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Individual bioequivalence - A review of the FDA draft guidance

Publication ,  Journal Article
Chow, SC
Published in: Drug Information Journal
1999

As more generic drugs become available in the marketplace, it is a public concern whether the quality, safety, and efficacy of generic drugs are the same as the brand name drug. Under current regulation, the United States Food and Drug Administration (FDA) only requires that evidence of bioequivalence in average bioavailability be provided for assessment of bioequivalence. FDA, however, does not require that bioequivalence among generic copies of the same brand name drug be demonstrated. As a result, it is a concern whether these generic drugs can be used interchangeably. To address this question, the concepts of population bioequivalence for drug prescribability and individual bioequivalence for drug switchability have been proposed. In this paper, we provide a comprehensive review of the draft FDA guidance on 'In Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Approaches' which was distributed for comment in October 1997. The discussion will be primarily on the FDA proposed criteria, design, statistical methods, and interpretations on the assessment of individual bioequivalence from the pharmaceutical industry perspective.

Duke Scholars

Published In

Drug Information Journal

ISSN

0092-8615

Publication Date

1999

Volume

33

Issue

2

Start / End Page

435 / 444

Related Subject Headings

  • Statistics & Probability
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1117 Public Health and Health Services
  • 0104 Statistics
 

Citation

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ICMJE
MLA
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Chow, S. C. (1999). Individual bioequivalence - A review of the FDA draft guidance. Drug Information Journal, 33(2), 435–444.
Chow, S. C. “Individual bioequivalence - A review of the FDA draft guidance.” Drug Information Journal 33, no. 2 (1999): 435–44.
Chow SC. Individual bioequivalence - A review of the FDA draft guidance. Drug Information Journal. 1999;33(2):435–44.
Chow, S. C. “Individual bioequivalence - A review of the FDA draft guidance.” Drug Information Journal, vol. 33, no. 2, 1999, pp. 435–44.
Chow SC. Individual bioequivalence - A review of the FDA draft guidance. Drug Information Journal. 1999;33(2):435–444.

Published In

Drug Information Journal

ISSN

0092-8615

Publication Date

1999

Volume

33

Issue

2

Start / End Page

435 / 444

Related Subject Headings

  • Statistics & Probability
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1117 Public Health and Health Services
  • 0104 Statistics