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Application of Information Theory to Bio-Equivalence Problem

Adnan M Awad

The statistics of bioequivalence testing have received much attention in the literature. However, there is an ignorance of checking the validity of some of the underlying assumptions imposed on some of these tests. In this paper we review the mostly used tests. Moreover, we introduce Shannon bio-equivalence index and the concept of (1-β) 100% Shannon equivalent distributions and apply it together with a bootstrap method to test average bioequivalence of two formulations. An illustrative example is considered to compare the results of the suggested test with those that are given in the literature. The results of suggested test agree with those in the literature.