A Q+A With Copley’s Clair Brooks on Alternative BE Approches in New FDA Guidance

In our article with OINDPnews, we explore the FDA’s updated guidance for orally inhaled and nasal drug products (OINDPs), issued on 15th February 2024. The guidance introduces new strategies for demonstrating bioequivalence (BE) without the need for clinical endpoint trials. Clair Brooks, our Applications Specialist, shares her insights on these evolving test methods, with a focus on realistic aerodynamic particle size distribution (APSD) measurement and the push for stronger in vitro-in vivo correlation (IVIVC).