From Bench To Approval: Smart IVBE Strategies For Complex Drugs

In vitro bioequivalence (IVBE) is rapidly reshaping how complex drug products move from development to regulatory approval. This session explores how scientifically robust, clinically meaningful in vitro strategies can replace traditional in vivo bioequivalence studies — when designed with the right regulatory mindset. Drawing on real-world experience, the discussion explains what makes an IVBE approach credible in the eyes of regulators and where these strategies are most effective, particularly for locally acting products such as inhaled, nasal, topical, and ophthalmic therapies.

The presentation breaks down the six pillars of a successful IVBE program, from deep product and device understanding to risk-based testing, clinically relevant endpoints, and truly discriminatory analytical methods. It also addresses common pitfalls, including overly idealized test conditions, weak method sensitivity, and failure to account for human factors in device use. Through practical examples and a detailed inhalation case study, attendees gain insight into how to align in vitro data with real-world clinical performance. The result is a clearer framework for building IVBE packages that are both scientifically defensible and regulator-ready.

Access the on-demand webinar to learn how to design IVBE strategies that accelerate development without compromising confidence.