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 2016-02-03
Last updated 2016-02-03

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.