Clinical pharmacology as a cornerstone of orphan drug development

被引：23

作者：

Bashaw, Edward D. ^{[1
]}

Huang, Shiew-Mei ^{[1
]}

Cote, Timothy R. ^{[2
,3
]}

Pariser, Anne R. ^{[4
]}

Garnett, Christine E. ^{[1
]}

Burckart, Gilbert ^{[1
]}

Zhang, Lei ^{[1
]}

Men, Angela Y. ^{[1
]}

Le, Christine D. ^{[1
]}

Charlab, Rosane ^{[1
]}

Gobburu, Jogaro V. ^{[1
]}

Lesko, Lawrence J. ^{[5
]}

机构：

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

[2] Natl Org Rare Disorders, Washington, DC 20008 USA

[3] Keck Grad Inst, Claremont, CA 91711 USA

[4] US FDA, Off New Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

[5] Univ Florida, Coll Pharm, Gainesville, FL 32610 USA

来源：

NATURE REVIEWS DRUG DISCOVERY | 2011年 / 10卷 / 11期

关键词：

D O I：

10.1038/nrd3595

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

A recent US Food and Drug Administration (FDA) advisory committee meeting highlighted the potential of clinical pharmacology to overcome challenges in orphan drug development. © 2011 Macmillan Publishers Limited. All rights reserved.

引用

页码：795 / 796

页数：2

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