FrancophonIA/ELRC3.0 huggingface dataset:
English: The free drug AUC/MIC for the sum of TA2 subcomponents for Teicoplanin Hospira was within 2% of the Targocid value and the totality of the pre-clinical MIC studies combined with the mouse thigh study and the identical bactericidal serum titres give re-assurance that the microbiological activity of the two products is the same and that pharmacodynamically, the two products can be considered equivalent.
Maltese: L-AUC/MIC liberi tal-mediċina għat-total ta' subkomponenti TA2 għal Teicoplanin Hospira kienu fil-limitu ta' 2% tal-valur ta' Targocid u t-totalità tal-istudji MIC prekliniċi flimkien mal-istudju dwar il-koxxa tal-ġurdien u t-titri tas-serum batteriċidi identiċi jagħtu assigurazzjoni mill-ġdid li l-attività mikrobijoloġika taż-żewġ prodotti hija l-istess u li mil-lat farmakodinamiku, iż-żewġ prodotti jistgħu jitqiesu ekwivalenti.
English: As the CHMP considered that free AUC is the most important PK parameter and that the dominant pharmacodynamic driver of microbiological and clinical outcome is AUC/MIC, the Applicant concluded that the most important PK/PD parameter for assessing microbiological and clinical outcome is the free AUC/MIC.
Maltese: Minħabba li s-CHMP kkunsidra li l-AUC libera hija l-parametru PK l-aktar importanti u li l-ixprunatur farmakodinamiku dominanti ta' eżitu mikrobijoloġiku u kliniku huwa AUC/MIC, l-Applikant ikkonkluda li l-aktar parametru PK/PD importanti għall-evalwazzjoni tal-eżitu mikrobijoloġiku u kliniku huwa l-AUC/MIC liberi.
English: The Applicant concluded that no additional clinical data are required.
Maltese: L-Applikant ikkonkluda li m'hemmx ħtieġa ta' aktar dejta klinika.
English: The CHMP noted the data comparing the PK, PDD and safety of Teicoplanin Hospira and the originator.
Maltese: Is-CHMP nnota d-dejta li tqabbel il-PK, il-PDD u s-sigurtà ta' Teicoplanin Hospira mal-oriġinatur.
English: Ground 3: Furthermore the submitted additional non-clinical and serum bactericidal data are not considered sufficient to adequately demonstrate that Teicoplanin Hospira is a generic of the innovator Targocid
Maltese: Raġuni 3: Barra minn hekk id-dejta addizzjonali mhux klinika u d-dejta batteriċida tas-serum sottomessa mhijiex meqjusa suffiċjenti sabiex turi b'mod adegwat li Teicoplanin Hospira huwa ġeneriku tal-innovatur Targocid
English: The CHMP endorsed the answer of the Applicant, from a pharmacodynamic point of view, free AUC is the most important PK parameter.
Maltese: Is-CHMP approva t-tweġiba tal-Applikant, minn perspettiva farmakodinamika, l-AUC libera hija l-aktar parametru PK importanti.
English: In conclusion, the CHMP considers that the difference in concentration of the glycopeptide subcomponents precludes Teicoplanin Hospira being a considered a generic of Targocid, despite the composition being in line with the JP monograph and the draft Ph.Eur monograph.
Maltese: Fl-aħħar nett, is-CHMP jikkunsidra li d-differenza fil-konċentrazzjoni tas-subkomponenti glikopeptidi tipprekludi li Teicoplanin Hospira jitqies bħala ġeneriku ta' Targocid, minkejja li lkompożizzjoni hija konformi mal-monografu JP u l-abbozz ta' monografu Ph.Eur.
English: Content (concentration)
Maltese: Isem (Ivvintat)
English: Both products include the same subcomponents and despite differences in the subcomponent ratios, both comply with the European Pharmacopoeia (Ph.Eur.)
Maltese: Iż-żewġ prodotti jinkludu l-istess subkomponenti u minkejja differenzi fil-proporzjonijiet tas-subkomponenti, it-tnejn jikkonformaw mal-monografu tal-Farmakopea Ewropea (Ph.Eur.).
English: However, AUC 0-tlast and AUC 0-inf were lower for Teicoplanin Hospira, indicating that PK equivalence was not shown for the total (bound plus unbound) drug exposure.
