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 - effective from 28/01/2022

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

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

Document history

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

AdoptedLegal effective date: 01/07/2019Reference Number: EMA/CVMP/016/2000 Rev. 3 corr. 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/755602/2017Summary:

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

Consultation dates: 12/04/2017 to 31/10/2017Draft: consultation closedReference 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

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

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

AdoptedReference Number: EMA/CVMP/016/00 Rev. 2

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

Consultation dates: 14/07/2010 to 31/10/2010Draft: consultation closedReference 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

AdoptedReference 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

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

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

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

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