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