement de divulguer les détails de \"l'étude de promotion\"?", "it": "a chi possono chiedere direttamente di divulgare i dettagli dello \"studio di promozione\"?" }

[ "FDA" ]

[ "08/07/2002", "18:46", "06", "6204", "2244", "2002", "08/08", "21:49", "FAX", "06", "6204", "2244", "TAKEDA", "DEVELOP", "DIVISION", "41", "003/006", "contact,", "what", "can", "we", "do?", "(7)", "As", "we", "point", "out", "in", "our", "action", "plan", "(see", "Action", "1,", "(1),", "iv),", "we", "can", "claim", "that", "the", "two-stage", "carcinogenicity", "model", "is", "considered", "to", "be", "too", "sensitive", "and", "likely", "to", "result", "in", "false", "positive.", "(8)", "We", "can", "ask", "FDA", "directly", "to", "disclose", "the", "details", "of", "\"promotion", "study\"", "and", "2-year", "carcinogenicity", "studies", "in", "our", "first", "response", "to", "FDA.", "It", "is", "not", "too", "late", "to", "think", "about", "a", "contact", "with", "NN", "after", "FDA's", "response", "to", "our", "first", "comments.", "[Conclusion]", "(1)", "Benefit<", "<Risk", "(2)", "This", "would", "not", "be", "the", "best", "moment", "to", "have", "a", "contact", "with", "NN.", "(3)", "We", "would", "better", "respond", "to", "FDA", "based", "on", "published", "papers,", "our", "data,", "NN's", "official", "comments", "on", "their", "homepage", "and", "the", "information", "that", "FDA", "gave", "TPNA", "about", "NN-622", "and", "pioglitazone", "and", "not", "on", "the", "information", "obtained", "from", "a", "contact", "with", "NN", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019746", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupbodocoooosts.ucsf.edu/docs/pljf0226" ]

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{ "match_score": 1, "matched_text": "FDA", "start": 331, "text": "FDA" }

{ "de": "Wie lautet das im Schreiben genannte Datum?", "en": "what is the date mentioned in the letter", "es": "¿Cuál es la fecha mencionada en la carta", "fr": "quelle est la date mentionnée dans la lettre", "it": "qual è la data indicata nella lettera" }

[ "8 January 2003", "8 january 2003" ]

[ "8", "January", "2003", "To:", "MPDRAP", "I", "Leader", "cc:", "CEOs", "and", "General", "Managers", "of", "Pharmaceutical", "Units", "My", "Concerns", "about", "sNDA", "for", "Actos", "45mg", "in", "the", "USA", "(Reconfirmation)", "Pharmaceutical", "International", "Division", "Y.", "Narai", "I", "express", "my", "opinion", "about", "the", "conclusion", "drawn", "at", "MPDRAP", "Committee", "Meeting", "where", "it", "was", "agreed", "that", "sNDA", "to", "obtain", "the", "approval", "of", "the", "45mg", "combination", "indications", "would", "be", "submitted,", "as", "well", "as", "the", "safety", "update", "based", "on", "the", "commitment", "studies.", "As", "you", "know,", "Actos", "is", "the", "essential", "product", "for", "IPNA", "and", "is", "vital", "to", "the", "survival", "of", "TPNA.", "If", "unfavorable", "revisions", "in", "the", "Actos", "labeling", "are", "made,", "it", "invites", "the", "serious", "risk", "to", "Actos", "in", "the", "US.", "TPNA", "is", "now", "under", "attack", "from", "GSK,", "especially", "by", "Avandamet", "and", "is", "eager", "to", "maintain", "their", "market", "share.", "In", "addition", "to", "this", "attack,", "if", "the", "indications", "of", "Actos", "are", "reduced,", "TPNA", "is", "pushed", "into", "critical", "situation.", "This", "issue", "seriously", "damages", "not", "only", "US", "market", "but", "also", "Takeda's", "global", "strategy.", "Therefore,", "HQ", "should", "be", "extremely", "cautious", "about", "the", "issues", "related", "to", "Actos.", "If", "this", "sNDA", "raises", "the", "argument", "for", "the", "indications", "of", "Actos,", "for", "example,", "reductions", "in", "the", "indications,", "the", "issues", "will", "come", "to", "a", "critical", "path", "like", "as", "I", "mentioned.", "So", "we", "should", "go", "into", "action", "on", "condition", "that", "there", "is", "no", "such", "risk.", "Combination", "therapy", "in", "the", "US", "market", "accounts", "for", "64%", "of", "total", "Actos", "sales.", "(29%", "in", "combination", "with", "SU,", "27%", "Metformin", "and", "8%", "Insulin)", "Regarding", "the", "possibility", "of", "the", "risk", "of", "labeling", "revision,", "International", "Division", "entrusts", "Development", "Division", "with", "final", "decision.", "However,", "just", "to", "be", "sure,", "I", "would", "like", "to", "reconfirm", "that", "this", "sNDA", "dose", "not", "lead", "to", "a", "serious", "situation.", "I", "heard", "that", "TPNA", "R&D", "suggested", "to", "HQ", "and", "is", "getting", "ready", "for", "sNDA", "for", "the", "45mg", "combination", "indications.", "However,", "HQ", "should", "carefully", "judge", "whether", "this", "sNDA", "should", "be", "submitted", "to", "the", "FDA", "or", "not.", "I", "think", "that", "sNDA", "for", "efficacy", "should", "be", "submitted", "only", "when", "there", "is", "no", "risk", "that", "this", "sND", "A", "damages", "the", "current", "labeling.", "According", "to", "the", "results", "of", "PNFP-343,", "combination", "with", "insulin,", "edema", "was", "observed", "more", "often", "than", "Avandia,", "which", "dose", "not", "have", "the", "indication", "for", "combination", "with", "insulin", "and", "CHF", "in", "this", "study", "seems", "to", "be", "dose", "related.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00005583", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupt2290-coots.ucsf.edu/docs/syjf0226" ]

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{ "match_score": 1, "matched_text": "8 January 2003", "start": 0, "text": "8 January 2003" }

{ "de": "An wen ist dieser Brief gerichtet?", "en": "To whom this letter is addressed?", "es": "¿A quién se dirige esta carta?", "fr": "À qui s'adresse cette lettre?", "it": "A chi è indirizzata questa lettera?" }

[ "MPDRAP I Leader" ]

[ "8", "January", "2003", "To:", "MPDRAP", "I", "Leader", "cc:", "CEOs", "and", "General", "Managers", "of", "Pharmaceutical", "Units", "My", "Concerns", "about", "sNDA", "for", "Actos", "45mg", "in", "the", "USA", "(Reconfirmation)", "Pharmaceutical", "International", "Division", "Y.", "Narai", "I", "express", "my", "opinion", "about", "the", "conclusion", "drawn", "at", "MPDRAP", "Committee", "Meeting", "where", "it", "was", "agreed", "that", "sNDA", "to", "obtain", "the", "approval", "of", "the", "45mg", "combination", "indications", "would", "be", "submitted,", "as", "well", "as", "the", "safety", "update", "based", "on", "the", "commitment", "studies.", "As", "you", "know,", "Actos", "is", "the", "essential", "product", "for", "IPNA", "and", "is", "vital", "to", "the", "survival", "of", "TPNA.", "If", "unfavorable", "revisions", "in", "the", "Actos", "labeling", "are", "made,", "it", "invites", "the", "serious", "risk", "to", "Actos", "in", "the", "US.", "TPNA", "is", "now", "under", "attack", "from", "GSK,", "especially", "by", "Avandamet", "and", "is", "eager", "to", "maintain", "their", "market", "share.", "In", "addition", "to", "this", "attack,", "if", "the", "indications", "of", "Actos", "are", "reduced,", "TPNA", "is", "pushed", "into", "critical", "situation.", "This", "issue", "seriously", "damages", "not", "only", "US", "market", "but", "also", "Takeda's", "global", "strategy.", "Therefore,", "HQ", "should", "be", "extremely", "cautious", "about", "the", "issues", "related", "to", "Actos.", "If", "this", "sNDA", "raises", "the", "argument", "for", "the", "indications", "of", "Actos,", "for", "example,", "reductions", "in", "the", "indications,", "the", "issues", "will", "come", "to", "a", "critical", "path", "like", "as", "I", "mentioned.", "So", "we", "should", "go", "into", "action", "on", "condition", "that", "there", "is", "no", "such", "risk.", "Combination", "therapy", "in", "the", "US", "market", "accounts", "for", "64%", "of", "total", "Actos", "sales.", "(29%", "in", "combination", "with", "SU,", "27%", "Metformin", "and", "8%", "Insulin)", "Regarding", "the", "possibility", "of", "the", "risk", "of", "labeling", "revision,", "International", "Division", "entrusts", "Development", "Division", "with", "final", "decision.", "However,", "just", "to", "be", "sure,", "I", "would", "like", "to", "reconfirm", "that", "this", "sNDA", "dose", "not", "lead", "to", "a", "serious", "situation.", "I", "heard", "that", "TPNA", "R&D", "suggested", "to", "HQ", "and", "is", "getting", "ready", "for", "sNDA", "for", "the", "45mg", "combination", "indications.", "However,", "HQ", "should", "carefully", "judge", "whether", "this", "sNDA", "should", "be", "submitted", "to", "the", "FDA", "or", "not.", "I", "think", "that", "sNDA", "for", "efficacy", "should", "be", "submitted", "only", "when", "there", "is", "no", "risk", "that", "this", "sND", "A", "damages", "the", "current", "labeling.", "According", "to", "the", "results", "of", "PNFP-343,", "combination", "with", "insulin,", "edema", "was", "observed", "more", "often", "than", "Avandia,", "which", "dose", "not", "have", "the", "indication", "for", "combination", "with", "insulin", "and", "CHF", "in", "this", "study", "seems", "to", "be", "dose", "related.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00005583", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupt2290-coots.ucsf.edu/docs/syjf0226" ]

