Current Use of Physiologically Based Pharmacokinetic modeling in New Medicinal Product Approvals at EMA.

ABSTRACT: Physiologically Based Pharmacokinetic (PBPK) Models are routinely used in drug development and therefore appear frequently in marketing authorization applications (MAAs) to the European Medicines Agency (EMA). For a model to be a key source of evidence for a regulatory decision, it must be considered qualified for the intended use. Advice on the data expected to allow qualification of a PBPK model or platform is provided in the EMA Guideline on the reporting of PBPK modeling and simulation. The present study is an EMA review of the use of PBPK models in submitted MAAs in 2022 and 2023 focussing on the concept of qualification and the reasons why models were not considered qualified. A review of the 95 MAAs with a "full" legal basis approved during these years showed that 25 of them contain

SUBMITTER: Paul P 

PROVIDER: S-EPMC11835421 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature