Statistical Interpretation of Add-on Study in Bioequivalence Trial

Abstract

Recently KFDA (2008) published the new regulations in bioequivalence trials. The important change of the newly amended regulations is to allow the add-on trial when the initial trial fails to prove the bioequivalence between two drugs. Some regulatory agencies (Canada, Japan and WHO) admit the add-on design, but some statistical problems like type I error rate inflation are still disputed. This paper provides the statistical model of the add-on design and tries to interpret the statistical properties of the current regulations about the add-on design by the simulation study.