tetano
Editor, Senior Moderator
Clin Pharmacol Ther. 2011 Feb;89(2):172-4.
The Emergency Use Authorization of Peramivir IV: A View from the Manufacturer.
Hollister AS, Sheridan WP.
Clinical Pharmacology, BioCryst Pharmaceuticals, Inc., Durham, North Carolina, USA.
Abstract
The 2009 H1N1 influenza pandemic prompted the US Food and Drug Administration (FDA) to issue an emergency use authorization (EUA) for the intravenous antiviral peramivir, an unapproved neuraminidase inhibitor (NAI) currently under development. Peramivir use was limited to patients for whom other NAI therapy had failed or in whom oral or inhalational drug absorption was believed to be unreliable. This introduced a patient selection bias that precluded safety and efficacy assessment. Despite the challenges and risks, there was a compelling public health need for an intravenous agent during the 2009 H1N1 pandemic.
PMID: 21252934 [PubMed - in process]
http://www.ncbi.nlm.nih.gov/pubmed/21252934
The Emergency Use Authorization of Peramivir IV: A View from the Manufacturer.
Hollister AS, Sheridan WP.
Clinical Pharmacology, BioCryst Pharmaceuticals, Inc., Durham, North Carolina, USA.
Abstract
The 2009 H1N1 influenza pandemic prompted the US Food and Drug Administration (FDA) to issue an emergency use authorization (EUA) for the intravenous antiviral peramivir, an unapproved neuraminidase inhibitor (NAI) currently under development. Peramivir use was limited to patients for whom other NAI therapy had failed or in whom oral or inhalational drug absorption was believed to be unreliable. This introduced a patient selection bias that precluded safety and efficacy assessment. Despite the challenges and risks, there was a compelling public health need for an intravenous agent during the 2009 H1N1 pandemic.
PMID: 21252934 [PubMed - in process]
http://www.ncbi.nlm.nih.gov/pubmed/21252934