Preventive vaccines against bioterrorism: evaluation of efficacy and safety

被引：4
|
作者：
Horne, AD
Clifford, J
Goldenthal, KL
Kleppinger, C
Lachenbruch, PA
机构：
[1] US FDA, Div Biostat, Off Biostat & Epidemiol, CBER, Rockville, MD 20852 USA
[2] US FDA, Div Vaccines & Related Prod Applicat, Off Vaccine Res & Review, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA
[3] NIDA, Ctr Clin Trials Network, NIH, Bethesda, MD 20892 USA
来源：
VACCINE | 2004年 / 23卷 / 01期
关键词：
immunogenicity; non-inferiority; Animal Rule;
D O I：
10.1016/j.vaccine.2004.04.037
中图分类号：
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号：
100102 ;
摘要：
This paper discusses the US Food and Drug Administration's approach to evaluation of vaccines in general, and vaccines against diseases of bioterrorism in particular. We summarize the scientific bases for development and approval of vaccines and then discuss specific issues regarding vaccines against disease organisms that could potentially be used as weapons of bioterrorism. Published by Elsevier Ltd.
引用
收藏
页码：84 / 90
页数：7
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