Bioequivalence Guidances from FDA and EMA (Ep. 6)

Thank you to everyone who sent me feedback on this podcast. This episode is based on a suggestion from Drew. In this episode, I discuss bioequivalence studies and generic drug development. I will refer to guidance documents from both the European Medicines Agency or EMA and the US Food and Drug Administration or FDA. First, I will start with a discussion of the definition of bioequivalence or BE. Then I will discuss the statistical basis for bioequivalence and how you can leverage that for study design. And I will end with some unique challenges related to bioequivalence. Throughout, I will give practical suggestions based on my experiences in the past with BE studies. Links discussed in the show: • EMA guidance on bioequivalence • FDA guidance on statistical approaches to bioequivalence (December 2022) • FDA statistical approaches to BE (January 2001) • FDA guidance on BE studies (2022) • FDA product-specific guidances on BE • Lecture from Helmut Schütz on finding intra-subject variability (or CV%) for power calculations • PowerTOST R Package • You can connect with me on LinkedIn and send me a message • Send me a message • Sign up for my newsletter Copyright Teuscher Solutions LLC All Rights Reserved