Bioequivalence: The regulatory career of a pharmaceutical concept

Daniel Carpenter, Dominique A. Tobbell

Research output: Contribution to journalArticlepeer-review

27 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)93-131
Number of pages39
JournalBulletin of the History of Medicine
Volume85
Issue number1
StatePublished - Aug 16 2011

Keywords

  • Bioequivalence
  • Drug regulation
  • Food and drug administration
  • Generic drugs
  • Regulatory science

Fingerprint Dive into the research topics of 'Bioequivalence: The regulatory career of a pharmaceutical concept'. Together they form a unique fingerprint.

Cite this