期刊
CLINICAL PHARMACOLOGY & THERAPEUTICS
卷 88, 期 5, 页码 587-589出版社
NATURE PUBLISHING GROUP
DOI: 10.1038/clpt.2010.187
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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.
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