Maltese: Madankollu, l-AUC 0-tlast u l-AUC 0-inf kienu aktar baxxi għal Teicoplanin Hospira, li jindika li l-ekwivalenza PK ma ntwerietx għall-espożizzjoni totali (marbuta u mhux marbuta) tal-mediċina.
English: The half- lives of the TA2 components correlates to their lipophilicity, and because Teicoplanin Hospira has a lower proportional content of subcomponents with a longer half-life and a higher proportion with a shorter half-life, the overall elimination of total teicoplanin is faster, and the resulting AUC is lower.
Maltese: Il-half-lives talkomponenti TA2 jikkorrispondu għal-lipofiliċità tagħhom u minħabba li Teicoplanin Hospira għandu kontenut ta' subkomponenti proporzjonali aktar baxx b'half-life itwal u proporzjon ogħla b'half-life iqsar, leliminazzjoni globali ta' teicoplanin totali hija aktar rapida, u l-AUC li tirriżulta hija aktar baxxa.
English: In particular, the non-protein bound kinetics of the sub-components of teicoplanin that contribute to its activity (TA21-5) was examined.
Maltese: B'mod partikolari, ġiet eżaminata l-kinetika mhux marbuta mal-proteini tas-subkomponenti ta' teicoplanin li jikkontribwixxu għall-attività tiegħu (TA21-5).
English: The pharmacokinetics of teicoplanin has been determined for both the total complex and for the individual components and analyses of the subcomponents confirmed that the pharmacokinetics of the individual TA2 subcomponents are the same for Teicoplanin Hospira and Targocid.
Maltese: Il-farmakokinetika ta' teicoplanin ġiet iddeterminata kemm għall-kumpless totali kif ukoll għall-komponenti individwali u analiżijiet tas-subkomponenti kkonfermaw li l-farmakokinetika tas-subkomponenti TA2 individwali hija l-istess għal Teicoplanin Hospira u Targocid.
English: The Applicant considered the AUC/MIC ratio individually for all 5 subcomponents, for the free drug, as teicoplanin is extensively protein bound, and the biological activity of the preparation mainly results from the free drug component.
Maltese: L-Applikant ikkunsidra l-proporzjon AUC/MIC individwalment għall-5 subkomponenti kollha, għall-mediċina libera, minħabba li teicoplanin huwa marbut b'mod estensiv malproteini, u l-attività bijoloġika tal-preparazzjoni tirriżulta l-aktar mill-komponent tal-mediċina libera.
English: The CHMP requested the Applicant to further discuss their claim that Teicoplanin Hospira is a generic of Targocid.
Maltese: Is-CHMP talab lillApplikant sabiex ikompli jiddiskuti d-dikjarazzjoni tiegħu li Teicoplanin Hospira huwa ġeneriku ta' Targocid.
English: The results show that free drug for each teicoplanin subcomponent was similar.
Maltese: Irriżultati juru li l-mediċina libera għal kull subkomponent ta' teicoplanin kienet simili.
English: - Teicoplanin Hospira does not meet the originator specifications with respect to the individual glycopeptides subcomponents and has shown to be bio-inequivalent to the originator
Maltese: - Teicoplanin Hospira ma jissodisfax l-ispeċifikazzjonijiet tal-oriġinatur fir-rigward tas-subkomponenti glikopeptidi individwali u wera li mhuwiex bijoekwivalenti għall-oriġinatur
English: The Applicant examined both available active drug (free AUC) and whole drug and free AUC/MIC, concluding that Teicoplanin Hospira is at least as efficacious as Targocid.
Maltese: L-Applikant eżamina kemm il-mediċina libera disponibbli (AUC libera) u l-mediċina sħiħa u AUC/MIC liberi, u wasal għall-konklużjoni li Teicoplanin Hospira huwa mill-inqas effikaċi daqs Targocid.
English: The CHMP was also of the opinion that the study conducted by the Applicant did not demonstrate bioequivalence between Teicoplanin Hospira and Targocid and that the MIC studies are not sensitive enough to detect differences between the two products in the case of teicoplanin, since in vitro anti-bacterial activity is independent of lipophilicity, tissue distribution and clearance of the subcomponents, i.e. differences in systemic exposure.
Maltese: MIC mhumiex sensittivi biżżejjed biex isibu differenzi bejn iż-żewġ prodotti fil-każ ta' teicoplanin, minħabba li l-attività antibatterika in vitro hija indipendenti mil-lipofiliċità, mid-distribuzzjoni tat-tessut u mit-tneħħija tas-subkomponenti, jiġifieri differenzi fl-espożizzjoni sistematika.
English: The Applicant considered that the PK results for whole teicoplanin demonstrated that Cmax and Tmax of Teicoplanin Hospira and Targocid were essentially similar, and the 90% CI for Cmax was within the acceptance range for bioequivalence.
Maltese: L-Applikant ikkunsidra li r-riżultati PK għal teicoplanin sħiħ urew li s-Cmax u t-Tmax ta' Teicoplanin Hospira u Targocid kienu essenzjalment l-istess, u s-CI ta' 90% għas-Cmax kien fil-limiti tal-medda ta' aċċettazzjoni għall-bijoekwivalenza.
English: Accidental overdosing showed no adverse events or abnormalities.
Maltese: Doża eċċessiva aċċidentali ma wriet l-ebda avveniment avvers jew anormalità.
English: Therefore, the Applicant considers Teicoplanin Hospira to be a generic of Targocid.
Maltese: Għaldaqstant, l-Applikant iqis li Teicoplanin Hospira huwa ġeneriku ta' Targocid.
English: The Applicant is therefore requested to further justify that Teicoplanin Hospira is a generic of Targocid in writing and/or at an Oral Explanation in light of the CHMP opinion.“ The Applicant decided to address the List of Outstanding Issues during an oral explanation.
Maltese: L-Applikant huwa għalhekk mitlub li jiġġustifika aktar li Teicoplanin Hospira huwa ġeneriku ta' Targocid bil-miktub u/jew waqt Spjegazzjoni Orali fid-dawl tal-opinjoni tas-CHMP.“ LApplikant iddeċieda li jindirizza l-Lista ta' Kwistjonijiet Pendenti waqt spjegazzjoni orali.
English: The CHMP assessed the studies and concluded that the MIC results were similar between Teicoplanin Hospira and the originator and that no difference in antibacterial activity or in effectiveness was observed.
Maltese: Is-CHMP evalwa l-istudji u kkonkluda li r-riżultati MIC kienu simili bejn Teicoplanin Hospira u l-oriġinatur u li ma ġiet osservata l-ebda differenza fl-attività antibatterika jew fl-effikaċja.
English: The Applicant then defined the active ingredient by referring to the INN and the pharmacopoeial monographs, concluding that Teicoplanin Hospira meets all of the criteria necessary to define it as a generic of the originator product.
Maltese: L-Applikant imbagħad iddefinixxa l-ingredjent attiv billi rrefera għall-INN u l-monografi farmakopeiċi, u kkonkluda li Teicoplanin Hospira jissodisfa l-kriterji kollha meħtieġa li jiddefinixxuh bħala ġeneriku tal-prodott oriġinatur.
English: Accordingly, the Applicant argued that the sum of free AUC/MIC of the subcomponents is substantiating comparable activity between the generic and the innovator.
Maltese: Għalhekk, l-Applikant argumenta li t-total tal-AUC/MIC liberi tas-subkomponenti huwa s-sostanzjar tal-attività komparabbli bejn il-ġeneriku u l-innovatur.
English: The Applicant believes that the sum of the individual ratios determined for each subcomponent is essentially the same as for the total teicoplanin.
Maltese: LApplikant jemmen li t-total tal-proporzjonijiet individwali ddeterminati għal kull subkomponent huwa essenzjalment l-istess bħal dak tat-teicoplanin totali.
English: The Applicant further discussed the supporting pre-clinical data in detail, describing the studies submitted (two MIC studies using a number of organisms, a neutropenic mouse thigh infection model and a repeated dose toxicity study in rats).
Maltese: MIC li użaw għadd ta' organiżmi, mudell ta' infezzjoni tal-koxxa ta' ġurdien newtropeniku u studju ta' tossiċità b' doża ripetuta filfirien).
English: The CHMP considered that similarity with regards to the free drug is important and that with regards to free AUC, the sum of all free TA2 subcomponents is 13% higher for Teicoplanin Hospira.
Maltese: Is-CHMP ikkunsidra li xebħ fir-rigward tal-mediċina libera huwa importanti u li f'dak li jirrigwarda l-AUC libera, it-total tas-subkomponenti TA2 liberi kollha huwa 13% ogħla għal Teicoplanin Hospira.
English: The Applicant discussed the results of a post hoc analysis on the free AUC, rather than on total AUC.
Maltese: L-Applikant iddiskuta r-riżultati ta' analiżi post hoc dwar l-AUC libera, minflok dwar l-AUC totali.
English: Question 5- The post hoc analysis conducted by the Applicant as a response to the concerned member state Day 145 comments was based on the individual Cmax/MIC or AUC/MIC ratios, determined for each subcomponent and then summed.
Maltese: Mistoqsija 5 - L-analiżi post hoc li saret mill-Applikant bħala tweġiba għall-kummenti tal-Jum 145 tal-Istat Membru kkonċernat kienet ibbażata fuq is-Cmax/MIC individwali jew il-proporzjonijiet AUC/MIC, iddeterminati għal kull subkomponent u mbagħad totalizzati.
English: Comparable free AUC/MIC activity cannot waive potential PK differences or the outcome of the bioequivalence study.
Maltese: Attività AUC/MIC libera komparabbli ma tistax tiċħad differenzi PK potenzjali jew l-eżitu tal-istudju dwar il-bijoekwivalenza.
English: Teicoplanin Hospira has a different sub-component mix to the originator; however the Applicant considers that it is not reasonable to use total teicoplanin MICs to assess the impact of differing proportions of subcomponents.
Maltese: Teicoplanin Hospira għandu taħlita ta' subkomponenti differenti mill-oriġinatur; madankollu l-Applikant jikkunsidra li mhuwiex raġonevoli li jintużaw MICs ta' teicoplanin totali biex jiġi evalwat l-impatt ta' proporzjonijiet differenti ta' subkomponenti.
English: The CHMP therefore adopted the following List of Outstanding Issues to be addressed by the Applicant: “Following discussion and considering the differences in the composition and the demonstrated PK differences, the CHMP was of the opinion that it was not sufficiently demonstrated that Teicoplanin Hospira is a generic of Targocid.
Maltese: Għalhekk, is-CHMP adotta l-Lista li ġejja ta' Kwistjonijiet Pendenti li għandhom ikunu indirizzati mill-Applikant: “Wara diskussjoni u meta wieħed jikkunsidra d-differenzi fil-kompożizzjoni u ddifferenzi PK li ntwerew, is-CHMP kien tal-opinjoni li ma ntweriex b'mod suffiċjenti li Teicoplanin Hospira huwa ġeneriku ta' Targocid.
English: The CHMP adopted a list of questions to be addressed by the Applicant.
Maltese: Is-CHMP adotta lista ta' mistoqsijiet li għandhom ikunu indirizzati mill-Applikant.
English: Protein binding was assessed, showing that the unbound fraction for each sub-component was essentially similar for Targocid and Teicoplanin Hospira and confirming that the individual protein binding values for the subcomponents did not vary with the different component composition.
Maltese: L-irbit talproteini ġie evalwat, u wera li l-frazzjoni mhux marbuta għal kull subkomponent kienet essenzjalment simili għal Targocid u Teicoplanin Hospira u kkonferma li l-valuri individwali ta' rbit tal-proteini għassubkomponenti ma nbidlux mal-kompożizzjoni differenti tal-komponenti.
English: Question 6 - The MIC values used in the calculations for each sub-component have not been approved by the EUCAST.
Maltese: Mistoqsija 6 - Il-valuri MIC użati fil-kalkoli għal kull subkomponent ma ġewx approvati mill-EUCAST.
English: The Applicant also provided a briefing document stating that other endpoints, including pharmacodynamics, protein binding and analysis of the PK and PD of the principal sub-components, were measured in the study as it is believed that only free drug (non-protein bound teicoplanin) contributes to pharmacodynamic activity.
Maltese: L-Applikant ipprovda wkoll dokument qasir li jiddikjara li endpoints oħrajn, inkluż il-farmakodinamika, l-irbit tal-proteini u lanaliżi tal-PK u l-PD tas-subkomponenti prinċipali, tkejlu fl-istudju minħabba li huwa mifhum li mediċina libera biss (teicoplanin mhux marbut mal-proteini) jikkontribwixxi għal attività farmakodinamika.
English: The Applicant conducted a bioequivalence study to provide further information on the PK/PD and to demonstrate similar safety and efficacy.
Maltese: L-Applikant għamel studju ta' bijoekwivalenza sabiex jipprovdi aktar tagħrif dwar il-PK/PD u biex juri sigurtà u effikaċja simili.
