Presentation Description: The FDA guidance, Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA, includes recommendations outlining approaches for establishing bioequivalence of additional strengths of a proposed modified release (MR) drug product for oral administration. In the past, the FDA recommended that in addition to acceptable in vivo bioequivalence studies on the recommended test strength and similar dissolution profiles for each strength, a generic formulation should also be compositional proportional across all strengths for the additional strengths to be considered equivalent to the test strength. The FDA’s current thinking places less emphasis on compositional proportionality requirements. Instead, the FDA recommends applicants provide rationale for their formulation based on the claimed drug release mechanism. De-emphasizing the recommendation that modified release products be compositional proportional across strengths provides flexibility to develop challenging generic MR products while requiring a higher level of evidence for bioequivalence demonstration.
Familiarize the attendee with FDA’s recommendations for establishing bioequivalence for additional strengths of MR products
Demonstrate an example of scenario where prior recommendations failed and the need for more modern recommendations
Demonstrate a case example of how the new recommendations will provide flexibility in designing challenging MR drug product platforms that are not dependent on compositional proportionality requirements.