Sample size determination for bioequivalence assessment using a multiplicative model
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 wordsbioequivalence bioequivalence range multiplicative model power sample size
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