FDA, however, does not require that bioequivalence among generic copies of the same brand name drug be demonstrated. As a result, it is a concern whether these generic drugs can be used interchangeably. To address this question, the concepts of population bioequivalence for drug prescribability ...
Methodology has been proposed for evaluating switchability of two formulations of a drug that encompasses bioequivalence aspects using Dragalin and Fedorov's application of the Kullback- Leibler Divergence (KLD) and a metric developed by the Food and Drug Administration (FDA) as measures of discrepanc...
In all, 28 data sets from 20 replicate crossover bioequivalence studies have been analyzed (n = 12芒聙聯96) using the statistical methodology in the most recent FDA draft guidance. The results are presented below.Review of the database reveals many interesting features, most notably the lack ...