Biowaivers enable faster, more efficient development timelines, allowing developers to bypass costly and time-consuming in vivo bioequivalence studies.
However, for complex drug products, robust in vitro bioequivalence (IVBE) strategies are required to credibly support clinical bioequivalence waivers.
In this webinar, Dr. Yannick Baschung will discuss when IVBE can credibly replace clinical bioequivalence — and when it cannot — for locally acting and complex drug products. The session will cover key analytical tools, performance tests, and study design principles used to demonstrate equivalence, with a strong focus on linking critical quality attributes (CQAs), risk assessment, and real-world product performance.
Through practical examples of common pitfalls and how to avoid them, along with a real-world case study, attendees will gain insight into how to build robust, inspection-ready IVBE data packages that can support clinical bioequivalence waivers and accelerate development.
Key Learning Objectives
- When biowaivers are scientifically and regulatorily justified—and when they are not, based on product complexity and decision criteria
- How to design fit-for-purpose IVBE strategies by linking CQAs, risk assessment, and real-world product performance
- How to avoid common IVBE pitfalls and generate robust, inspection-ready IVBE data that can support clinical bioequivalence waivers
