The Role of Clinical Pharmacology in Supporting the Emergency Use Authorization of an Unapproved Anti-Influenza Drug, Peramivir

被引：22

作者：

Arya, V. ^{[1
]}

Carter, W. W. ^{[2
]}

Robertson, S. M. ^{[1
]}

机构：

[1] US FDA, Div Clin Pharmacol 4, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[2] US FDA, Div Antiviral Prod, Off Antimicrobial Prod, Ctr Drug Evaluat & Res, Silver Spring, MD USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2010年 / 88卷 / 05期

关键词：

D O I：

10.1038/clpt.2010.187

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

On 23 October 2009, the commissioner of the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for peramivir for intravenous injection, an unapproved neuraminidase inhibitor used for treating certain hospitalized adult and pediatric patients infected with 2009 H1N1 influenza. This was the first EUA of an unapproved drug product. This report summarizes the critical contributions of the clinical pharmacology review team in support of the peramivir EUA.

引用

页码：587 / 589

页数：4