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Meta-analysis for bioequivalence review.

Publication ,  Journal Article
Chow, SC; Liu, J
Published in: J Biopharm Stat
March 1997

The problem of drug interchangeability among a brand-name drug and its generic copies is considered. Under current Food and Drug Administration (FDA) regulation, a patient may switch from the brand-name drug to a generic drug if the generic drug is shown to be bioequivalent to the brand-name drug based on bioequivalence testing. After the patent of a brand-name drug is expired, usually there will be a number of generic copies available on the market. The FDA does not indicate that a patient may switch from a generic to another even though both of the generic drugs are bioequivalent to the brand-name drug. As a result, drug interchangeability among the brand-name and its generic copies is a safety concern. In this paper, we propose to perform a meta-analysis for an overview of bioequivalence. The proposed meta-analysis provides an assessment of bioequivalence among generic copies of a brand-name that can be used as a tool to monitor the performance of the approved generic copies of the brand-name drug. In addition, it provides more accurate estimates of inter- and intrasubject variabilities of the drug product.

Duke Scholars

Published In

J Biopharm Stat

DOI

ISSN

1054-3406

Publication Date

March 1997

Volume

7

Issue

1

Start / End Page

97 / 111

Location

England

Related Subject Headings

  • Therapeutic Equivalency
  • Statistics as Topic
  • Statistics & Probability
  • Models, Biological
  • Meta-Analysis as Topic
  • Mathematical Computing
  • Individuality
  • Humans
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
 

Citation

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Chow, S. C., & Liu, J. (1997). Meta-analysis for bioequivalence review. J Biopharm Stat, 7(1), 97–111. https://doi.org/10.1080/10543409708835172
Chow, S. C., and J. Liu. “Meta-analysis for bioequivalence review.J Biopharm Stat 7, no. 1 (March 1997): 97–111. https://doi.org/10.1080/10543409708835172.
Chow SC, Liu J. Meta-analysis for bioequivalence review. J Biopharm Stat. 1997 Mar;7(1):97–111.
Chow, S. C., and J. Liu. “Meta-analysis for bioequivalence review.J Biopharm Stat, vol. 7, no. 1, Mar. 1997, pp. 97–111. Pubmed, doi:10.1080/10543409708835172.
Chow SC, Liu J. Meta-analysis for bioequivalence review. J Biopharm Stat. 1997 Mar;7(1):97–111.
Journal cover image

Published In

J Biopharm Stat

DOI

ISSN

1054-3406

Publication Date

March 1997

Volume

7

Issue

1

Start / End Page

97 / 111

Location

England

Related Subject Headings

  • Therapeutic Equivalency
  • Statistics as Topic
  • Statistics & Probability
  • Models, Biological
  • Meta-Analysis as Topic
  • Mathematical Computing
  • Individuality
  • Humans
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences