公开(公告)号：EP3879534A1

公开(公告)日：2021-09-15

申请号：EP21170633.8

申请日：2014-06-20

申请人： Takeda Pharmaceutical Company Limited

发明人： Loew-Baselli, Alexandra ,  Spotts, Gerald Dickey ,  Oh, MyungShin

IPC分类号： G16B5/20 ,  G16C20/30 ,  A61P7/04

摘要： A system and method for providing a therapeutic plasma protein dosing regime includes determining a pharmacokinetic profile of a patient using a Bayesian model of pharmacokinetic profiles of sampled patients. The example system and method also include determining a first dosing regime for a first specified dosing interval including (i) a first dosage and (ii) a first therapeutic plasma protein level in the patient over a time period based at least upon the pharmacokinetic profile and determining a second dosing regime for a second specified dosing interval including (i) a second dosage and (ii) a second therapeutic plasma protein level in the patient over the time period based at least upon the pharmacokinetic profile. The example system and method further include displaying the first dosing regime and the second dosing regime on a client device such that the first dosing regime is displayed in conjunction with the second dosing regime.

公开(公告)号：EP4343774A3

公开(公告)日：2024-06-05

申请号：EP23214198.6

申请日：2017-04-13

申请人： Takeda Pharmaceutical Company Limited

发明人： Kuchimanchi, Kameswara Rao ,  Loew-Baselli, Alexandra ,  Spotts, Gerald ,  Oh, MyungShin ,  Hale, Michael Don ,  Wolfsegger, Martin

IPC分类号： A61P7/04 ,  G06N7/00 ,  G16H20/17 ,  G16H20/30 ,  G16C20/30 ,  G16H50/50

CPC分类号： G16C20/30 ,  G16C20/70 ,  A61P7/04 ,  G16H20/17 ,  G06N7/01 ,  G16H50/50

摘要： Systems and methods for providing a clotting factor VIII (CFVIII) dosing regimen include collecting two blood samples from a patient after an infusion of CFVIII and determining a CFVIII clearance based on the two blood samples, and determining if a patient has a half-life greater than a predetermined threshold. A pharmacokinetic (PK) profile of the patient is determined using a Bayesian model of pharmacokinetic profiles of sampled patients having similar body weight or age of the patient. A first weight is applied to the Bayesian model of pharmacokinetic profiles of sampled patients if the half-life of the patient is greater than the predetermined threshold, and a second weight, less than the first weight, is applied to the Bayesian model of pharmacokinetic 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.

公开(公告)号：EP4343774A2

公开(公告)日：2024-03-27

申请号：EP23214198.6

申请日：2017-04-13

申请人： Takeda Pharmaceutical Company Limited

发明人： Kuchimanchi, Kameswara Rao ,  Loew-Baselli, Alexandra ,  Spotts, Gerald ,  Oh, MyungShin ,  Hale, Michael Don ,  Wolfsegger, Martin

IPC分类号： G16C20/30

摘要： Systems and methods for providing a clotting factor VIII (CFVIII) dosing regimen include collecting two blood samples from a patient after an infusion of CFVIII and determining a CFVIII clearance based on the two blood samples, and determining if a patient has a half-life greater than a predetermined threshold. A pharmacokinetic (PK) profile of the patient is determined using a Bayesian model of pharmacokinetic profiles of sampled patients having similar body weight or age of the patient. A first weight is applied to the Bayesian model of pharmacokinetic profiles of sampled patients if the half-life of the patient is greater than the predetermined threshold, and a second weight, less than the first weight, is applied to the Bayesian model of pharmacokinetic 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.