- 专利标题: METHOD AND APPARATUS FOR PROVIDING A PHARMACOKINETIC DRUG DOSING REGIMENT
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申请号: EP23214198.6申请日: 2017-04-13
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公开(公告)号: EP4343774A3公开(公告)日: 2024-06-05
- 发明人: Kuchimanchi, Kameswara Rao , Loew-Baselli, Alexandra , Spotts, Gerald , Oh, MyungShin , Hale, Michael Don , Wolfsegger, Martin
- 申请人: Takeda Pharmaceutical Company Limited
- 申请人地址: JP Osaka-shi, Osaka 1-1, Doshomachi 4-chome Chuo-ku
- 专利权人: Takeda Pharmaceutical Company Limited
- 当前专利权人: Takeda Pharmaceutical Company Limited
- 当前专利权人地址: JP Osaka-shi, Osaka 1-1, Doshomachi 4-chome Chuo-ku
- 代理机构: Hoffmann Eitle
- 优先权: US 201662323015 P 2016.04.15
- 分案原申请号: 17783092.4 2017.04.13
- 主分类号: A61P7/04
- IPC分类号: A61P7/04 ; G06N7/00 ; G16H20/17 ; G16H20/30 ; G16C20/30 ; 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.
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