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{ "match_score": 1, "matched_text": "MPDRAP I Leader", "start": 19, "text": "MPDRAP I Leader" }

{ "de": "Was wird im CC erwähnt?", "en": "what is mentioned in the CC?", "es": "¿Qué se menciona en el CC?", "fr": "Qu'est-ce qui est mentionné dans le CC?", "it": "cosa viene menzionato nel CC?" }

[ "CEOs and General Managers of Pharmaceutical Units", "CEOs and general managers of pharmaceutical units" ]

[ "8", "January", "2003", "To:", "MPDRAP", "I", "Leader", "cc:", "CEOs", "and", "General", "Managers", "of", "Pharmaceutical", "Units", "My", "Concerns", "about", "sNDA", "for", "Actos", "45mg", "in", "the", "USA", "(Reconfirmation)", "Pharmaceutical", "International", "Division", "Y.", "Narai", "I", "express", "my", "opinion", "about", "the", "conclusion", "drawn", "at", "MPDRAP", "Committee", "Meeting", "where", "it", "was", "agreed", "that", "sNDA", "to", "obtain", "the", "approval", "of", "the", "45mg", "combination", "indications", "would", "be", "submitted,", "as", "well", "as", "the", "safety", "update", "based", "on", "the", "commitment", "studies.", "As", "you", "know,", "Actos", "is", "the", "essential", "product", "for", "IPNA", "and", "is", "vital", "to", "the", "survival", "of", "TPNA.", "If", "unfavorable", "revisions", "in", "the", "Actos", "labeling", "are", "made,", "it", "invites", "the", "serious", "risk", "to", "Actos", "in", "the", "US.", "TPNA", "is", "now", "under", "attack", "from", "GSK,", "especially", "by", "Avandamet", "and", "is", "eager", "to", "maintain", "their", "market", "share.", "In", "addition", "to", "this", "attack,", "if", "the", "indications", "of", "Actos", "are", "reduced,", "TPNA", "is", "pushed", "into", "critical", "situation.", "This", "issue", "seriously", "damages", "not", "only", "US", "market", "but", "also", "Takeda's", "global", "strategy.", "Therefore,", "HQ", "should", "be", "extremely", "cautious", "about", "the", "issues", "related", "to", "Actos.", "If", "this", "sNDA", "raises", "the", "argument", "for", "the", "indications", "of", "Actos,", "for", "example,", "reductions", "in", "the", "indications,", "the", "issues", "will", "come", "to", "a", "critical", "path", "like", "as", "I", "mentioned.", "So", "we", "should", "go", "into", "action", "on", "condition", "that", "there", "is", "no", "such", "risk.", "Combination", "therapy", "in", "the", "US", "market", "accounts", "for", "64%", "of", "total", "Actos", "sales.", "(29%", "in", "combination", "with", "SU,", "27%", "Metformin", "and", "8%", "Insulin)", "Regarding", "the", "possibility", "of", "the", "risk", "of", "labeling", "revision,", "International", "Division", "entrusts", "Development", "Division", "with", "final", "decision.", "However,", "just", "to", "be", "sure,", "I", "would", "like", "to", "reconfirm", "that", "this", "sNDA", "dose", "not", "lead", "to", "a", "serious", "situation.", "I", "heard", "that", "TPNA", "R&D", "suggested", "to", "HQ", "and", "is", "getting", "ready", "for", "sNDA", "for", "the", "45mg", "combination", "indications.", "However,", "HQ", "should", "carefully", "judge", "whether", "this", "sNDA", "should", "be", "submitted", "to", "the", "FDA", "or", "not.", "I", "think", "that", "sNDA", "for", "efficacy", "should", "be", "submitted", "only", "when", "there", "is", "no", "risk", "that", "this", "sND", "A", "damages", "the", "current", "labeling.", "According", "to", "the", "results", "of", "PNFP-343,", "combination", "with", "insulin,", "edema", "was", "observed", "more", "often", "than", "Avandia,", "which", "dose", "not", "have", "the", "indication", "for", "combination", "with", "insulin", "and", "CHF", "in", "this", "study", "seems", "to", "be", "dose", "related.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00005583", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupt2290-coots.ucsf.edu/docs/syjf0226" ]

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{ "match_score": 1, "matched_text": "CEOs and General Managers of Pharmaceutical Units", "start": 39, "text": "CEOs and General Managers of Pharmaceutical Units" }

{ "de": "kombinationstherapie im us-markt macht aus, wie viel % des gesamten actos-umsatzes.", "en": "combination therapy in the us market accounts for how much % of total actos sales .", "es": "la terapia de combinación en el mercado de nosotros representa cuánto % de las ventas totales de actos.", "fr": "la thérapie combinée sur le marché de nous représente combien de % des ventes totales d'actos.", "it": "la terapia di combinazione nel nostro mercato rappresenta la percentuale delle vendite totali di atti." }

[ "64", "64%" ]

[ "8", "January", "2003", "To:", "MPDRAP", "I", "Leader", "cc:", "CEOs", "and", "General", "Managers", "of", "Pharmaceutical", "Units", "My", "Concerns", "about", "sNDA", "for", "Actos", "45mg", "in", "the", "USA", "(Reconfirmation)", "Pharmaceutical", "International", "Division", "Y.", "Narai", "I", "express", "my", "opinion", "about", "the", "conclusion", "drawn", "at", "MPDRAP", "Committee", "Meeting", "where", "it", "was", "agreed", "that", "sNDA", "to", "obtain", "the", "approval", "of", "the", "45mg", "combination", "indications", "would", "be", "submitted,", "as", "well", "as", "the", "safety", "update", "based", "on", "the", "commitment", "studies.", "As", "you", "know,", "Actos", "is", "the", "essential", "product", "for", "IPNA", "and", "is", "vital", "to", "the", "survival", "of", "TPNA.", "If", "unfavorable", "revisions", "in", "the", "Actos", "labeling", "are", "made,", "it", "invites", "the", "serious", "risk", "to", "Actos", "in", "the", "US.", "TPNA", "is", "now", "under", "attack", "from", "GSK,", "especially", "by", "Avandamet", "and", "is", "eager", "to", "maintain", "their", "market", "share.", "In", "addition", "to", "this", "attack,", "if", "the", "indications", "of", "Actos", "are", "reduced,", "TPNA", "is", "pushed", "into", "critical", "situation.", "This", "issue", "seriously", "damages", "not", "only", "US", "market", "but", "also", "Takeda's", "global", "strategy.", "Therefore,", "HQ", "should", "be", "extremely", "cautious", "about", "the", "issues", "related", "to", "Actos.", "If", "this", "sNDA", "raises", "the", "argument", "for", "the", "indications", "of", "Actos,", "for", "example,", "reductions", "in", "the", "indications,", "the", "issues", "will", "come", "to", "a", "critical", "path", "like", "as", "I", "mentioned.", "So", "we", "should", "go", "into", "action", "on", "condition", "that", "there", "is", "no", "such", "risk.", "Combination", "therapy", "in", "the", "US", "market", "accounts", "for", "64%", "of", "total", "Actos", "sales.", "(29%", "in", "combination", "with", "SU,", "27%", "Metformin", "and", "8%", "Insulin)", "Regarding", "the", "possibility", "of", "the", "risk", "of", "labeling", "revision,", "International", "Division", "entrusts", "Development", "Division", "with", "final", "decision.", "However,", "just", "to", "be", "sure,", "I", "would", "like", "to", "reconfirm", "that", "this", "sNDA", "dose", "not", "lead", "to", "a", "serious", "situation.", "I", "heard", "that", "TPNA", "R&D", "suggested", "to", "HQ", "and", "is", "getting", "ready", "for", "sNDA", "for", "the", "45mg", "combination", "indications.", "However,", "HQ", "should", "carefully", "judge", "whether", "this", "sNDA", "should", "be", "submitted", "to", "the", "FDA", "or", "not.", "I", "think", "that", "sNDA", "for", "efficacy", "should", "be", "submitted", "only", "when", "there", "is", "no", "risk", "that", "this", "sND", "A", "damages", "the", "current", "labeling.", "According", "to", "the", "results", "of", "PNFP-343,", "combination", "with", "insulin,", "edema", "was", "observed", "more", "often", "than", "Avandia,", "which", "dose", "not", "have", "the", "indication", "for", "combination", "with", "insulin", "and", "CHF", "in", "this", "study", "seems", "to", "be", "dose", "related.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00005583", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupt2290-coots.ucsf.edu/docs/syjf0226" ]

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{ "match_score": 1, "matched_text": "64", "start": 1306, "text": "64" }

