Reporting the results of population pharmacokinetic analyses

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Current effective version

Adopted guideline

Reference numberCHMP/EWP/185990/06
Published21/06/2007
Effective from01/01/2008
KeywordsNonlinear mixed effects modelling, population modelling, pharmacokinetics, pharmacodynamics, PKPD, analysis plan, data description, model selection, model evaluation, reporting, population pharmacokinetics
DescriptionThis document provides guidance on how to present the results of a population pharmacokinetic analysis, in order to provide a level of details that will enable a secondary evaluation (i.e. assessment by regulatory authorities of the conducted analysis and conclusions drawn).


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline

In operation: 01/01/2008–present


Published: 21/06/2007


Published: 29/06/2006


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