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Bioavailability and bioequivalence in drug development

Publication ,  Journal Article
Chow, SC
Published in: Wiley Interdisciplinary Reviews: Computational Statistics
January 1, 2014

Bioavailability is referred to as the extent and rate to which the active drug ingredient or active moiety from the drug product is absorbed and becomes available at the site of drug action. The relative bioavailability in terms of the rate and extent of drug absorption is considered predictive of clinical outcomes. In 1984, the United States Food and Drug Administration (FDA) was authorized to approve generic drug products under the Drug Price Competition and Patent Term Restoration Act based on evidence of average bioequivalence in drug absorption through the conduct of bioavailability and bioequivalence studies. This article provides an overview (from an American point of view) of definition of bioavailability and bioequivalence, Fundamental Bioequivalence Assumption, regulatory requirements, and process for bioequivalence assessment of generic drug products. Basic considerations including criteria, study design, power analysis for sample size determination, and the conduct of bioequivalence trial, and statistical methods are provided. Practical issues such as one-size-fits-all criterion, drug interchangeability and scaled average criteria for assessment of highly variable drug products are also discussed. © 2014 Wiley Periodicals, Inc.

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Published In

Wiley Interdisciplinary Reviews: Computational Statistics

DOI

EISSN

1939-0068

ISSN

1939-5108

Publication Date

January 1, 2014

Volume

6

Issue

4

Start / End Page

304 / 312

Related Subject Headings

  • 4905 Statistics
  • 4605 Data management and data science
  • 0802 Computation Theory and Mathematics
  • 0104 Statistics
  • 0102 Applied Mathematics
 

Citation

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Chow, S. C. (2014). Bioavailability and bioequivalence in drug development. Wiley Interdisciplinary Reviews: Computational Statistics, 6(4), 304–312. https://doi.org/10.1002/wics.1310
Chow, S. C. “Bioavailability and bioequivalence in drug development.” Wiley Interdisciplinary Reviews: Computational Statistics 6, no. 4 (January 1, 2014): 304–12. https://doi.org/10.1002/wics.1310.
Chow SC. Bioavailability and bioequivalence in drug development. Wiley Interdisciplinary Reviews: Computational Statistics. 2014 Jan 1;6(4):304–12.
Chow, S. C. “Bioavailability and bioequivalence in drug development.” Wiley Interdisciplinary Reviews: Computational Statistics, vol. 6, no. 4, Jan. 2014, pp. 304–12. Scopus, doi:10.1002/wics.1310.
Chow SC. Bioavailability and bioequivalence in drug development. Wiley Interdisciplinary Reviews: Computational Statistics. 2014 Jan 1;6(4):304–312.
Journal cover image

Published In

Wiley Interdisciplinary Reviews: Computational Statistics

DOI

EISSN

1939-0068

ISSN

1939-5108

Publication Date

January 1, 2014

Volume

6

Issue

4

Start / End Page

304 / 312

Related Subject Headings

  • 4905 Statistics
  • 4605 Data management and data science
  • 0802 Computation Theory and Mathematics
  • 0104 Statistics
  • 0102 Applied Mathematics