{ "de": "Was ist der Fälligkeitstermin für die Auswertung der Daten von actos 507?", "en": "What is the due date to evaluate data from actos 507?", "es": "¿Cuál es la fecha de vencimiento para evaluar los datos de actos 507?", "fr": "Quelle est la date limite pour évaluer les données des actos 507?", "it": "Qual è la data di scadenza per la valutazione dei dati da actos 507?" }

[ "August 5" ]

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{ "match_score": 1, "matched_text": "August 5", "start": 141, "text": "August 5" }

{ "de": "wer ist die federführende Verantwortung für die Entwicklung eines zusätzlichen Monitoringplans für actos 508", "en": "who is the lead responsibility for developing additional monitoring plan for actos 508", "es": "quién es el principal responsable de desarrollar un plan de seguimiento adicional para los actos 508", "fr": "qui est responsable au premier chef de l'élaboration d'un plan de surveillance supplémentaire pour les actos 508", "it": "che è la responsabilità principale dello sviluppo di un piano di monitoraggio supplementare per gli atti 508" }

[ "Amy Hagaman", "Amy hagaman" ]

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{ "match_score": 1, "matched_text": "Amy Hagaman", "start": 129, "text": "Amy Hagaman" }

{ "de": "was ist der Fälligkeitstermin für den \"Entwurf der Begründung für actos 508\"?", "en": "what is the due date for \"draft justification for actos 508\" ?", "es": "¿Cuál es la fecha de vencimiento del \"proyecto de justificación de actos 508\"?", "fr": "Quelle est la date d'échéance pour \"projet de justification pour actos 508\"?", "it": "Qual è la data di scadenza per il \"progetto di giustificazione per attos 508\"?" }

[ "August 12", "august 12" ]

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{ "match_score": 1, "matched_text": "August 12", "start": 514, "text": "August 12" }

{ "de": "Wann wurde diese zuletzt aktualisiert?", "en": "when was this last updated ?", "es": "¿Cuándo se actualizó por última vez?", "fr": "Quand a-t-il été mis à jour pour la dernière fois?", "it": "Quando è stata aggiornata l'ultima volta?" }

[ "August 1, 2002", "august 1, 2002" ]

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{ "match_score": 1, "matched_text": "August 1, 2002", "start": 680, "text": "August 1, 2002" }

{ "de": "Welches ist die Kernorganisation von Takeda Pharma Company?", "en": "Which is the core organization of Takeda pharmaceutical Company?", "es": "¿Cuál es la organización principal de Takeda Pharmaceutical Company?", "fr": "Quelle est l'organisation principale de Takeda Pharmaceutical Company?", "it": "Qual è l'organizzazione centrale della Takeda Pharmaceutical Company?" }

[ "Pharmaceutical development Division", "Pharmaceutical Development Division" ]

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{ "match_score": 0.971428572244898, "matched_text": "Pharmaceutical Development Division", "start": 395, "text": "Pharmaceutical development Division" }

{ "de": "Wer hat die einleitenden Bemerkungen gemacht?", "en": "Who made the opening remarks ?", "es": "¿Quién hizo el discurso de apertura?", "fr": "Qui a fait les remarques d'ouverture?", "it": "Chi ha fatto le osservazioni di apertura?" }

[ "Dr. Kitazawa" ]

[ "Ms.", "Wakamatsu,", "Assistant", "manager,", "Dept.", "Strategic", "Development,", "et", "al.", "Attachment:", "NDA", "schedule", "for", "each", "project", "approved", "on", "the", "5th", "GDC", "1.", "Openings", "Remarks", "Dr.", "Kitazawa", "made", "opening", "remarks.", "He", "mentioned", "that", "TAKEDA", "has", "been", "driving", "for", "to", "be", "a", "global", "pharmaceutical", "company", "in", "this", "decade,", "concentrating", "all", "resource", "into", "the", "pharmaceutical", "business,", "under", "the", "clear-cut", "leadership", "of", "the", "CEO.", "Pharmaceutical", "Development", "Division", "is", "a", "core", "organization", "of", "Takeda", "Pharmaceutical", "Company,", "enhancing", "the", "pipeline", "products,", "which", "is", "the", "decisive", "factor", "for", "TAKEDA", "business.", "However,", "in", "the", "present", "condition,", "since", "the", "launch", "of", "Actos", "in", "1999", "there", "are", "no", "new", "products", "launched.", "While", "this", "situation", "is", "critical,", "the", "Pharmaceutical", "Development", "Division", "is", "thought", "to", "be", "conservative", "and", "lack", "of", "challenging", "spirit.", "He", "stated", "that", "his", "mission", "is", "to", "improve", "this", "conservative", "atmosphere", "and", "grow", "challenging", "spirit", "to", "develop", "and", "launch", "the", "new", "products", "earlier", "than", "scheduled.", "Formatted:", "Not", "Hidden", "3.", "MPDRAP-I", "(Diabetes)", "1)", "AD-4833", "Update", "of", "US", "status", "by", "TPNA", "Bladder", "tumor", "observed", "in", "NN622", "study", "As", "for", "the", "bladder", "issues,", "an", "expected", "response", "from", "FDA", "is", "in", "early", "October", "and", "pediatric", "study", "(Actos", "508)", "is", "temporarily", "on", "hold,", "however,", "this", "is", "not", "an", "official", "hold.", "In", "the", "recent", "teleconference", "discussing", "non-clinical", "issues,", "the", "experts", "could", "not", "identify", "any", "rational", "hypothesis", "that", "dual", "PPAR", "agonists", "may", "be", "linked", "to", "bladder", "tumogenesis.", "A", "clinical", "expert", "meeting", "is", "scheduled", "for", "October", "1", "and", "2", "to", "discuss", "how", "to", "screen/monitor", "bladder", "tumors", "in", "long-term", "clinical", "trials,", "since", "FDA", "may", "force", "TPNA", "to", "do", "it.", "Label", "changes", "may", "be", "requested", "by", "FDA", "and", "it", "is", "very", "difficult", "to", "assess", "the", "marketing", "impact", "of", "such", "label", "change", "at", "this", "moment.", "It", "was", "suggested", "to", "prepare", "non-clinical", "\"White", "paper\"", "to", "address", "the", "bladder", "issue.", "US", "commitment", "study", "of", "30mg", "vs.", "45mg", "An", "SNDA", "will", "be", "submitted", "in", "this", "autumn,", "where", "studies", "341,", "342,", "343", "and", "513", "are", "included.", "The", "objectives", "of", "the", "submission", "are", "for", "1)", "a", "safety", "purpose,", "not", "for", "an", "efficacy", "or", "new", "indication", "of", "45mg,", "and", "2)", "an", "update", "of", "oral", "contraceptive", "interaction", "results", "in", "the", "label.", "Timelines", "and", "issues", "on", "Actos", "combination", "projects", "were", "presented.", "Actos-Metformin", "Convenience", "Pack", "is", "expected", "to", "file", "sNDA", "in", "March", "2003", "and", "to", "be", "approved", "in", "September", "2003.", "TPNA", "believes", "stability", "data", "of", "3", "months", "are", "sufficient", "2", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00012574", "Source:", "https://www.indupto442coo02ts.ucsf.edu/docs/Imjf0226", "Produced", "in", "MDL", "on", "09/14/12" ]

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{ "match_score": 1, "matched_text": "Dr. Kitazawa", "start": 156, "text": "Dr. Kitazawa" }

{ "de": "Wann ist das klinische Expertentreffen geplant?", "en": "When is the clinical expert meeting scheduled?", "es": "¿Cuándo está programada la reunión de expertos clínicos?", "fr": "Quand est prévue la réunion d'experts cliniques?", "it": "Quando è prevista la riunione degli esperti clinici?" }

[ "for October 1 and 2.", "October 1 and 2" ]

