Journal of Pharmacokinetics and Biopharmaceutics

, Volume 20, Issue 5, pp 557–561 | Cite as

Sample size determination for bioequivalence assessment using a multiplicative model

  • Dieter Hauschke
  • Volker W. Steinijans
  • Edgar Diletti
  • Martin Burke
Short Communication Pharmacometrics

Abstract

In bioequivalence studies Cmax and AUCserve as the primary pharmacokinetic characteristics of rate and extent of absorption. Based on pharmacokinetic relationships and on empirical evidence, the distribution of these characteristics corresponds to a multiplicative model, which implies a logarithmic normal distribution in the case of a parametric analysis. Hence, consideration is given to exact and approximate formulas of sample sizes in the case of a multiplicative model.

Key words

bioequivalence bioequivalence range multiplicative model power sample size 

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Copyright information

© Plenum Publishing Corporation 1992

Authors and Affiliations

  • Dieter Hauschke
    • 1
  • Volker W. Steinijans
    • 1
  • Edgar Diletti
    • 1
  • Martin Burke
    • 1
  1. 1.Department of BiometryByk Gulden PharmaceuticalsKonstanzGermany

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