English: - the submitted additional non-clinical and serum bactericidal data are not sufficient to adequately demonstrate that Teicoplanin Hospira is a generic of Targocid the CHMP has recommended the refusal of the granting of the Marketing Authorisations for Teicoplanin Hospira and associated names (see Annex I).
Maltese: - Id-dejta addizzjonali mhux klinika u d-dejta batteriċida fis-serum sottomessa mhijiex biżżejjed biex turi b'mod adegwat li Teicoplanin Hospira huwa ġeneriku ta' Targocid is-CHMP irrakkomanda r-rifjut tal-għoti ta' Awtorizzazzjonijiet għat-Tqegħid fis-Suq għal Teicoplanin Hospira u ismijiet assoċjati (ara Anness I).
English: The Applicant stated that the antimicrobial potency of the drug is a sum of the component parts and that In vitro antibacterial potency is established by MIC testing.
Maltese: L-Applikant iddikjara li l-qawwa antimikrobjali tal-mediċina hija total tal-partijiet komponenti u li l-qawwa antibatterika In vitro hija stabbilita permezz ta' ttestjar MIC.
English: The issue was considered unresolved and needs further discussion.
Maltese: Il-kwistjoni tqieset mhux solvuta u li teħtieġ aktar diskussjoni.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF TEICOPLANIN HOSPIRA AND ASSOCIATED NAMES (SEE ANNEX I)
Maltese: TAL-EVALWAZZJONI XJENTIFIKA TA' TEICOPLANIN HOSPIRA U ISMIJIET ASSOĊJATI (ARA ANNESS I)
English: The effect of variability in PK on the expected outcome (AUC/MIC) was assessed and even with differences in distributions for the subcomponents, the overall AUC/MIC values are similar for the two products.
Maltese: L-effett tal-varjabbiltà fil-PK fuq l-eżitu mistenni (AUC/MIC) ġie evalwat u anki b'differenzi fid-distribuzzjonijiet għas-subkomponenti, il-valuri AUC/MIC globali huma simili għażżewġ prodotti.
English: The Applicant discussed the compliance of Teicoplanin Hospira to the monographs, stating that the tighter controls over the individual components proposed signify that the active pharmaceutical ingredient used in Teicoplanin Hospira meets the requirements of both monographs and that the individual components are controlled to a far greater extent.
Maltese: L-Applikant iddiskuta l-konformità ta' Teicoplanin Hospira mal-monografi, u ddikjara li l-kontrolli aktar stretti fuq il-komponenti individwali proposti jfissru li l-ingredjent farmaċewtiku attiv użat f'Teicoplanin Hospira jissodisfa rrekwiżiti taż-żewġ monografi u li l-komponenti individwali huma kkontrollati b'mod ferm akbar.
English: Question 3 - The Applicant should discuss the scientific basis for the post hoc analysis on the free AUC instead of the total AUC.
Maltese: Mistoqsija 3 - L-Applikant għandu jiddiskuti l-bażi xjentifika għall-analiżi post hoc dwar l-AUC libera minflok l-AUC totali.
English: The Applicant concluded that taking into account the teicoplanin subcomponents and their relative amounts, lipophilicity and MIC's, numerous experts believe that in a clinical setting, teicoplanin should be treated as a whole, regardless of the relative levels of subcomponents, due to the differences in PK characteristics being small.
Maltese: L-Applikant ikkonkluda li meta wieħed jikkunsidra s-subkomponenti ta' teicoplanin u l-ammonti relattivi tagħhom, il-lipofiliċità u l-MIC's, bosta esperti jemmnu li fi sfond kliniku, teicoplanin għandu jkun ittrattat bħala sħiħ, irrispettivament millivelli relattivi ta' subkomponenti, minħabba li d-differenzi fil-karatteristiċi PK huma żgħar.
English: It was however noted that tissue concentrations of drug components were not measured and that regarding the toxicology, it cannot be concluded whether the products are comparable as the histopathology was investigated only for Teicoplanin Hospira.
Maltese: Madankollu ġie nnutat li konċentrazzjonijiet fit-tessut tal-komponenti tal-mediċina ma tkejlux u li rigward it-tossikoloġija, ma jistax jiġi konkluż jekk il-prodotti humiex komparabbli minħabba li l-istopatoloġija ġiet investigata biss għal Teicoplanin Hospira.
English: The Applicant considers it relevant to measure free drug AUC (as the sum of the major active drug components).
