A distribution-free procedure for the statistical analysis of bioequivalence studies

Author(s): Steinijans, V., Diletti, E.

Journal/Book: International Journal of Clinical Pharmacology, Therapy and Toxicology. 1992; 1: 37-43.

Abstract: In bioequivalence assessment, the consumer risk of erroneously accepting bioequivalence is of primary concern. In order to control the consumer risk, the decision problem is formulated with bioinequivalence as hypothesis and bioequivalence as alternative. In the parametric approach, a split into two one-sided test problems and application of twosample t-tests have been suggested. Rejection of both hypotheses at nominal a-level is equivalent to the inclusion of the classical (shortest) (1-2a) 100%-confidence interval in the bioequivalence range. This paper demonstrates that the rejection of the two one-sided hypotheses at nominal a-level by means of nonparametric Mann-Whitney-Wilcoxon tests is equivalent to the inclusion of the corresponding distribution-free (1-2a) 100%-confidence interval in the bioequivalence range. This distribution-free (nonparametric) approach needs weaker model assumptions and hence presents an alternative to the parametric approach.

Keyword(s): Bioequivalence

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