Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective
Efthymios Manolis, Alfredo García‐Arieta, Anders H. Lindahl, Evangelos Kotzagiorgis, Jobst Limberg, Øyvind Holte, Paulo Jorge Pereira Alves Paixão, Carolien H. M. Versantvoort, Flora Musuamba Tshinanu, Kevin V. Blake, Michiel van den Heuvel · CPT Pharmacometrics & Systems Pharmacology · 2023
Model-informed drug development (MIDD) approaches receive wide regulatory acceptance in the European Medicines Agency (EMA) to support new drug development. For generic drugs, the European regulators have not reached a common position on how to use these methods. This commentary expands on the existing EMA regulatory framework for bioequivalence and physiological based pharmacokinetic (PBPK) modeling to propose conditions where mechanistic models could support or potentially waive clinical bioequivalence (BE)/bioavailability (BA) studies.