Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation - Scientific guideline
Table of contents
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
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Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation (PDF/213.91 KB)
Adopted
First published: 13/12/2018
Legal effective date: 01/07/2019
EMA/CHMP/458101/2016 -
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Overview of comments received on 'Guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation' (EMA/CHMP/458101/2016) (PDF/654.96 KB)
Adopted
First published: 01/07/2020
EMA/CHMP/59169/2017 -
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Draft guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation (PDF/253.87 KB)
Draft: consultation closed
First published: 29/07/2016
Last updated: 29/07/2016
Consultation dates: 29/07/2016 to 31/01/2017
EMA/CHMP/458101/2016 -
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Concept paper on qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and analyses (PDF/89.02 KB)
Draft: consultation closed
First published: 27/06/2014
Last updated: 27/06/2014
Consultation dates: 27/06/2014 to 30/09/2014
EMA/CHMP/211243/2014