Bioequivalence, Topical Corticosteroids, and Nonlinear Mixed Effect Modelling

Jonathan B. Skinner

This presentation will explain some of the historical background to the definition of bioequivalence and how it relates to the testing of topical cortisteroids in accordance with a recent FDA guidance. An old question will be shown to be also 'Hot'. While the testing involves difficult design questions, this presentation will focus on the analysis of dose-response data by mixed effect modelling with the Emax model:

Effect=(Maximum effect)x(Dose)/((Dose with half maximal effect)+(Dose)