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

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

Document history

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

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

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

AdoptedReference Number: EMA/CHMP/59169/2017

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

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

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

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

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.