Concept paper on qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and analyses

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Download document Concept paper on qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and analyses
Reference number EMA/CHMP/211243/2014
Status draft: consultation open
First published 27/06/2014
Last updated 27/06/2014
Consultation start date 27/06/2014
Consultation end date 30/09/2014
Email address for submissions pkwp@ema.europa.eu

Summary

This concept paper proposes the drafting of a guideline on how to report the results from and performance of a physiologically based pharmacokinetic (PBPK) analysis.