This Concept Paper proposes the drafting of a guideline on how to report the results from and performance of a Physiologically-based Pharmacokinetic (PBPK) analysis. PBPK analysis is utilised in a growing proportion of applications for marketing authorisation of new chemical entities. Systems pharmacology models in general are expected to become more important in drug development.
PBPK is presently mentioned in several guidelines including the Guideline on the Evaluation of the Pharmacokinetics of Medicinal products in Patients with Impaired Hepatic Function (CPMP/EWP/2339/02), the Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products (EMA/CHMP/37646/2009) and the Guideline on the investigation of drug interactions (CPMP/EWP/560/95/Rev. 1 Corr.*). PBPK will also be included as a tool in upcoming new guidelines and guideline revision applications for marketing of new chemical entities.