Power of the two one-sided tests procedure in bioequivalence

  • Kem F. Phillips
Pharmacometrics

DOI: 10.1007/BF01063556

Cite this article as:
Phillips, K.F. Journal of Pharmacokinetics and Biopharmaceutics (1990) 18: 137. doi:10.1007/BF01063556

Abstract

The power of the two one-sided tests procedure for testing bioequivalence is derived from the bivariate noncentral tdistribution. Power curves are shown and their use in planning bioequivalence experiments discussed. Sample sizes computed in the usual manner from an analysis of variance are shown to be too small to assure a declaration of bioequivalence except under favorable conditions.

Key words

bioequivalence hypothesis testing power sample size 

Copyright information

© Plenum Publishing Corporation 1990

Authors and Affiliations

  • Kem F. Phillips
    • 1
  1. 1.Department of Clinical and Scientific AffairsPfizer PharmaceuticalsNew York

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