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

Current effective version

Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

Adopted Reference Number: EMA/CHMP/458101/2016 Legal effective date: 01/07/2019

Document history

Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

Adopted Reference Number: EMA/CHMP/458101/2016 Legal effective date: 01/07/2019

Overview of comments received on 'Guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation' (EMA/CHMP/458101/2016)

Adopted Reference Number: EMA/CHMP/59169/2017

Draft guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

Draft: consultation closed Consultation dates: 29/07/2016 to 31/01/2017 Reference Number: EMA/CHMP/458101/2016 Summary:

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.

Concept paper on qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and analyses

Draft: consultation closed Consultation dates: 27/06/2014 to 30/09/2014 Reference Number: EMA/CHMP/211243/2014 Summary:

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.