Consistency of the bootstrap procedure in individual bioequivalence
Recently, the concepts of population and individual bioequivalence have been proposed for assessing the bioequivalence of two drug formulations. Moment-based and probability-based measures of bioequivalence have led to criteria for deciding whether two formulations should be regarded as bioequivalent or not. The US Food and Drug Administration (1997) guidance recommended the use of bootstrap percentile intervals for this purpose. In this paper, we discuss theoretical…