The Utility of Modeling and Simulation in Drug Development and Regulatory Review

被引：158

作者：

Huang, Shiew-Mei ^{[1
]}

Abernethy, Darrell R. ^{[1
]}

Wang, Yaning ^{[1
]}

Zhao, Ping ^{[1
]}

Zineh, Issam ^{[1
]}

机构：

[1] US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

来源：

JOURNAL OF PHARMACEUTICAL SCIENCES | 2013年 / 102卷 / 09期

关键词：

regulatory science; PBPK; Modeling and simulation; systems pharmacology; pharmacodynamics; drug interactions; dose-response; pharamcokinetics; PHYSIOLOGICALLY-BASED PHARMACOKINETICS; IN-VIVO EXTRAPOLATION; CLINICAL-PHARMACOLOGY; SAFETY ASSESSMENT; TRANSPORTERS; FESOTERODINE; INFORMATICS; PREDICTION; SCIENCE; IMPACT;

D O I：

10.1002/jps.23570

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

US Food and Drug Administration (FDA) has identified innovation in clinical evaluations as a major scientific priority area. This paper provides case studies and updates to describe the efforts by the FDA's Office of Clinical Pharmacology in its development and application of regulatory science, focusing on modeling and simulation. Key issues and challenges are identified that need to be addressed to promote the uptake of modeling and simulation approaches in drug regulation. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.

引用

页码：2912 / 2923

页数：12

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