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Journal of Pharmacokinetics and Biopharmaceutics

, Volume 25, Issue 6, pp 753–765 | Cite as

A Note on Sample Size Determination for Bioequivalence Studies with Higher-Order Crossover Designs

  • Keh-Wei Chen
  • Shein-Chung Chow
  • Gang Li
Article

Abstract

Similar to Liu and Chow, approximate formulas for sample size determination are derived based on Schuirmann's two one-sided tests procedure for bioequiealence 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.

sample size higher order crossover design power bioequivalence 

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Copyright information

© Plenum Publishing Corporation 1997

Authors and Affiliations

  • Keh-Wei Chen
    • 1
  • Shein-Chung Chow
    • 2
  • Gang Li
    • 3
  1. 1.Department of Medical AffairsPasteur Merieux ConnaughtSwiftwater
  2. 2.Biostatistics and Data ManagementCovance Clinic and Periapproval Service, Inc.Princeton
  3. 3.Department of Biostatistics, School of Public HealthUniversity of CaliforniaLos Angeles

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