Clinical Pharmacology and Orphan Drugs: An Informational Inventory 2006-2010

被引：11

作者：

Bashaw, E. D. ^{[1
]}

Fang, L. ^{[1
]}

机构：

[1] US FDA, Biol Team, Div Clin Pharmacol 3, Off Clin Pharmacol,Off Translat Sci,Ctr Drug Eval, Silver Spring, MD USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2012年 / 91卷 / 05期

关键词：

D O I：

10.1038/clpt.2012.23

中图分类号：

R9 [药学];

学科分类号：

100702 [药剂学];

摘要：

Clinical pharmacology can have an important impact on the development of orphan drugs, i.e., therapeutic agents for rare diseases. This topic was explored at a US Food and Drug Administration (FDA) Advisory Committee meeting in March 2011.(1) At that meeting, preliminary data were presented regarding the breakdown of the clinical pharmacology content in the approvals for orphan drugs in 2006-2010. These data, along with follow-up observations, are presented here, focusing on the in vivo study content and the relevant populations.

引用

页码：932 / 936

页数：5