[ "Ms.", "Wakamatsu,", "Assistant", "manager,", "Dept.", "Strategic", "Development,", "et", "al.", "Attachment:", "NDA", "schedule", "for", "each", "project", "approved", "on", "the", "5th", "GDC", "1.", "Openings", "Remarks", "Dr.", "Kitazawa", "made", "opening", "remarks.", "He", "mentioned", "that", "TAKEDA", "has", "been", "driving", "for", "to", "be", "a", "global", "pharmaceutical", "company", "in", "this", "decade,", "concentrating", "all", "resource", "into", "the", "pharmaceutical", "business,", "under", "the", "clear-cut", "leadership", "of", "the", "CEO.", "Pharmaceutical", "Development", "Division", "is", "a", "core", "organization", "of", "Takeda", "Pharmaceutical", "Company,", "enhancing", "the", "pipeline", "products,", "which", "is", "the", "decisive", "factor", "for", "TAKEDA", "business.", "However,", "in", "the", "present", "condition,", "since", "the", "launch", "of", "Actos", "in", "1999", "there", "are", "no", "new", "products", "launched.", "While", "this", "situation", "is", "critical,", "the", "Pharmaceutical", "Development", "Division", "is", "thought", "to", "be", "conservative", "and", "lack", "of", "challenging", "spirit.", "He", "stated", "that", "his", "mission", "is", "to", "improve", "this", "conservative", "atmosphere", "and", "grow", "challenging", "spirit", "to", "develop", "and", "launch", "the", "new", "products", "earlier", "than", "scheduled.", "Formatted:", "Not", "Hidden", "3.", "MPDRAP-I", "(Diabetes)", "1)", "AD-4833", "Update", "of", "US", "status", "by", "TPNA", "Bladder", "tumor", "observed", "in", "NN622", "study", "As", "for", "the", "bladder", "issues,", "an", "expected", "response", "from", "FDA", "is", "in", "early", "October", "and", "pediatric", "study", "(Actos", "508)", "is", "temporarily", "on", "hold,", "however,", "this", "is", "not", "an", "official", "hold.", "In", "the", "recent", "teleconference", "discussing", "non-clinical", "issues,", "the", "experts", "could", "not", "identify", "any", "rational", "hypothesis", "that", "dual", "PPAR", "agonists", "may", "be", "linked", "to", "bladder", "tumogenesis.", "A", "clinical", "expert", "meeting", "is", "scheduled", "for", "October", "1", "and", "2", "to", "discuss", "how", "to", "screen/monitor", "bladder", "tumors", "in", "long-term", "clinical", "trials,", "since", "FDA", "may", "force", "TPNA", "to", "do", "it.", "Label", "changes", "may", "be", "requested", "by", "FDA", "and", "it", "is", "very", "difficult", "to", "assess", "the", "marketing", "impact", "of", "such", "label", "change", "at", "this", "moment.", "It", "was", "suggested", "to", "prepare", "non-clinical", "\"White", "paper\"", "to", "address", "the", "bladder", "issue.", "US", "commitment", "study", "of", "30mg", "vs.", "45mg", "An", "SNDA", "will", "be", "submitted", "in", "this", "autumn,", "where", "studies", "341,", "342,", "343", "and", "513", "are", "included.", "The", "objectives", "of", "the", "submission", "are", "for", "1)", "a", "safety", "purpose,", "not", "for", "an", "efficacy", "or", "new", "indication", "of", "45mg,", "and", "2)", "an", "update", "of", "oral", "contraceptive", "interaction", "results", "in", "the", "label.", "Timelines", "and", "issues", "on", "Actos", "combination", "projects", "were", "presented.", "Actos-Metformin", "Convenience", "Pack", "is", "expected", "to", "file", "sNDA", "in", "March", "2003", "and", "to", "be", "approved", "in", "September", "2003.", "TPNA", "believes", "stability", "data", "of", "3", "months", "are", "sufficient", "2", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00012574", "Source:", "https://www.indupto442coo02ts.ucsf.edu/docs/Imjf0226", "Produced", "in", "MDL", "on", "09/14/12" ]

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{ "match_score": 0.9500000024999998, "matched_text": "for October 1 and 2 ", "start": 1484, "text": "for October 1 and 2." }

{ "de": "Was ist das Datum, das in den gegebenen Informationen erwähnt wird?", "en": "what is the date mentioned in the given information ?", "es": "¿Cuál es la fecha mencionada en la información dada?", "fr": "Quelle est la date mentionnée dans l'information donnée?", "it": "Qual è la data indicata nelle informazioni fornite?" }

[ "20 April 2006", "20 april 2006" ]

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{ "match_score": 1, "matched_text": "20 April 2006", "start": 36, "text": "20 April 2006" }

{ "de": "Was ist die hier erwähnte Sitzungszeit?", "en": "What is the meeting time mentioned here?", "es": "¿Cuál es el tiempo de reunión mencionado aquí?", "fr": "Quel est le temps de réunion mentionné ici?", "it": "Qual è l'orario di riunione qui menzionato?" }

[ "4:00pm - 5:00pm" ]

[ "Actos", "Pediatric", "Working", "Group", "Date:", "20", "April", "2006", "Time:", "4:00pm", "-", "5:00pm", "Meeting", "Minutes", "Place:", "Meeting", "Room", "403", "Attendees", "Attendees", "Alfonso", "Perez", "-", "Clinical", "Karen", "Kaluzny", "-", "Project", "Management", "X", "Stuart", "Kupfer", "-", "Clinica", "X", "Mary", "Jo", "Pritza", "-", "Regulatory", "X", "Brigit", "Isaacson", "-", "Clinical", "X", "Shari", "Bodnoff", "-", "Medical", "Writing", "X", "Pat", "Schwartz", "-", "Clinical", "Andy", "Roberts", "-", "Medical", "Writing", "X", "Mondira", "Bhattacharya", "-", "Product", "Safety", "X", "Agenda", "Items", "GDC", "Update", "TPC", "stressed", "the", "importance", "of", "the", "ACTOS", "pediatric", "program,", "and", "requested", "that", "the", "preparation", "of", "the", "written", "request", "be", "expedited.", "Next", "Steps", "-", "Developing", "Partial", "Clinical", "Hold", "Removal", "Request", "Document", "A", "meeting", "will", "be", "scheduled", "in", "early", "May", "to", "develop", "the", "overall", "structure", "of", "the", "document.", "In", "addition", "to", "the", "elements", "already", "defined,", "the", "team", "agreed", "that", "the", "following", "should", "be", "added:", "Any", "new", "nonclinical", "data", "regarding", "PPAR", "agonists", "and", "bladder", "safety", "Bladder", "safety", "analysis", "from", "CHICAGO", "study", "(Projected", "database", "lock:", "5", "June", "2006)", "Post-meeting", "note:", "Additional", "safety", "analysis", "from", "ACTOS", "506", "study", "Action", "Items:", "Mondira", "will", "forward", "article", "regarding", "rosiglitazone", "and", "nonclinical", "bladder", "data", "to", "Andy.", "Andy", "will", "request", "a", "literature", "search", "for", "any", "new", "articles", "regarding", "PPARs", "and", "nonclinical", "bladder", "data.", "Mary", "Jo", "will", "follow-up", "with", "David", "Baron", "to", "determine", "if", "he", "is", "aware", "of", "any", "new", "data", "regarding", "PPARs", "and", "bladder", "safety.", "Mary", "Jo", "will", "determine", "if", "the", "FDA", "has", "received", "information", "about", "the", "PROactive", "extension", "and", "the", "second", "KNPC", "study", "being", "done", "to", "fulfill", "EMEA's", "requirements.", "Post-meeting", "note:", "Completed.", "Both", "protocols", "were", "sent", "to", "the", "FDA.", "Andy", "will", "follow-up", "with", "Regulatory", "to", "obtain", "examples", "of", "other", "clinical", "hold", "removal", "request", "documents.", "(Deb", "Yarbrough", "-", "TAK-428,", "Mary", "Jo", "-", "TAK-654)", "Karen", "will", "schedule", "the", "document", "development", "meeting", "for", "the", "second", "week", "of", "May.", "N:/Product", "Development", "and", "Planning/ACTOS/Working", "Groups/Pediatrics/<AUTO>", "Page", "1", "of", "2", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-KUPFES-00716752", "Produced", "in", "MDL", "on", "09/19/12", "Source:", "https://www.indup4885-ooounits.ucsf.edu/docs/nqjf0226" ]

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{ "match_score": 1, "matched_text": "4:00pm - 5:00pm", "start": 56, "text": "4:00pm - 5:00pm" }

{ "de": "Was ist der Ort erwähnt?", "en": "what is the place mentioned ?", "es": "¿Cuál es el lugar mencionado?", "fr": "quel est l'endroit mentionné?", "it": "Qual è il luogo menzionato?" }

[ "Meeting Room 403", "meeting room 403" ]

[ "Actos", "Pediatric", "Working", "Group", "Date:", "20", "April", "2006", "Time:", "4:00pm", "-", "5:00pm", "Meeting", "Minutes", "Place:", "Meeting", "Room", "403", "Attendees", "Attendees", "Alfonso", "Perez", "-", "Clinical", "Karen", "Kaluzny", "-", "Project", "Management", "X", "Stuart", "Kupfer", "-", "Clinica", "X", "Mary", "Jo", "Pritza", "-", "Regulatory", "X", "Brigit", "Isaacson", "-", "Clinical", "X", "Shari", "Bodnoff", "-", "Medical", "Writing", "X", "Pat", "Schwartz", "-", "Clinical", "Andy", "Roberts", "-", "Medical", "Writing", "X", "Mondira", "Bhattacharya", "-", "Product", "Safety", "X", "Agenda", "Items", "GDC", "Update", "TPC", "stressed", "the", "importance", "of", "the", "ACTOS", "pediatric", "program,", "and", "requested", "that", "the", "preparation", "of", "the", "written", "request", "be", "expedited.", "Next", "Steps", "-", "Developing", "Partial", "Clinical", "Hold", "Removal", "Request", "Document", "A", "meeting", "will", "be", "scheduled", "in", "early", "May", "to", "develop", "the", "overall", "structure", "of", "the", "document.", "In", "addition", "to", "the", "elements", "already", "defined,", "the", "team", "agreed", "that", "the", "following", "should", "be", "added:", "Any", "new", "nonclinical", "data", "regarding", "PPAR", "agonists", "and", "bladder", "safety", "Bladder", "safety", "analysis", "from", "CHICAGO", "study", "(Projected", "database", "lock:", "5", "June", "2006)", "Post-meeting", "note:", "Additional", "safety", "analysis", "from", "ACTOS", "506", "study", "Action", "Items:", "Mondira", "will", "forward", "article", "regarding", "rosiglitazone", "and", "nonclinical", "bladder", "data", "to", "Andy.", "Andy", "will", "request", "a", "literature", "search", "for", "any", "new", "articles", "regarding", "PPARs", "and", "nonclinical", "bladder", "data.", "Mary", "Jo", "will", "follow-up", "with", "David", "Baron", "to", "determine", "if", "he", "is", "aware", "of", "any", "new", "data", "regarding", "PPARs", "and", "bladder", "safety.", "Mary", "Jo", "will", "determine", "if", "the", "FDA", "has", "received", "information", "about", "the", "PROactive", "extension", "and", "the", "second", "KNPC", "study", "being", "done", "to", "fulfill", "EMEA's", "requirements.", "Post-meeting", "note:", "Completed.", "Both", "protocols", "were", "sent", "to", "the", "FDA.", "Andy", "will", "follow-up", "with", "Regulatory", "to", "obtain", "examples", "of", "other", "clinical", "hold", "removal", "request", "documents.", "(Deb", "Yarbrough", "-", "TAK-428,", "Mary", "Jo", "-", "TAK-654)", "Karen", "will", "schedule", "the", "document", "development", "meeting", "for", "the", "second", "week", "of", "May.", "N:/Product", "Development", "and", "Planning/ACTOS/Working", "Groups/Pediatrics/<AUTO>", "Page", "1", "of", "2", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-KUPFES-00716752", "Produced", "in", "MDL", "on", "09/19/12", "Source:", "https://www.indup4885-ooounits.ucsf.edu/docs/nqjf0226" ]

