Draft guideline on conduct of pharmacokinetic studies in target animal species - Revision 1

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Document details

Download document Draft guideline on conduct of pharmacokinetic studies in target animal species - Revision 1
Reference number EMEA/CVMP/EWP/133/1999 Rev.1
Status draft: consultation open
First published 2017-11-21
Last updated 2017-11-21
Consultation start date 2017-11-20
Consultation end date 2018-05-31
Email address for submissions vet.guidelines@ema.europa.eu

Summary

The objectives of this guidance are to specify the pharmacokinetic factors to be investigated, acknowledging that this will depend on the active substance and its use, and to provide recommendations for the conduct of pharmacokinetic studies for the purpose of supporting the clinical part of the dossier for a veterinary pharmaceutical product. In addition, general guidance is given on pharmacokinetic-pharmacodynamic modelling and population pharmacokinetics, should applicants opt to pursue these approaches.