EMA Revealed First Guidelines on PBPK Modelling

EU regulatory authority European Medicines Agency (EMA) on 29th July 2016 revealed its first-ever draft guideline targeted on the use of physiologically-based pharmacokinetic ( PBPK ) modelling.

Via the use of specific software platforms, the models target to simulate the concentration of a drug in the body over time. EMA notices that the models are progressively used by drug developers for forecasting the interaction between drugs in the body or assisting to define the preliminary dose of a drug in a pediatric population or first in clinical trials.

“If PBPK modelling is designed to assist a regulatory decision, the PBPK platform requires to be qualified for the intended use and the predictive performance of the particular drug models has to be assessed,” EMA says.

And though PBPK modelling is described in various other EMA guidelines, this is the initial time the authority has particularly offer specific advice on what to include in a PBPK modelling report, to be able to enable for EMA to evaluate the predictive efficiency of the model.

The validation of PBPK platforms could take place via EMA’s qualification of new methodologies for drug development, the EMA says, observing that it can validate that the use of a particular method is appropriate in the context of R&D.

In addition, the guidance is designed to explain which supportive data are predicted to be able to qualify a PBPK platform for an intended objective.

The draft guideline also clears up how these designs can support making decisions in the context of a marketing authorisation application (MAA), and it provides guidance on the data that needs to be provided in a PBPK modelling report of a MAA dossier.

Responses on the draft guide must be sent to pkwpsecretariat@ema.europa.eu, by 31 January 2017.

Regulatory authority also states that it will arrange a workshop on 21 November 2016 to collect more responses on the draft and to bring together specialists from academia, industry and other authorities, along with PKPB software developers.