Conduct of bioequivalence studies for veterinary medicinal products - Scientific guideline

This document specifies requirements for the design, conduct, and evaluation of bioequivalence studies for pharmaceutical forms with systemic action. It also explains how in-vitro data in specific cases may be used to allow bridging of safety and efficacy data.

Keywords: Bioequivalence, pharmacokinetics, generic veterinary medicinal product, predefined acceptance criteria, biowaiver, in vitro dissolution tests

Current version (currently under revision)

Guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 4

Adopted Reference Number: EMA/CVMP/016/2000 Rev.4 Legal effective date: 28/01/2022

Document history - Revision 5

Concept paper for the revision of the guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/2000-Rev.4)

Draft: consultation closed Consultation dates: 26/07/2024 to 31/10/2024 Reference Number: EMA/CVMP/256158/2024 Summary:

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Document history

Guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3

Adopted Reference Number: EMA/CVMP/016/2000 Rev. 3 corr. Legal effective date: 01/07/2019 Summary:

Guideline on the conduct of bioequivalence studies for veterinary medicinal products

Overview of comments received on 'Guideline on the conduct of bioequivalence studies for veterinary medicinal products' (EMA/CVMP/016/00-Rev.3) - Revision 3

Reference Number: EMA/CVMP/755602/2017 Summary:

Overview of comments received on 'Guideline on the conduct of bioequivalence studies for veterinary medicinal products' (EMA/CVMP/016/00-Rev.3) - Revision 3

Draft guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3

Draft: consultation closed Consultation dates: 12/04/2017 to 31/10/2017 Reference Number: EMA/CVMP/EWP/016/00 Rev. 3

Concept paper for the revision of the CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3

Draft: consultation closed Consultation dates: 29/04/2016 to 31/07/2016 Reference Number: EMA/CVMP/EWP/707453/2015 Summary:

The current CVMP guideline for the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.2) was first adopted in January 2001 and revised in April 2011.

Guideline for the conduct of bioequivalence studies for veterinary medicinal products - Revision 2

Adopted Reference Number: EMA/CVMP/016/00 Rev. 2

Draft guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 2

Draft: consultation closed Consultation dates: 14/07/2010 to 31/10/2010 Reference Number: EMEA/CVMP/016/00 Rev. 2

Overview of comments received on guideline on the conduct of bioequivalence studies for veterinary medicinal products' (EMEA/CVMP/016/00-Rev.2-CONSULTATION) - Revision 2

Adopted Reference Number: EMA/CVMP/676396/2010

Concept paper on the revision of the guideline for the conduct of bioequivalence studies for veterinary medicinal products (EMEA/CVMP/016/00) - Revision 2

Reference Number: EMEA/CVMP/EWP/295306/2006

Guideline for the conduct of bioequivalence studies for veterinary medicinal products - Revision 1

Adopted Reference Number: EMEA/CVMP/016/00-cor-FINAL Legal effective date: 28/02/2001

Overview of comments received on draft guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 1

Reference Number: EMA/CVMP/561927/2009 Summary:

Overview of comments received on draft guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 1