Current Issues of Individual Bioequivalence

Abstract

Since the concepts of switchability and individual bioequivalence were defined by Anderson and Hauck in 1990 (1), there have been numerous statistical criteria and methods developed to assess individual bioequivalence. It is this author's opinion, however, that the initial groundwork has not been set by which to evaluate these criteria and methods. What follows is a suggestion of the underlying framework that should be considered before additional criteria and methods are developed. It is a straightforward translation of the concepts of therapeutic index, titration, within-patient variability, and satisfactory efficacy/safety profile for an individual patient. Once the underlying pharmacological framework is set, statisticians can develop methods to allow assessment of the specified criteria.