Rajanikanth Madabushi, PhD, MBA: No financial relationships to disclose
This talk will discuss the Fit-for-Purpose (FFP) initiative which is a regulatory pathway for the acceptance of dynamic tools, also referred to as "reusable" models facilitating new drug development. The DMF Type V MMF submissions, recently introduced for ANDAs, are offering a sharable platform for in silico approaches acceptable for regulatory purposes with conceptual similarities with the FFP initiative. As such, lessons learned and case examples on the FFP initiative that could assist with the MMF implementation will be shared and discussed.
