A note on sample size determination for bioequivalence studies with high-order crossover designs.


Journal Article

Similar to Liu and Chow, approximate formulas for sample size determination are derived based on Schuirmann's two one-sided tests procedure for bioequivalence studies for the additive and the multiplicative models under various higher order crossover designs for comparing two formulations of a drug product. The higher order crossover designs under study include Balaam's design, the two-sequence dual design, and two four-period designs (with two and four sequences), which are commonly used for assessment of bioequivalence between formulations. The derived formulas are simple enough to be carried out with a pocket calculator. The number of subjects required for each of the four higher order designs are tabulated for selected powers and various parameter values.

Full Text

Duke Authors

Cited Authors

  • Chen, KW; Chow, SC; Li, G

Published Date

  • December 1997

Published In

Volume / Issue

  • 25 / 6

Start / End Page

  • 753 - 765

PubMed ID

  • 9697082

Pubmed Central ID

  • 9697082

International Standard Serial Number (ISSN)

  • 0090-466X

Digital Object Identifier (DOI)

  • 10.1023/a:1025738019069


  • eng

Conference Location

  • United States