The bootstrap in bioequivalence studies.
In 1997, the U.S. Food and Drug Administration (FDA) suggested in its draft guidance the use of new concepts for assessing the bioequivalence of two drug formulations, namely, the concepts of population and individual bioequivalence. Aggregate moment-based and probability-based measures of bioequivalence were introduced to derive criteria in order to decide whether two formulations should be regarded as bioequivalent or not. The statistical decision may be made via a nonparametric bootstrap percentile interval. In this article, we review the history of population and individual bioequivalence with special focus on the role of the bootstrap in this context.
Bremen Institute for Prevention Research and Social Medicine, University of Bremen, Bremen, Germany. pigeot@bips.uni-bremen.de
Iris
I
Pigeot
Dieter
D
Hauschke
Jun
J
Shao
D006801:Humans; D015233:Models, Statistical; D011159:Population Surveillance / Q000379:methods; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*