The analysis of bioequivalence with respect to tmax under a 2 x 2 crossover design

Thomas R. Ten Have, Vernon M. Chinchilli

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

We develop population-averaged and subject-specific continuation ratio logit models for assessing bioequivalence of two formulations with respect to TMAX under a 2 x 2 crossover design. We propose generalized estimating equations and mixed-effects estimators for obtaining confidence intervals for odds ratios representing population-averaged and subject-specific formulation effects. We show analytically that the population-averaged approach leads to asymptotic intervals that are narrower than the subject-specific intervals when the intrasubject correlation is positive. Hence, asymptotically, it is easier to show bioequivalence with respect to TMAX under the pop-ulation-averaged approach than under the subject-specific approach. We illustrate these results with an analysis of a multiple-dose bio-equivalence study.

Original languageEnglish (US)
Pages (from-to)185-199
Number of pages15
JournalJournal of Biopharmaceutical Statistics
Volume5
Issue number2
DOIs
StatePublished - Jan 1 1995

All Science Journal Classification (ASJC) codes

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

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