Abstract
In bioequivalence studies C max 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.
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Hauschke, D., Steinijans, V.W., Diletti, E. et al. Sample size determination for bioequivalence assessment using a multiplicative model. Journal of Pharmacokinetics and Biopharmaceutics 20, 557–561 (1992). https://doi.org/10.1007/BF01061471
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DOI: https://doi.org/10.1007/BF01061471