“Bioequivalence: The Regulatory Career of a Pharmaceutical Concept”

Citation:

Carpenter D, Tobbell D. “Bioequivalence: The Regulatory Career of a Pharmaceutical Concept”. Bulletin of the History of Medicine [Internet]. 2011;85 (1) :93-131.

Abstract:

Generic drugs cannot be marketed without regulatory and clini- cal demonstration of “bioequivalence.” The authors argue that the concept of “bioequivalence” is a joint regulatory and scientific creation, not purely a tech- nical 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.

Publisher's Version

Last updated on 01/22/2020