Maltese: LApplikant jikkunsidra rilevanti li jkejjel l-AUC libera tal-mediċina (bħala t-total tal-komponenti ewlenin attivi tal-mediċina).
English: From a GCP perspective and in terms of the data generated which support the CMC and non-clinical data, TEC062 cannot be considered a failed study.
Maltese: Minn perspettiva ta' GCP u fit-termini tad-dejta ġġenerata li tappoġġa s-CMC u d-dejta mhux klinika, TEC062 ma jistax jitqies bħala studju li falla.
English: In conclusion, the CHMP noted that although complying with the European Pharmacopoeia monograph, the quality of Teicoplanin Hospira is different from the innovator subcomponents as Teicoplanin Hospira does not meet the originator specifications with respect to the individual glycopeptides subcomponents.
Maltese: Fl-aħħar nett, is-CHMP innota li għalkemm tikkonforma mal-monografu tal-Farmakopea Ewropea, ilkwalità ta' Teicoplanin Hospira hija differenti mis-subkomponenti tal-innovatur minħabba li Teicoplanin Hospira ma jissodisfax l-ispeċifikazzjonijiet tal-oriġinatur fir-rigward tas-subkomponenti glikopeptidi individwali.
English: It was considered that Teicoplanin Hospira and Targocid are comparable in terms of overall active drug content, but differ in the composition of the TA-2 subcomponents, resulting in major objections.
Maltese: Ġie kkunsidrat li Teicoplanin Hospira u Targocid huma komparabbli fir-rigward tal-kontenut attiv globali talmediċina, iżda huma differenti fil-kompożizzjoni tas-subkomponenti TA-2, u dan irriżulta f'oġġezzjonijiet kbar.
English: Results from animal studies do not supersede comparative PK data from a clinical study in the evaluation of abridged products.
Maltese: Ir-riżultati mill-istudji fuq l-annimali ma jissuperawx dejta PK komparattiva minn studju kliniku fl-evalwazzjoni ta' prodotti mqassra.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
Maltese: TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, L-APPLIKANTI
English: The nature of the active substance and the fermentation process used may lead to subcomponent differences, affecting the lipophilicity of the drug and as such the PK and indeed, the PK data indicates that for AUC, bioequivalence could not be shown.
Maltese: In-natura tas-sustanza attiva u l-proċess ta' fermentazzjoni wżat jistgħu jwasslu għal differenzi fis-subkomponenti, li jaffettwaw il-lipofiliċità tal-mediċina u bħala tali l-PK u fil-fatt, id-dejta PK tindika li għall-AUC, ma setgħetx tintwera bijoekwivalenza.
English: However, the validity and sensitivity of free AUC and PK/PD parameters in the evaluation of a generic product have not been established, and this approach contravenes the CHMP guideline on the Investigation of Bioavailability and Bioequivalence.
Maltese: Madankollu, il-validità u s-sensittività ta' AUC libera u l-parametri PK/PD fl-evalwazzjoni ta' prodott ġeneriku ma ġewx stabbiliti, u dan l-approċċ jikser il-linja gwida tas-CHMP dwar l-Investigazzjoni tal-Bijodisponibbiltà u talBijoekwivalenza.
English: The Applicant should provide an analysis based on whole (total) teicoplanin plasma concentrations.
Maltese: L-Applikant għandu jipprovdi analiżi bbażata fuq il-konċentrazzjonijiet sħaħ (totali) ta' teicoplanin fil-plażma.
English: Finally, the in vitro MIC studies performed by the Applicant are not sensitive enough to detect any differences between the two products since in vitro anti-bacterial activity is independent of lipophilicity, tissue distribution and clearance of the subcomponents.
Maltese: MIC in vitro li saru mill-Applikant mhumiex sensittivi biżżejjed biex isibu differenzi bejn iż-żewġ prodotti minħabba li l-attività antibatterika in vitro mhijiex dipendenti mil-lipofiliċità, mid-distribuzzjoni tat-tessut u mit-tneħħija tas-subkomponenti.
English: In addition, the use of MIC values from 1984 published data is not supported and correlating PK/PD with clinical outcome and the probability of achieving certain targets is not accepted for abridged products.
Maltese: Barra minn hekk, l-użu ta' valuri MIC minn dejta ppubblikata fl-1984 mhuwiex appoġġjat u l-korrelazzjoni tal-PK/PD mal-eżitu kliniku u l-probabbiltà li jinkisbu ċerti miri mhijiex aċċettata għal prodotti mqassra.