Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods

The transition of BE recommendations for locally-acting inhalation and nasal products to option-based frameworks has opened new opportunities by incorporating innovative in vitro, in vivo, and in silico methods as alternatives to comparative clinical endpoint BE studies. These advanced methodologies offer promising pathways for more efficient generic product development, though they require thoughtful implementation to maximize their potential. This workshop will harness collective expertise to identify best practices and develop strategic approaches that optimize study design, eliminate redundancies, and enhance evaluation efficiency—ultimately supporting first cycle approvals while addressing unique considerations for products with compositional differences.