On Assessment of Bioequivalence for Drugs with Negligible Plasma Levels

Journal Article (Journal Article)

In bioavailability studies, bioequivalence between drug products is usually determined based on some pharmacokinetic responses such as area under the blood or plasma concentration‐time curve and maximum concentration. For some drug products, however, we may have negligible plasma levels because their intended routes of administration. In this case, assessment of bioequivalence between drug products of this kind may be established using clinical endpoints such as therapeutic response and time to the onset of a therapeutic response. In this paper, we propose two procedures which modify the method of generalized estimating equations (Liang and Zeger, 1986) and the proportional hazard models for paired failure times to assess bioequivalence between two drug products under the structure of a standard two‐sequence, two‐period crossover design. An example concerning a bioequivalence trial for albuterol metered dose inhaler indicated for acute bronchospasm (Herson, 1991) is used to illustrate the proposed procedures. Copyright © 1993 WILEY‐VCH Verlag GmbH & Co. KGaA

Full Text

Duke Authors

Cited Authors

  • Liu, J; Chow, S

Published Date

  • January 1, 1993

Published In

Volume / Issue

  • 35 / 1

Start / End Page

  • 109 - 123

Electronic International Standard Serial Number (EISSN)

  • 1521-4036

International Standard Serial Number (ISSN)

  • 0323-3847

Digital Object Identifier (DOI)

  • 10.1002/bimj.4710350111

Citation Source

  • Scopus