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Case studies: ANDA formulations can change FDA risk classification and prompt fed BE studies
Summary
Through three hypothetical ANDA case studies the presenter showed how test formulation complexity, pH modifiers, and modeling proposals can alter FDA risk classification and BE study expectations, sometimes leading the agency to request additional fed BE studies or data.
The presenter ran through three mock ANDA case studies to show how FDA classification and PSG recommendations can change after reviewing a generic applicant's formulation and data. In case 1, a class 4 drug with a simple RLD became high‑risk because the test product used complex amorphous solid dispersion methodologies and different polymers; pilot studies showed differing dissolution and inconsistent fasting versus fed outcomes, prompting submission of both fasting and fed BE studies.
In case 2 the applicant for a fixed‑dose combination submitted only a fasting BE study and proposed modeling in lieu of a fed BE study. FDA provisionally accepted the modeling approach but identified deficiencies and issued a letter requesting the applicant correct the modeling or perform a fed BE study. Case 3 showed that pH modifiers in the formulation materially affected fed‑condition performance: generics that contained pH modifiers consistently passed fasting and fed studies while those without them showed inconsistent food effects, leading FDA to recommend both fasting and fed BE studies for that drug.
