Bioequivalence: The regulatory career of a pharmaceutical concept

Daniel Carpenter, Dominique A Tobbell

Research output: Contribution to journalArticle

27 Citations (Scopus)

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

Fingerprint

Therapeutic Equivalency
Generic Drugs
Pharmaceutical Preparations
Lawyers
Administrative Personnel
Joints
History
Food
Drugs
Pharmaceuticals

Keywords

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

Cite this

Bioequivalence : The regulatory career of a pharmaceutical concept. / Carpenter, Daniel; Tobbell, Dominique A.

In: Bulletin of the History of Medicine, Vol. 85, No. 1, 16.08.2011, p. 93-131.

Research output: Contribution to journalArticle

@article{8c63d21b961a43d4b612ecbd41d0f1e0,
title = "Bioequivalence: The regulatory career of a pharmaceutical concept",
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.",
keywords = "Bioequivalence, Drug regulation, Food and drug administration, Generic drugs, Regulatory science",
author = "Daniel Carpenter and Tobbell, {Dominique A}",
year = "2011",
month = "8",
day = "16",
language = "English (US)",
volume = "85",
pages = "93--131",
journal = "Bulletin of the History of Medicine",
issn = "0007-5140",
publisher = "Johns Hopkins University Press",
number = "1",

}

TY - JOUR

T1 - Bioequivalence

T2 - The regulatory career of a pharmaceutical concept

AU - Carpenter, Daniel

AU - Tobbell, Dominique A

PY - 2011/8/16

Y1 - 2011/8/16

N2 - 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.

AB - 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.

KW - Bioequivalence

KW - Drug regulation

KW - Food and drug administration

KW - Generic drugs

KW - Regulatory science

UR - http://www.scopus.com/inward/record.url?scp=79957869637&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79957869637&partnerID=8YFLogxK

M3 - Article

C2 - 21551918

AN - SCOPUS:79957869637

VL - 85

SP - 93

EP - 131

JO - Bulletin of the History of Medicine

JF - Bulletin of the History of Medicine

SN - 0007-5140

IS - 1

ER -