Highlights from the United States Food and Drug Administration's Public Workshop on the Development of Animal Models of Pregnancy to Address Medical Countermeasures in an "At-Risk" Population of Pregnant Women: Influenza as a Case Study

被引:4
|
作者
Williams, Denita [1 ,2 ]
Basavarajappay, Mallikarjuna S. [1 ]
Rasmussen, Sonja A. [3 ]
Morris, Suzanne [4 ]
Mattison, Donald [5 ,6 ]
机构
[1] US FDA, Div Biochem Toxicol, Natl Ctr Toxicol Res, Jefferson, AR USA
[2] Huntingdon Life Sci Inc, Somerset, NJ USA
[3] US Ctr Dis Control & Prevent, Atlanta, GA USA
[4] US FDA, Div Genet & Mol Toxicol, Natl Ctr Toxicol Res, Jefferson, AR USA
[5] Risk Sci Int, Ottawa, ON, Canada
[6] Univ Ottawa, Ottawa, ON, Canada
关键词
animal models; influenza; oseltamivir phosphate; oseltamivir carboxylate; medical countermeasures; pregnancy; PHARMACOKINETICS; OSELTAMIVIR;
D O I
10.1002/bdra.23319
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
The U.S. Food and Drug Administration (FDA) and other federal agencies partner to ensure that medical countermeasures (e. g., drug therapies and vaccines) are available for public health emergencies (FDA, 2014). Despite continuing progress, providing medical countermeasures and treatment guidelines for certain populations (e. g., pregnant women) is challenging due to the lack of clinical and/or animal data. Thus, a workshop was convened to discuss animal models of pregnancy for the evaluation of disease progression and medical countermeasures. (C) 2014 Wiley Periodicals, Inc.
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页码:806 / 810
页数:5
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