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{ "match_score": 1, "matched_text": "Meeting Room 403", "start": 95, "text": "Meeting Room 403" }

{ "de": "Warum wurde vorgeschlagen, nicht-klinisches \"Weißpapier\" vorzubereiten?", "en": "Why was it suggested to prepare non-clinical \"White paper\"?", "es": "¿Por qué se sugirió preparar un \"papel blanco\" no clínico?", "fr": "Pourquoi a-t-on suggéré de préparer un «papier blanc» non clinique?", "it": "Perché è stato suggerito di preparare la \"carta bianca\" non clinica?" }

[ "to address the bladder issue", "to address the bladder issue." ]

[ "Ms.", "Wakamatsu,", "Assistant", "manager,", "Dept.", "Strategic", "Development,", "et", "al.", "Attachment:", "NDA", "schedule", "for", "each", "project", "approved", "on", "the", "5th", "GDC", "1.", "Openings", "Remarks", "Dr.", "Kitazawa", "made", "opening", "remarks.", "He", "mentioned", "that", "TAKEDA", "has", "been", "driving", "for", "to", "be", "a", "global", "pharmaceutical", "company", "in", "this", "decade,", "concentrating", "all", "resource", "into", "the", "pharmaceutical", "business,", "under", "the", "clear-cut", "leadership", "of", "the", "CEO.", "Pharmaceutical", "Development", "Division", "is", "a", "core", "organization", "of", "Takeda", "Pharmaceutical", "Company,", "enhancing", "the", "pipeline", "products,", "which", "is", "the", "decisive", "factor", "for", "TAKEDA", "business.", "However,", "in", "the", "present", "condition,", "since", "the", "launch", "of", "Actos", "in", "1999", "there", "are", "no", "new", "products", "launched.", "While", "this", "situation", "is", "critical,", "the", "Pharmaceutical", "Development", "Division", "is", "thought", "to", "be", "conservative", "and", "lack", "of", "challenging", "spirit.", "He", "stated", "that", "his", "mission", "is", "to", "improve", "this", "conservative", "atmosphere", "and", "grow", "challenging", "spirit", "to", "develop", "and", "launch", "the", "new", "products", "earlier", "than", "scheduled.", "Formatted:", "Not", "Hidden", "3.", "MPDRAP-I", "(Diabetes)", "1)", "AD-4833", "Update", "of", "US", "status", "by", "TPNA", "Bladder", "tumor", "observed", "in", "NN622", "study", "As", "for", "the", "bladder", "issues,", "an", "expected", "response", "from", "FDA", "is", "in", "early", "October", "and", "pediatric", "study", "(Actos", "508)", "is", "temporarily", "on", "hold,", "however,", "this", "is", "not", "an", "official", "hold.", "In", "the", "recent", "teleconference", "discussing", "non-clinical", "issues,", "the", "experts", "could", "not", "identify", "any", "rational", "hypothesis", "that", "dual", "PPAR", "agonists", "may", "be", "linked", "to", "bladder", "tumogenesis.", "A", "clinical", "expert", "meeting", "is", "scheduled", "for", "October", "1", "and", "2", "to", "discuss", "how", "to", "screen/monitor", "bladder", "tumors", "in", "long-term", "clinical", "trials,", "since", "FDA", "may", "force", "TPNA", "to", "do", "it.", "Label", "changes", "may", "be", "requested", "by", "FDA", "and", "it", "is", "very", "difficult", "to", "assess", "the", "marketing", "impact", "of", "such", "label", "change", "at", "this", "moment.", "It", "was", "suggested", "to", "prepare", "non-clinical", "\"White", "paper\"", "to", "address", "the", "bladder", "issue.", "US", "commitment", "study", "of", "30mg", "vs.", "45mg", "An", "SNDA", "will", "be", "submitted", "in", "this", "autumn,", "where", "studies", "341,", "342,", "343", "and", "513", "are", "included.", "The", "objectives", "of", "the", "submission", "are", "for", "1)", "a", "safety", "purpose,", "not", "for", "an", "efficacy", "or", "new", "indication", "of", "45mg,", "and", "2)", "an", "update", "of", "oral", "contraceptive", "interaction", "results", "in", "the", "label.", "Timelines", "and", "issues", "on", "Actos", "combination", "projects", "were", "presented.", "Actos-Metformin", "Convenience", "Pack", "is", "expected", "to", "file", "sNDA", "in", "March", "2003", "and", "to", "be", "approved", "in", "September", "2003.", "TPNA", "believes", "stability", "data", "of", "3", "months", "are", "sufficient", "2", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00012574", "Source:", "https://www.indupto442coo02ts.ucsf.edu/docs/Imjf0226", "Produced", "in", "MDL", "on", "09/14/12" ]

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{ "match_score": 1, "matched_text": "to address the bladder issue", "start": 1803, "text": "to address the bladder issue" }

{ "de": "Wer wird den Artikel über Rosiglitazon und nicht klinische Blasendaten an Andy weiterleiten?", "en": "who will forward the article regarding rosiglitazone and non clinical bladder data to andy ?", "es": "¿Quién enviará el artículo sobre rosiglitazona y datos no clínicos de vejiga a Andy?", "fr": "qui transmettra l'article sur la rosiglitazone et les données non cliniques de la vessie à l'andy?", "it": "chi trasmetterà all' Andy l' articolo relativo ai dati relativi a rosiglitazone e alla vescica non clinica?" }

[ "Mondira" ]

[ "Actos", "Pediatric", "Working", "Group", "Date:", "20", "April", "2006", "Time:", "4:00pm", "-", "5:00pm", "Meeting", "Minutes", "Place:", "Meeting", "Room", "403", "Attendees", "Attendees", "Alfonso", "Perez", "-", "Clinical", "Karen", "Kaluzny", "-", "Project", "Management", "X", "Stuart", "Kupfer", "-", "Clinica", "X", "Mary", "Jo", "Pritza", "-", "Regulatory", "X", "Brigit", "Isaacson", "-", "Clinical", "X", "Shari", "Bodnoff", "-", "Medical", "Writing", "X", "Pat", "Schwartz", "-", "Clinical", "Andy", "Roberts", "-", "Medical", "Writing", "X", "Mondira", "Bhattacharya", "-", "Product", "Safety", "X", "Agenda", "Items", "GDC", "Update", "TPC", "stressed", "the", "importance", "of", "the", "ACTOS", "pediatric", "program,", "and", "requested", "that", "the", "preparation", "of", "the", "written", "request", "be", "expedited.", "Next", "Steps", "-", "Developing", "Partial", "Clinical", "Hold", "Removal", "Request", "Document", "A", "meeting", "will", "be", "scheduled", "in", "early", "May", "to", "develop", "the", "overall", "structure", "of", "the", "document.", "In", "addition", "to", "the", "elements", "already", "defined,", "the", "team", "agreed", "that", "the", "following", "should", "be", "added:", "Any", "new", "nonclinical", "data", "regarding", "PPAR", "agonists", "and", "bladder", "safety", "Bladder", "safety", "analysis", "from", "CHICAGO", "study", "(Projected", "database", "lock:", "5", "June", "2006)", "Post-meeting", "note:", "Additional", "safety", "analysis", "from", "ACTOS", "506", "study", "Action", "Items:", "Mondira", "will", "forward", "article", "regarding", "rosiglitazone", "and", "nonclinical", "bladder", "data", "to", "Andy.", "Andy", "will", "request", "a", "literature", "search", "for", "any", "new", "articles", "regarding", "PPARs", "and", "nonclinical", "bladder", "data.", "Mary", "Jo", "will", "follow-up", "with", "David", "Baron", "to", "determine", "if", "he", "is", "aware", "of", "any", "new", "data", "regarding", "PPARs", "and", "bladder", "safety.", "Mary", "Jo", "will", "determine", "if", "the", "FDA", "has", "received", "information", "about", "the", "PROactive", "extension", "and", "the", "second", "KNPC", "study", "being", "done", "to", "fulfill", "EMEA's", "requirements.", "Post-meeting", "note:", "Completed.", "Both", "protocols", "were", "sent", "to", "the", "FDA.", "Andy", "will", "follow-up", "with", "Regulatory", "to", "obtain", "examples", "of", "other", "clinical", "hold", "removal", "request", "documents.", "(Deb", "Yarbrough", "-", "TAK-428,", "Mary", "Jo", "-", "TAK-654)", "Karen", "will", "schedule", "the", "document", "development", "meeting", "for", "the", "second", "week", "of", "May.", "N:/Product", "Development", "and", "Planning/ACTOS/Working", "Groups/Pediatrics/<AUTO>", "Page", "1", "of", "2", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-KUPFES-00716752", "Produced", "in", "MDL", "on", "09/19/12", "Source:", "https://www.indup4885-ooounits.ucsf.edu/docs/nqjf0226" ]

