Patent SG-11201808475X-A (SG)
Title: Method and apparatus for providing a pharmacokinetic drug dosing regiment
Inventor: KUCHIMANCHI KAMESWARA
IPC: G06F19/12
Filed: 2017-04-13
Abstract: INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property -, Organization 11111111011110111010101111101011111011101111110111111110111011111111101111011111 International Bureau 0.. .... .. ..... ..or::,„,' (10) International Publication Number (43) International Publication Date WO 2017/180807 Al 19 October 2017(19.10.2017) WIPO I PCT (51) International Patent Classification: (74) Agents: MEYERS, Thomac, C. et al.; Brown Rudnick A61P 7/04 (2006.01) GOON 7/00 (2006.01) LLP, One Financial Center, Boston, MA 02111 (US). GOOF 19/12 (2011.01) (81) Designated States (unless otherwise indicated, for every (21) International Application Number: kind of national protection available): AE, AG, AL, AM, PCT/US2017/027309 AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, (22) International Filing Date: DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, 13 April 2017 (13.04.2017) HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, (25) Filing Language: English KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, (26) Publication Language: English NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, (30) Priority Data: RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, 62/323,015 15 April 2016 (15.04.2016) US TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (71) Applicants: BAXALTA INCORPORATED [US/US]; 1200 Lakeside Drive, Bannockburn, IL 60015 (US). BAX- (84) Designated States (unless otherwise indicated, for every ALTA GMBH [SZ/CH]; Thurgauerstrasse 130, 8152 kind of regional protection available): ARIPO (BW, GH, Glattpark (Opfikon) (CH). GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, (72) Inventors: KUCHIMANCHI, Kameswara, Rao; 10 TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, Freemont Street, Lexington, MA 02421 (US). LOEW- DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, — BASELLI, Alexandra; Veitingergasse 28, 1130 Vienna LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, — (AT). SPOTTS, Gerald; 300 Shire Way, Lexington, MA SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, _ 02421 (US). OH, Myungshin; 1700 Sawtelle Blvd., Suite GW, KM, ML, MR, NE, SN, TD, TG). 221, Los Angeles, CA 90025 (US). HALE, Michael, Don; . Published: 43 Arlingon Street, Winchester, MA 01890 (US). WOLF- — international 21(3)) SEGGER, Martin; Donau-city-strasse 7, 1220 Vienna with search report (Art. (AT). = = = = = = = = = 1-1 IN © C)1: (54) Title: METHOD AND APPARATUS FOR PROVIDING A PHARMACOKINETIC DRUG DOSING REGIMENT 0 *1 : (57) : Systems and methods for providing a clotting factor VIII (CFVIII) dosing regimen include collecting two blood 1-1 ---- samples from a patient after an infusion of CFVIII and determining a CFVIII clearance based on the two blood samples, and determ - fining if a patient has a half-life greater than a predetermined threshold. A pharmacokinetic (PK) profile of the patient is determined 1-1 C using a Bayesian model of pharmacokinetic profiles of sampled patients having similar body weight or age of the patient. A first ei weight is applied to the Bayesian model of pharmacokinetic profiles of sampled patients if the half-life of the patient is greater than O the predetermined threshold, and a second weight, less than the first weight, is applied to the Bayesian model of pharmacokinetic ,-t profiles of sampled patients if the half-life of the patient is less than the predetermined threshold. A dosing regimen is determined for the patient based on the PK profile.