Statistical considerations in bioequivalence trials


Journal Article

We discuss the statistical issues in evaluation of bioequivalence addressed by the FDA Bioequivalence Hearing (1986) and Guidance on Statistical Procedures for Bioequivalence Studies released by the Division of Bioequivalence, Office of Generic Drugs of FDA (1992). They are logarithmic transformation of pharmacokinetic data, sequence effect, and outlying data. We also compare the additive model with the multiplicative model, examine the relationship between intrasubject variability and interchangeability, describe the concept of population versus individual bioequivalence, and investigate the distributions of AUC and C max . © 1994, Taylor & Francis Group, LLC. All rights reserved.

Full Text

Duke Authors

Cited Authors

  • Chow, SC; Liu, JP

Published Date

  • January 1, 1994

Published In

Volume / Issue

  • 23 / 2

Start / End Page

  • 325 - 339

Electronic International Standard Serial Number (EISSN)

  • 1532-415X

International Standard Serial Number (ISSN)

  • 0361-0926

Digital Object Identifier (DOI)

  • 10.1080/03610929408831258

Citation Source

  • Scopus