On assessment of bioequivalence under a higher-order crossover design.

Published

Journal Article (Review)

In bioavailability studies of two formulations of a drug, the standard two-sequence, two-period crossover design is usually considered to assess bioequivalence. The standard two-sequence, two-period crossover design, however, may not be useful when differential carryover effects are present. In addition, it does not provide independent estimates of intrasubject variabilities for the two formulations. To overcome these problems, alternatively, a higher-order crossover design may be considered. In this paper, we derive statistical methods based on Schuirmann's two one-sided tests procedure for assessing bioequivalence for some commonly used higher-order crossover designs. Four designs, including Balaam's design, the two-sequence dual design, and two four-period designs (with two and four sequences), are considered. The relative merits of these designs as compared to the standard two-sequence, two-period design are discussed. Two examples concerning bioequivalence are used to illustrate the use of these methods.

Full Text

Duke Authors

Cited Authors

  • Chow, SC; Liu, JP

Published Date

  • 1992

Published In

Volume / Issue

  • 2 / 2

Start / End Page

  • 239 - 256

PubMed ID

  • 1300216

Pubmed Central ID

  • 1300216

International Standard Serial Number (ISSN)

  • 1054-3406

Digital Object Identifier (DOI)

  • 10.1080/10543409208835042

Language

  • eng

Conference Location

  • England