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{ "match_score": 1, "matched_text": "Mondira", "start": 370, "text": "Mondira" }

{ "de": "Welches Datum ist für die Tagung vorgesehen, um die Gesamtstruktur des Dokuments zu entwickeln?", "en": "What date is the meeting scheduled to develop the overall structure of the document?", "es": "¿En qué fecha está prevista la reunión para desarrollar la estructura general del documento?", "fr": "Quelle est la date prévue pour l'élaboration de la structure générale du document?", "it": "A che data è prevista la riunione per sviluppare la struttura complessiva del documento?" }

[ "in early May" ]

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{ "match_score": 1, "matched_text": "in early May", "start": 665, "text": "in early May" }

{ "de": "Wer stellte einen Umriss der Cohen-Hypothese vor?", "en": "Who presented an outline of the Cohen hypothesis?", "es": "¿Quién presentó un esquema de la hipótesis de Cohen?", "fr": "Qui a présenté un aperçu de l'hypothèse de Cohen?", "it": "Chi ha presentato uno schema dell'ipotesi Cohen?" }

[ "Philip Collett" ]

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{ "match_score": 1, "matched_text": "Philip Collett", "start": 104, "text": "Philip Collett" }

{ "de": "Was ist bei der Entwicklung von Kalkülen von Bedeutung?", "en": "What is significant in the development of calculi?", "es": "¿Qué es significativo en el desarrollo de los cálculos?", "fr": "Qu'est-ce qui est significatif dans le développement des calculs?", "it": "Cosa c'è di significativo nello sviluppo dei calcoli?" }

[ "Raising the pH of male rat urine above 6.5" ]

[ "ACTOS", "FDA", "Response", "Meeting", "August", "12-13,", "2002", "Page", "4", "of", "4", "Highlights", "from", "Cohen", "Hypothesis", "Discussion", ">", "Philip", "Collett", "presented", "an", "outline", "of", "the", "Cohen", "hypothesis", "Male", "rat", "urine", "has", "a", "very", "high", "protein", "content,", "which", "is", "a", "function", "of", "sex", "hormones", "Raising", "the", "pH", "of", "male", "rat", "urine", "above", "6.5", "is", "significant", "in", "the", "development", "of", "calculi", "Because", "rats", "are", "quadropeds,", "they", "do", "not", "eliminate", "calculi", "as", "humans", "do", "The", "correlation", "observed", "in", "Cohen's", "paper", "is", "0.61.", "The", "European", "authorities", "initially", "determined", "this", "to", "be", "quite", "low;", "however,", "Dr.", "Cohen", "authored", "an", "expert", "report", "which", "stated", "that", "the", "0.61", "correlation", "was", "actually", "high,", "as", "calculi", "can", "dissolve", "over", "time.", "In", "summary,", "the", "tumors", "seen", "in", "rats", "were", "due", "to", "the", "presence", "of", "calculi.", "The", "male", "rat", "urine", "milieu", "contributes", "to", "the", "formation", "of", "calculi.", "Because", "rats", "are", "quadropeds,", "they", "do", "not", "eliminate", "calculi", "as", "bipeds", "do.", "Main", "Points", "from", "Takeda", "Europe", "Experience", "Takeda", "Europe", "successfully", "employed", "the", "following", "strategy:", "Defended", "Cohen", "hypothesis,", "despite", "numerous", "challenges", "Stressed", "the", "\"one", "sex,", "one", "species\"", "argument", "Challenged", "authorities", "regarding", "implementing", "monitoring", "plan", "Offered", "to", "conduct", "a", "case", "control", "study", "post-approval", "Highlights", "from", "PPAR", "Agonist", "Discussion", "The", "group", "extensively", "discussed", "many", "aspects", "of", "the", "PPAR", "mechanism", "and", "ultimately", "decided", "to", "not", "address", "mechanistic", "issues", "in", "the", "initial", "FDA", "response.", "However,", "it", "was", "decided", "that", "this", "argument", "should", "be", "developed,", "as", "it", "may", "be", "necessary", "to", "use", "it", "in", "the", "future,", "and", "action", "items", "were", "assigned", "accordingly.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RAMSTM-00487176", "Produced", "in", "MDL", "on", "03/06/13", "Source:", "https://www.indug2/pg-00604s.ucsf.edu/docs/myjf0226" ]

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{ "match_score": 1, "matched_text": "Raising the pH of male rat urine above 6.5", "start": 248, "text": "Raising the pH of male rat urine above 6.5" }

{ "de": "Was ist die Korrelation, die in cohens Papier beobachtet wird?", "en": "What is the correlation observed in cohen's paper?", "es": "¿Cuál es la correlación observada en el papel de Cohen?", "fr": "Quelle est la corrélation observée dans l'article de Cohen?", "it": "Qual è la correlazione osservata nel documento di Cohen?" }

[ "0.61" ]

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{ "match_score": 1, "matched_text": "0.61", "start": 453, "text": "0.61" }

{ "de": "Warum haben Ratten keine Kalküle eliminiert, wie es der Mensch tut?", "en": "Why didn't rats eliminate calculi as humans do?", "es": "¿Por qué las ratas no eliminaron los cálculos como los humanos?", "fr": "Pourquoi les rats n'ont-ils pas éliminé les calculi comme les humains?", "it": "Perché i ratti non eliminano i calcoli come fanno gli umani?" }

[ "Because rats are quadropeds", "Because rats are quadropeds." ]

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{ "match_score": 1, "matched_text": "Because rats are quadropeds", "start": 336, "text": "Because rats are quadropeds" }

{ "de": "Was ist die Vollform von MAA?", "en": "What is the fullform of MAA?", "es": "¿Cuál es la forma completa de MAA?", "fr": "Quelle est la forme complète de l'AAM?", "it": "Qual è la forma completa di MAA?" }

[ "Marketing Authorization Application" ]

[ "Minutes", "from", "Takeda", "Global", "Risk", "Management", "Forum/March", "22,", "2004", "Facilitators:", "Glyn", "Belcher,", "MA,", "PhD,", "MB,", "BCHIR,", "FFPM/", "TEuRD", "Cal", "McNeill,", "MD/", "TGRD", "Attendees:", "Mondira", "Bhattacharya", "MD,", "David", "Baron", "MD,", "Al", "Dietz", "MD,", "Barbara", "Hendrickson", "MD,", "Doug", "Joseph", "PharmD,", "Ron", "Law", "MD,", "Constance", "Kasprzak", "PharmD,", "Anna", "Lee", "MID,", "Olga", "Minkov", "BS", "MPN,", "Alfonso", "Perez", "MD,", "Jeremy", "Repp", "BIE,", "Mick", "Roebel", "PhD,", "Stephen", "Sainati", "MD,", "Claire", "Thom", "PharmD,", "Bill", "Welder", "MD", "EU", "Perspective", "Glyn", "Belcher", "Risk", "Management", "Identification", "of", "potential", "risk", "Clarification", "of", "risk", "Measurement", "of", "risk", "More", "extensive", "than", "risk", "minimization", "Should", "be", "done", "by", "Pharmacovigilance", "in", "Company.", "Risk", "Management", "starts", "during", "preclinical->", "clinical", "development", ">", "marketing", "Risk", "management", "by", "pharmacovigilance", "in", "company:", "1)", "Pre-clinical->Every", "EU", "country", "sends", "in", "an", "Investigational", "Medicinal", "Product", "(IMP)", "documentation", "much", "like", "the", "IND", "which", "reviews", "preclinical", "safety", "signals", "and", "includes", "a", "plan", "on", "how", "to", "measure", "these", "safety", "signals", "in", "a", "clinical", "trial", "Includes", "specific", "attempts", "during", "clinical", "trials", "to", "clarify", "signals", "2)", "Clinical", "trial->yearly", "IMP", "safety", "report", "(global)", "will", "be", "required", "from", "May", "'04", "onwards", "and", "includes", "all", "safety", "data", "in", "a", "year", "including", "nonclinical", "safety", "data.", "Regulators", "expect", "company", "to", "tell", "them", "what", "the", "problem", "is.", "Requires", "unblinding", "of", "serious", "unexpected", "reactions", "Includes", "Postmarketing", "commitments", "3)", "MAA", "(Marketing", "Authorization", "Application)", "=", "equivalent", "to", "NDA.", "As", "part", "of", "dossier,", "submit", "a", "risk", "management", "plan", "within", "one", "year.", "Risk", "management", "plan", "includes", "what", "you", "can", "say", "about", "safety", "of", "the", "drug", "and", "what", "you", "have", "not", "managed", "to", "clarify:", "more", "proactive", "in", "delineating", "what", "problems", "you", "know", "vs", "what", "you", "don't", "know", "Includes", "plans", "on", "further", "trials/studies", "to", "be", "done", "EXHIBIT", "Takeda", "Forum", "Risk", "Management", "webbies'", "Bhattacharya", "March", "22,", "2004", "7-12", "-", "13", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-BAROND-00208931", "Produced", "in", "MDL", "on", "09/02/12", "Source:", "https://www.indusor56-oocots.ucsf.edu/docs/gmjf0226" ]

