Strategic Considerations for Bridging

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.

Speaker:

Seth DePuy, PhD, Manager, Regulatory Affairs

View the other webinars in the series here:

• Pillars of Success for 505(b)(2) Drug Development
• Recovering from an Unsatisfactory/Disastrous Pre-IND Meeting