Bioequivalence: The Regulatory Career of a Pharmaceutical Concept
Bioequivalence: The Regulatory Career of a Pharmaceutical Concept
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DOI：
10.1353/bhm.2011.0024
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发表时间：
2011-03-01
影响因子：
1
通讯作者：
Tobbell, Dominique A.
中科院分区：
文献类型：
--
作者：
Carpenter, Daniel;Tobbell, Dominique A.
非专利药不能：没有法规和临床证明的“生物等效性”上市。作者认为，“生物等效性”的概念是监管和科学的共同创造，而不是纯粹的技术概念，也不是纯粹的法律的概念。它是在药理学家、监管机构、食品和药品律师以及对“仿制”药感兴趣的美国和欧洲政策制定者网络的间隙发展起来的。本文提供了一个生物等效性的历史，它强调了国家的科学过程中，监管机构和科学家的网络，以及跨国动态的中心地位，在药物监管标准的形成的塑造作用。
Generic drugs cannot: be marketed without regulatory and clinical demonstration of "bioequivalence." The authors argue that the concept of "bioequivalence" is a joint regulatory and scientific creation, not purely a technical concept, and not purely a legal concept. It developed at the interstices of networks of pharmacologists, regulators, food and drug lawyers, and American and European policy makers interested in "generic" drugs. This article provides a situated perspective on the history of bioequivalence, which emphasizes the shaping role of the state upon scientific processes, networks of regulators and scientists, and the centrality of transnational dynamics in the formation of drug regulatory standards.