Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation - Scientific guideline

The aim of this guideline is to describe the expected content of physiologically based pharmacokinetic (PBPK) modelling and simulation reports included in regulatory submissions, such as applications for authorisation of medicinal products, paediatric investigation plans and clinical trial applications. This includes the documentation needed to support the qualification of a PBPK platform for an intended use. The guideline applies both to commercially available platforms and to in-house built platforms.

Keywords: Pharmacokinetics, modelling, simulation, qualification, predictive performance