On July 21st, the EMA issued a draft Guidance entitled “Guideline on the qualification and reporting of
physiologically based pharmacokinetic (PBPK) modelling and simulation”.
The document is open for public consultation and feedback until 31 January 2017.
A growing number of regulatory submissions include Physiologically Based Pharmacokinetic (PBPK) models that require the use of specialised software platforms. If PBPK modelling is intended to support a regulatory decision, the PBPK platform needs to be qualified for the intended use and the predictive performance of the specific drug models needs to be evaluated. While PBPK modelling is presently mentioned in several existing EMA guidelines, this is the first to specifically provide detailed advice on what to include in a PBPK modelling report, to allow assessment of the predictive performance of the drug model. In addition, this document aims to clarify which supportive data are expected in order to qualify a PBPK platform for an intended purpose.