The US Food and Drug Administration's Model-Informed Drug Development Paired Meeting Pilot Program: Early Experience and Impact

被引：27

作者：

Madabushi, Rajanikanth ^{[1
]}

Benjamin, Jessica M. ^{[1
]}

Grewal, Renmeet ^{[1
]}

Pacanowski, Michael A. ^{[1
]}

Strauss, David G. ^{[1
]}

Wang, Yaning ^{[1
]}

Zhu, Hao ^{[1
]}

Zineh, Issam ^{[1
]}

机构：

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

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2019年 / 106卷 / 01期

关键词：

D O I：

10.1002/cpt.1457

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Model-informed drug development (MIDD) is a powerful approach to increase efficiency in drug development, impact regulatory outcomes, and improve drug benefit-risk balance. 1,2 A critical factor for the continued growth of MIDD is a regulatory environment with the capacity, expertise, and transparency that increases stakeholder confidence in MIDD approaches. 3 The US Food and Drug Administration (FDA) MIDD Paired Meeting Pilot Program was established to address this need by providing a dedicated avenue for regulatory interaction on MIDD issues.

引用

页码：74 / 78

页数：5

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