On the assessment of variability in bioavailability/bioequivalence studies


Journal Article

A procedure is proposed for the assessment of bioequivalence of variabilities between two formulations in bioavailability/bioequivalence studies. This procedure is essentially a two one-sided Pitman-Morgan's tests procedure which is based on the correlation between crossover differences and subject totals. The nonparametric version of the proposed test is also discussed. A dataset of AUC from a 2x2 crossover bioequivalence trial is presented to illustrate the proposed procedures. © 1992, Taylor & Francis Group, LLC. All rights reserved.

Full Text

Duke Authors

Cited Authors

  • Liu, JP; Chow, SC

Published Date

  • January 1, 1992

Published In

Volume / Issue

  • 21 / 9

Start / End Page

  • 2591 - 2607

Electronic International Standard Serial Number (EISSN)

  • 1532-415X

International Standard Serial Number (ISSN)

  • 0361-0926

Digital Object Identifier (DOI)

  • 10.1080/03610929208830932

Citation Source

  • Scopus