Qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

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Current version

Draft guideline

Deadline for comments: 31/01/2017
Reference numberEMA/CHMP/458101/2016
Published29/07/2016
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KeywordsPharmacokinetics, modelling, simulation, qualification, predictive performance
DescriptionThe 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.


Document history

First version 

Current version

Draft guideline


 

Concept paper

Published: 01/08/2016
Deadline for comments: 31/01/2017


 

Published: 27/06/2014


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