Conduct of pharmacokinetic studies in target animal species - Scientific guideline

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

Current effective version

Guideline on the conduct of pharmacokinetic studies in target animal species - Revision 1

Adopted Reference Number: EMA/CVMP/EWP/133/1999-Rev.1 Legal effective date: 01/07/2024

Document history

Guideline on the conduct of pharmacokinetic studies in target animal species - Revision 1

Adopted Reference Number: EMA/CVMP/EWP/133/1999-Rev.1 Legal effective date: 01/07/2024

Overview of comments received on Guideline on the conduct of pharmacokinetic studies in target animal species (EMEA/CVMP/EWP/133/1999-Rev.1)

Reference Number: EMA/CVMP/EWP/326568/2018

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

Draft: consultation closed Consultation dates: 20/11/2017 to 31/05/2018 Reference Number: EMEA/CVMP/EWP/133/1999 Rev.1 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.

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

Draft: consultation closed Consultation dates: 03/02/2016 to 30/04/2016 Reference Number: EMA/CVMP/EWP/706701/2015 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.

Guidelines for the conduct of pharmacokinetic studies in target animal species

Adopted Reference Number: EMEA/CVMP/133/99 Legal effective date: 08/09/2000