期刊
CLINICAL PHARMACOLOGY & THERAPEUTICS
卷 109, 期 4, 页码 971-976出版社
WILEY
DOI: 10.1002/cpt.2201
关键词
-
The FDA's Animal Rule provides a regulatory pathway for treating serious conditions caused by exposure to lethal agents, based on integrating clinical pharmacology evidence to determine effective human doses.
The Food and Drug Administration's (FDA's) Animal Rule provides a unique regulatory pathway for drugs and biologics intended to treat serious or life-threatening conditions caused by exposure to lethal or permanently disabling chemical, biological, radiological, or nuclear agents when human efficacy studies are not ethical and field trials are not feasible. Human dose selection under the Animal Rule is based on integrating the totality of clinical pharmacology evidence collected in in vitro, animal, and human studies. This review discusses the necessary pharmacokinetic and pharmacodynamic information and methods for determining the effective human dose of antimicrobials under the Animal Rule and presents case studies illustrating the utility of a totality of evidence approach for different methods.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据