Biowaivers based on the Bioclassification System (BCS), International Harmonisation of Requirements (ICH M9)

This webinar will provide a structured and practical overview of Bioclassification System (BCS)-based biowaivers under ICH M9. BCS-based biowaivers are an important scientific approach to avoid unnecessary in vivo bioequivalence studies, while maintaining confidence in product performance. However, their application requires a clear understanding of solubility, permeability, formulation prerequisites, and dissolution behavior. The event will explain the underlying scientific concepts, decision logic, and common pitfalls using practical examples. Special emphasis will be placed on dissolution as a key link between the drug substance, the formulation, and in vivo performance.

Moderator:

- Horst-Dieter Friedel, Former Director - retired, Worked for Bayer AG, Chair of FIP SIG Regulatory Sciences and Quality, Germany

Panellist:

- Hiroyuki Yoshida, Chief of the First Section, National Institute of Health Sciences, Member of FIP Focus Group Dissolution/Drug Release, Japan