Reporting the results of population pharmacokinetic analyses

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Current effective version

Adopted guideline

Reference numberCHMP/EWP/185990/06
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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