Strategic Considerations for Bridging
Date: Tuesday, May 2, 2023
Speaker: Seth DePuy, PhD, Manager, Regulatory Affairs
This presentation is part of a series of webinars on 505(b)(2) NDA drug development that highlights the diversity, simplicity, and complexity of the 505(b)(2) application process. This session covers bridging studies, with a focus on the design and requirements for clinical/pharmacokinetic studies. The bridging studies discussed include comparative bioavailability/bioequivalence studies, PK bridges, CMC bridges, nonclinical safety bridges, “paper” bridges, and clinical safety bridges.
View the other webinars in the series here: