Reporting the results of population pharmacokinetic analyses - Scientific guideline

This 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).

Keywords: Nonlinear mixed effects modelling, population modelling, pharmacokinetics, pharmacodynamics, PKPD, analysis plan, data description, model selection, model evaluation, reporting, population pharmacokinetics

Current effective version

Guideline on reporting the results of population pharmacokinetic analyses

Adopted Reference Number: CHMP/EWP/185990/06 Legal effective date: 01/01/2008

Document history - First version (current)

Guideline on reporting the results of population pharmacokinetic analyses

Adopted Reference Number: CHMP/EWP/185990/06 Legal effective date: 01/01/2008

Overview of comments received on the draft guideline on reporting the results of population pharmacokinetic analyses

Reference Number: EMEA/CHMP/EWP/260830/2007

Draft guideline on reporting the results of population pharmacokinetic analyses

Draft: consultation closed Reference Number: EMEA/CHMP/EWP/185990/2006