Concept paper for the revision on the guideline for the conduct of pharmacokinetic studies in target animal species

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Download document Concept paper for the revision on the guideline for the conduct of pharmacokinetic studies in target animal species
Reference number EMA/CVMP/EWP/706701/2015
Status draft: consultation closed
First published 03/02/2016
Last updated 03/02/2016

Summary

The guideline for the conduct of pharmacokinetic (PK) studies in target animal species was adopted in March 2000. Since its introduction, it has been referred to extensively in full application dossiers, but also in applications to vary existing marketing authorisations, e.g. addition of a new target species or route of administration.