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. 1992 Oct;20(5):557-61.
doi: 10.1007/BF01061471.

Sample size determination for bioequivalence assessment using a multiplicative model

D Hauschke  1 , V W Steinijans, E Diletti, M Burke
Affiliations

Sample size determination for bioequivalence assessment using a multiplicative model

D Hauschke et al. J Pharmacokinet Biopharm. 1992 Oct.

Abstract

In bioequivalence studies Cmax and AUC serve 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.

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