Bioequivalence review for drug interchangeability.

Published

Journal Article

To monitor the performance of the approved generic copies of a brand-name drug, we propose some methods in assessing bioequivalence among generic copies and the brand-name drug, and among generic copies themselves, using data from several bioequivalence studies adopting the standard 2 x 2 crossover design without carryover effects. We propose a meta-analysis method that increases statistical power when the between-subject variability is not large. A nonmeta-analysis is also considered. A numerical example of applying both methods is presented for illustration.

Full Text

Duke Authors

Cited Authors

  • Chow, SC; Shao, J

Published Date

  • August 1999

Published In

Volume / Issue

  • 9 / 3

Start / End Page

  • 485 - 497

PubMed ID

  • 10473033

Pubmed Central ID

  • 10473033

International Standard Serial Number (ISSN)

  • 1054-3406

Digital Object Identifier (DOI)

  • 10.1081/BIP-100101189

Language

  • eng

Conference Location

  • England