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{ "match_score": 1, "matched_text": "Marketing Authorization Application", "start": 1393, "text": "Marketing Authorization Application" }

{ "de": "Welches Forum wird in diesem Dokument erwähnt?", "en": "Which forum is mentioned in this document?", "es": "¿Qué foro se menciona en este documento?", "fr": "Quel forum est mentionné dans ce document?", "it": "Quale forum è menzionato in questo documento?" }

[ "Takeda Global Risk Management Forum", "Takeda Global Risk Management Forum/March 22, 2004" ]

[ "Minutes", "from", "Takeda", "Global", "Risk", "Management", "Forum/March", "22,", "2004", "Facilitators:", "Glyn", "Belcher,", "MA,", "PhD,", "MB,", "BCHIR,", "FFPM/", "TEuRD", "Cal", "McNeill,", "MD/", "TGRD", "Attendees:", "Mondira", "Bhattacharya", "MD,", "David", "Baron", "MD,", "Al", "Dietz", "MD,", "Barbara", "Hendrickson", "MD,", "Doug", "Joseph", "PharmD,", "Ron", "Law", "MD,", "Constance", "Kasprzak", "PharmD,", "Anna", "Lee", "MID,", "Olga", "Minkov", "BS", "MPN,", "Alfonso", "Perez", "MD,", "Jeremy", "Repp", "BIE,", "Mick", "Roebel", "PhD,", "Stephen", "Sainati", "MD,", "Claire", "Thom", "PharmD,", "Bill", "Welder", "MD", "EU", "Perspective", "Glyn", "Belcher", "Risk", "Management", "Identification", "of", "potential", "risk", "Clarification", "of", "risk", "Measurement", "of", "risk", "More", "extensive", "than", "risk", "minimization", "Should", "be", "done", "by", "Pharmacovigilance", "in", "Company.", "Risk", "Management", "starts", "during", "preclinical->", "clinical", "development", ">", "marketing", "Risk", "management", "by", "pharmacovigilance", "in", "company:", "1)", "Pre-clinical->Every", "EU", "country", "sends", "in", "an", "Investigational", "Medicinal", "Product", "(IMP)", "documentation", "much", "like", "the", "IND", "which", "reviews", "preclinical", "safety", "signals", "and", "includes", "a", "plan", "on", "how", "to", "measure", "these", "safety", "signals", "in", "a", "clinical", "trial", "Includes", "specific", "attempts", "during", "clinical", "trials", "to", "clarify", "signals", "2)", "Clinical", "trial->yearly", "IMP", "safety", "report", "(global)", "will", "be", "required", "from", "May", "'04", "onwards", "and", "includes", "all", "safety", "data", "in", "a", "year", "including", "nonclinical", "safety", "data.", "Regulators", "expect", "company", "to", "tell", "them", "what", "the", "problem", "is.", "Requires", "unblinding", "of", "serious", "unexpected", "reactions", "Includes", "Postmarketing", "commitments", "3)", "MAA", "(Marketing", "Authorization", "Application)", "=", "equivalent", "to", "NDA.", "As", "part", "of", "dossier,", "submit", "a", "risk", "management", "plan", "within", "one", "year.", "Risk", "management", "plan", "includes", "what", "you", "can", "say", "about", "safety", "of", "the", "drug", "and", "what", "you", "have", "not", "managed", "to", "clarify:", "more", "proactive", "in", "delineating", "what", "problems", "you", "know", "vs", "what", "you", "don't", "know", "Includes", "plans", "on", "further", "trials/studies", "to", "be", "done", "EXHIBIT", "Takeda", "Forum", "Risk", "Management", "webbies'", "Bhattacharya", "March", "22,", "2004", "7-12", "-", "13", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-BAROND-00208931", "Produced", "in", "MDL", "on", "09/02/12", "Source:", "https://www.indusor56-oocots.ucsf.edu/docs/gmjf0226" ]

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{ "match_score": 1, "matched_text": "Takeda Global Risk Management Forum", "start": 13, "text": "Takeda Global Risk Management Forum" }

{ "de": "Wie lautet das ausgestellte Datum dieses Dokuments?", "en": "What is the issued date of this document?", "es": "¿Cuál es la fecha de publicación de este documento?", "fr": "Quelle est la date de publication de ce document?", "it": "Qual è la data di rilascio di questo documento?" }

[ "august 13, 2002", "August 13, 2002" ]

[ "107", "FDA", "Conference", "Call:", "August", "13,", "2002", "PENGAD", "800-631-698", "EXHIBIT", "FDA", "Personnel:", "Jeri", "El-Hage,", "Ph.D.,", "Toxicology", "Team", "Leader", "Jena", "Weber,", "Project", "Manager", "TPNA", "Personnel:", "David", "Baron,", "Ph.D.,", "Director,", "Nonclinical", "Safety", "and", "Efficacy", "Janet", "Haskins,", "Manager,", "Regulatory", "Affairs", "Pat", "Frank,", "Ph.D.,", "TPNA", "Consultant", "This", "teleconference", "was", "held", "as", "a", "follow-up", "to", "a", "discussion", "between", "TPNA", "and", "the", "Agency", "on", "July", "31,", "2002.", "The", "purpose", "of", "this", "call", "was", "so", "that", "Dr.", "El-Hage", "could", "expand", "upon", "the", "nonclinical", "data", "related", "to", "dual", "PPAR", "agonists", "that", "were", "discussed", "with", "TPNA", "on", "July", "31,", "2002.", "Dr.", "El-Hage", "informed", "TPNA", "that", "in", "standard", "2-year", "rat", "and", "mouse", "bioassay", "studies,", "several", "other", "dual", "PPAR", "agonists", "were", "shown", "to", "cause", "transitional", "cell", "tumors", "in", "the", "bladder", "and", "kidneys", "of", "male", "and", "female", "rats", "and", "male", "mice.", "Therefore,", "the", "Division", "is", "considering", "the", "relevance", "of", "these", "findings", "to", "this", "pharmaceutical", "class", "of", "drugs.", "She", "also", "noted", "that", "in", "follow-up", "unspecified", "mechanistic", "studies", "of", "the", "other", "dual", "PPAR", "agonists,", "no", "evidence", "of", "irritation", "by", "crystalluria", "or", "calculi", "was", "noted.", "Dr.", "El-Hage", "then", "described", "a", "tumor", "promoter-model", "study", "that", "was", "conducted", "by", "another", "sponsor", "in", "which", "pioglitazone", "was", "administered.", "The", "study", "was", "designed", "as", "follows:", ".", "BBN", "was", "given", "to", "male", "Fisher", "rats", "in", "their", "drinking", "water", "for", "four", "weeks.", "Four", "groups", "were", "designated:", ".", "Pioglitazone", "40", "mg/kg/day", "after", "BBN", "The", "study", "compound", "plus", "BBN", "(No", "dosages", "were", "specified,", "but", "Dr.", "El-Hage", "noted", "that", "multiple", "dosages", "were", "studied", "and", "the", "high", "dose", "was", "designed", "to", "be", "\"equivalent\"", "to", "40", "mg/kg", "pioglitazone", ")", "The", "negative", "control", "group", "received", "BBN", "only.", ".", "The", "positive", "control", "group", "received", "uracil.", "Duration", "of", "daily", "dosing", "was", "32-weeks", "after", "BBN.", "Results:", ".", "85%", "of", "the", "animals", "in", "the", "pioglitazone", "and", "the", "other", "sponsor's", "compound", "groups", "had", "tumor", "formation.", "Calculi", "formation", "was", "not", "confirmed", "in", "either", "group,", "but", "was", "looked", "for", "using", "unspecified", "methodology", "15%", "of", "the", "animals", "in", "the", "negative", "control", "group", "had", "tumor", "formation,", "while", "approximately", "50%", "of", "the", "positive", "control", "group", "presented", "tumors", "in", "the", "presence", "of", "calculi", "formation", "(uracil).", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-NAUGHP-00080811", "Source:", "https://www.indup53720boots.ucsf.edu/docs/jsjf0226" ]

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{ "match_score": 0.9333333377777775, "matched_text": "August 13, 2002", "start": 25, "text": "august 13, 2002" }

{ "de": "Wer ist der Direktor für nichtklinische Sicherheit und Wirksamkeit?", "en": "Who is the Director of Nonclinical Safety and Efficacy?", "es": "¿Quién es el Director de Seguridad y Eficacia No Clínica?", "fr": "Qui est le directeur de la sécurité et de l'efficacité non cliniques?", "it": "Chi è il Direttore di Sicurezza ed Efficacia Non Clinica?" }

[ "David baron", "David Baron" ]

