Testing Population and Individual Bioequivalence: A Hierarchical Bayesian Approach

The US Food and Drug Administration has recommended statistical guidelines that introduce two new bioequivalence criteria: population bioequivalence (PBE) and individual bioequivalence (IBE). In this paper we propose a hierarchical Bayesian methodology for evaluating these recently introduced criteria. We derive the joint posterior distribution of the parameters involved in a crossover design and propose two Bayesian testing procedures for bioequivalence. The method is also extended to incorporate the t distribution in order to facilitate a more robust approach. All methods are illustrated using a popular dataset. ∗Department of Mathematics and Statistics, Georgia State University, Atlanta, GA, 30303-3083, USA, Email: [email protected] †Department of Statistics, Athens University of Economics and Business, Greece, e-mail: [email protected].