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Clin Pharmacol Ther. 2010 Nov;88(5):587-9.
The role of clinical pharmacology in supporting the emergency use authorization of an unapproved anti-influenza drug, peramivir.
Arya V, Carter WW, Robertson SM.
Division of Clinical Pharmacology 4, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Abstract
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.
PMID: 20959843 [PubMed - in process]
The role of clinical pharmacology in supporting the emergency use authorization of an unapproved anti-influenza drug, peramivir.
Arya V, Carter WW, Robertson SM.
Division of Clinical Pharmacology 4, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Abstract
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.
PMID: 20959843 [PubMed - in process]
