CMC Workshop: From Drug Development to Global Supply to Patients

Bioequivalence (BE) studies are typically performed following CMC changes either as bridge studies between clinical trial and to-be-marketed formulations or during lifecycle management (post-approval changes). In addition, BE studies are also performed to support Biowaiver strategy for combination products. The design, performance, and evaluation of bioequivalence studies have received major attention lately. This session proposes to focus on the difference in bioequivalence studies requirements across regions/countries based on the more general and global requirements.