[ "107", "FDA", "Conference", "Call:", "August", "13,", "2002", "PENGAD", "800-631-698", "EXHIBIT", "FDA", "Personnel:", "Jeri", "El-Hage,", "Ph.D.,", "Toxicology", "Team", "Leader", "Jena", "Weber,", "Project", "Manager", "TPNA", "Personnel:", "David", "Baron,", "Ph.D.,", "Director,", "Nonclinical", "Safety", "and", "Efficacy", "Janet", "Haskins,", "Manager,", "Regulatory", "Affairs", "Pat", "Frank,", "Ph.D.,", "TPNA", "Consultant", "This", "teleconference", "was", "held", "as", "a", "follow-up", "to", "a", "discussion", "between", "TPNA", "and", "the", "Agency", "on", "July", "31,", "2002.", "The", "purpose", "of", "this", "call", "was", "so", "that", "Dr.", "El-Hage", "could", "expand", "upon", "the", "nonclinical", "data", "related", "to", "dual", "PPAR", "agonists", "that", "were", "discussed", "with", "TPNA", "on", "July", "31,", "2002.", "Dr.", "El-Hage", "informed", "TPNA", "that", "in", "standard", "2-year", "rat", "and", "mouse", "bioassay", "studies,", "several", "other", "dual", "PPAR", "agonists", "were", "shown", "to", "cause", "transitional", "cell", "tumors", "in", "the", "bladder", "and", "kidneys", "of", "male", "and", "female", "rats", "and", "male", "mice.", "Therefore,", "the", "Division", "is", "considering", "the", "relevance", "of", "these", "findings", "to", "this", "pharmaceutical", "class", "of", "drugs.", "She", "also", "noted", "that", "in", "follow-up", "unspecified", "mechanistic", "studies", "of", "the", "other", "dual", "PPAR", "agonists,", "no", "evidence", "of", "irritation", "by", "crystalluria", "or", "calculi", "was", "noted.", "Dr.", "El-Hage", "then", "described", "a", "tumor", "promoter-model", "study", "that", "was", "conducted", "by", "another", "sponsor", "in", "which", "pioglitazone", "was", "administered.", "The", "study", "was", "designed", "as", "follows:", ".", "BBN", "was", "given", "to", "male", "Fisher", "rats", "in", "their", "drinking", "water", "for", "four", "weeks.", "Four", "groups", "were", "designated:", ".", "Pioglitazone", "40", "mg/kg/day", "after", "BBN", "The", "study", "compound", "plus", "BBN", "(No", "dosages", "were", "specified,", "but", "Dr.", "El-Hage", "noted", "that", "multiple", "dosages", "were", "studied", "and", "the", "high", "dose", "was", "designed", "to", "be", "\"equivalent\"", "to", "40", "mg/kg", "pioglitazone", ")", "The", "negative", "control", "group", "received", "BBN", "only.", ".", "The", "positive", "control", "group", "received", "uracil.", "Duration", "of", "daily", "dosing", "was", "32-weeks", "after", "BBN.", "Results:", ".", "85%", "of", "the", "animals", "in", "the", "pioglitazone", "and", "the", "other", "sponsor's", "compound", "groups", "had", "tumor", "formation.", "Calculi", "formation", "was", "not", "confirmed", "in", "either", "group,", "but", "was", "looked", "for", "using", "unspecified", "methodology", "15%", "of", "the", "animals", "in", "the", "negative", "control", "group", "had", "tumor", "formation,", "while", "approximately", "50%", "of", "the", "positive", "control", "group", "presented", "tumors", "in", "the", "presence", "of", "calculi", "formation", "(uracil).", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-NAUGHP-00080811", "Source:", "https://www.indup53720boots.ucsf.edu/docs/jsjf0226" ]

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{ "match_score": 0.9090909173553712, "matched_text": "David Baron", "start": 171, "text": "David baron" }

{ "de": "Wie lange dauert die tägliche Dosierung?", "en": "What is the duration of daily dosing?", "es": "¿Cuál es la duración de la dosis diaria?", "fr": "Quelle est la durée de l'administration quotidienne?", "it": "Qual è la durata della somministrazione giornaliera?" }

[ "32-weeks", "32-weeks after BBN." ]

[ "107", "FDA", "Conference", "Call:", "August", "13,", "2002", "PENGAD", "800-631-698", "EXHIBIT", "FDA", "Personnel:", "Jeri", "El-Hage,", "Ph.D.,", "Toxicology", "Team", "Leader", "Jena", "Weber,", "Project", "Manager", "TPNA", "Personnel:", "David", "Baron,", "Ph.D.,", "Director,", "Nonclinical", "Safety", "and", "Efficacy", "Janet", "Haskins,", "Manager,", "Regulatory", "Affairs", "Pat", "Frank,", "Ph.D.,", "TPNA", "Consultant", "This", "teleconference", "was", "held", "as", "a", "follow-up", "to", "a", "discussion", "between", "TPNA", "and", "the", "Agency", "on", "July", "31,", "2002.", "The", "purpose", "of", "this", "call", "was", "so", "that", "Dr.", "El-Hage", "could", "expand", "upon", "the", "nonclinical", "data", "related", "to", "dual", "PPAR", "agonists", "that", "were", "discussed", "with", "TPNA", "on", "July", "31,", "2002.", "Dr.", "El-Hage", "informed", "TPNA", "that", "in", "standard", "2-year", "rat", "and", "mouse", "bioassay", "studies,", "several", "other", "dual", "PPAR", "agonists", "were", "shown", "to", "cause", "transitional", "cell", "tumors", "in", "the", "bladder", "and", "kidneys", "of", "male", "and", "female", "rats", "and", "male", "mice.", "Therefore,", "the", "Division", "is", "considering", "the", "relevance", "of", "these", "findings", "to", "this", "pharmaceutical", "class", "of", "drugs.", "She", "also", "noted", "that", "in", "follow-up", "unspecified", "mechanistic", "studies", "of", "the", "other", "dual", "PPAR", "agonists,", "no", "evidence", "of", "irritation", "by", "crystalluria", "or", "calculi", "was", "noted.", "Dr.", "El-Hage", "then", "described", "a", "tumor", "promoter-model", "study", "that", "was", "conducted", "by", "another", "sponsor", "in", "which", "pioglitazone", "was", "administered.", "The", "study", "was", "designed", "as", "follows:", ".", "BBN", "was", "given", "to", "male", "Fisher", "rats", "in", "their", "drinking", "water", "for", "four", "weeks.", "Four", "groups", "were", "designated:", ".", "Pioglitazone", "40", "mg/kg/day", "after", "BBN", "The", "study", "compound", "plus", "BBN", "(No", "dosages", "were", "specified,", "but", "Dr.", "El-Hage", "noted", "that", "multiple", "dosages", "were", "studied", "and", "the", "high", "dose", "was", "designed", "to", "be", "\"equivalent\"", "to", "40", "mg/kg", "pioglitazone", ")", "The", "negative", "control", "group", "received", "BBN", "only.", ".", "The", "positive", "control", "group", "received", "uracil.", "Duration", "of", "daily", "dosing", "was", "32-weeks", "after", "BBN.", "Results:", ".", "85%", "of", "the", "animals", "in", "the", "pioglitazone", "and", "the", "other", "sponsor's", "compound", "groups", "had", "tumor", "formation.", "Calculi", "formation", "was", "not", "confirmed", "in", "either", "group,", "but", "was", "looked", "for", "using", "unspecified", "methodology", "15%", "of", "the", "animals", "in", "the", "negative", "control", "group", "had", "tumor", "formation,", "while", "approximately", "50%", "of", "the", "positive", "control", "group", "presented", "tumors", "in", "the", "presence", "of", "calculi", "formation", "(uracil).", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-NAUGHP-00080811", "Source:", "https://www.indup53720boots.ucsf.edu/docs/jsjf0226" ]

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{ "match_score": 1, "matched_text": "32-weeks", "start": 1703, "text": "32-weeks" }

{ "de": "Wer hat den CEO am 6. August aktualisiert?", "en": "Who updated the CEO on August 6?", "es": "¿Quién actualizó el CEO el 6 de agosto?", "fr": "Qui a mis à jour le PDG le 6 août?", "it": "Chi ha aggiornato il CEO il 6 agosto?" }

[ "Mr. Saito" ]

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{ "match_score": 1, "matched_text": "Mr. Saito", "start": 542, "text": "Mr. Saito" }

{ "de": "Bis wann sollte TPNA einen Überblick über die Antwort auf TCI senden?", "en": "By when should TPNA send outline of response to TCI ?", "es": "¿Para cuándo debe TPNA enviar el esquema de respuesta a TCI?", "fr": "Quand l'ACPT devrait-elle envoyer un aperçu de la réponse à l'ICT?", "it": "Entro quando il TPNA dovrebbe inviare una descrizione della risposta al TCI?" }

[ "August 19", "by August 19" ]

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{ "match_score": 1, "matched_text": "August 19", "start": 1154, "text": "August 19" }

{ "de": "Wann wird Mr. Saito dem CEO einen Überblick geben?", "en": "When will Mr. Saito present outline to CEO?", "es": "¿Cuándo presentará el Sr. Saito un esquema al CEO?", "fr": "Quand M. Saito présentera-t-il les grandes lignes au PDG?", "it": "Quando il signor Saito presenterà il profilo all'amministratore delegato?" }

[ "August 20", "on August 20" ]

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