Conduct of pharmacokinetic studies in target animal species - Scientific guideline
Table of contents
This document provides guidance and assistance to applicants in the design, execution and interpretation of pharmacokinetic investigations of a given active substance in the target species in relation to efficacy and safety issues.
Keywords: Pharmacokinetics, target animal species, veterinary
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Draft guideline on conduct of pharmacokinetic studies in target animal species - Revision 1 (PDF/172.56 KB)
Draft: consultation closed
First published: 21/11/2017
Last updated: 21/11/2017
Consultation dates: 20/11/2017 to 31/05/2018
EMEA/CVMP/EWP/133/1999 Rev.1 -
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Concept paper for the revision on the guideline for the conduct of pharmacokinetic studies in target animal species (PDF/101.23 KB)
Draft: consultation closed
First published: 03/02/2016
Last updated: 03/02/2016
Consultation dates: 03/02/2016 to 30/04/2016
EMA/CVMP/EWP/706701/2015