|
1000
|
Abstract/Summary
|
-
Model- informed drug development (MIDD) approaches receive wide regulatory acceptance in the European Medicines Agency (EMA) to support new drug devel-opment. For generic drugs, the European regulators have not reached a common position on how to use these methods. This commentary expands on the exist-ing EMA regulatory framework for bioequivalence and physiological based phar-macokinetic (PBPK) modeling to propose conditions where mechanistic models could support or potentially waive clinical bioequivalence (BE)/bioavailability (BA) studies.
|
