Choice of student's t-or wilcoxon-based confidence intervals for assessment of average bioequivalence

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Abstract
An open question in the analysis of average bioequivalence is whether the nonparametric (Wilcoxon) or parametric (0 approaches to two one-sided tests is preferable. Previous work has made particular distributional assumptions as to the distribution of AUC anc C max. Instead, we simulate data according to a pharmacokinetic model for an immediate-release formulation. We find that both approaches have estimated level consistent with the nominal 5%. The only concern is a possible anticonservativeness of the parametric approach for C max. Further, the nonparametric approach is consistently less powerful than the parametric for the cases studied