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 closed
First published 2014-06-27
Last updated 2014-06-27

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.