Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: Impact of FDA pharmacometrics during 2004-2006

被引：52

作者：

Wang, Yaning ^{[1
]}

Bhottaram, A. Venkatesh ^{[1
]}

Jadhav, Pravin R. ^{[1
]}

Lesko, Lawrence J. ^{[1
]}

Madabushi, Rajanikanth ^{[1
]}

Powell, J. Robert ^{[1
]}

Qiu, Wei ^{[1
]}

Sun, He ^{[1
]}

Yim, Dong S. ^{[1
]}

Zheng, Jenny J. ^{[1
]}

Gobburu, Jogarao V. S. ^{[1
]}

机构：

[1] US FDA, Off Clin Pharmacol, Off Translat Sci, CDER, Silver Spring, MD 20993 USA

来源：

JOURNAL OF CLINICAL PHARMACOLOGY | 2008年 / 48卷 / 02期

关键词：

regulatory decisions; EOP2A meeting; modeling; simulation; FDA; drug development; phormacokinetics; pharmacodynamics; pharmacometrics;

D O I：

10.1177/0091270007311111

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The End-of-Phose 2A meetings are proposed to identify opportunities to make innovative medical products available sooner and to increase the quality of drug applications through early meetings between sponsors and the FDA. This article summarizes the overall experience across 11 pilot End-of-Phase 2A meetings since 2004. Four case studies are presented in more detail to demonstrate the various issues and methods encountered at these meetings. Overall, industry and FDA scientists ranked these meetings to be "very helpful" (average score of 4 on a scale of 1 to 5). In almost all the instances the sponsors changed their drug development plans subsequent to these extensive quantitative analyses-based meetings. A draft Guidance is being developed to be issued in 2008, and we hope this initiative will be resourced by then.

引用

页码：146 / 156

页数：11

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