Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision-making-A workshop summary.

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作者： Daphney,Jean ^[1] ; Kunal,Naik ^[1] ; Lauren,Milligan ^[1] ; Stephen,Hall ^[2] ; Shiew,Mei Huang ^[1] ; Nina,Isoherranen ^[3] ; Colleen,Kuemmel ^[1] ; Paul,Seo ^[4] ; Million A,Tegenge ^[5] ; Yaning,Wang ^[1] ; Yuching,Yang ^[1] ; Xinyuan,Zhang ^[1] ; Liang,Zhao ^[6] ; Ping,Zhao ^[7] ; Jessica,Benjamin ^[1] ; Kimberly,Bergman ^[1] ; Joseph,Grillo ^[1] ; Rajanikanth,Madabushi ^[1] ; Fang,Wu ^[6] ; Hao,Zhu ^[1] ; Issam,Zineh ^[1]

作者单位： Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. ^[1] Eli Lilly and Company, Indianapolis, Indiana, USA. ^[2] School of Pharmacy, University of Washington, Seattle, Washington, USA. ^[3] Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. ^[4] Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. ^[5] Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. ^[6] Bill & Melinda Gates Foundation, Seattle, Washington, USA. ^[7]

主题词计算机模拟(Computer Simulation);人类(Humans);模型, 生物学(Models, Biological);药代动力学(Pharmacokinetics);药理学, 临床(Pharmacology, Clinical)

DOI 10.1002/psp4.12706

PMID 34536337

发布时间 2022-05-15

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CPT: pharmacometrics & systems pharmacology

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2021年10卷11期

1271-1275页

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Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision-making-A workshop summary.

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Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision-making-A workshop summary.

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