Conduct of bioequivalence studies for veterinary medicinal products
Table of contents
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, biowaiver, BCS-based biowaiver, in vitro dissolution, generics, veterinary medicinal product (VMP)
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Guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3 (PDF/429.46 KB)
Adopted
First published: 19/12/2018
Last updated: 24/01/2020
Legal effective date: 01/07/2019
EMA/CVMP/016/2000 Rev. 3 corr. -
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Overview of comments received on 'Guideline on the conduct of bioequivalence studies for veterinary medicinal products' (EMA/CVMP/016/00-Rev.3) - Revision 3 (PDF/101.82 KB)
First published: 19/12/2018
EMA/CVMP/755602/2017 -
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Draft guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3 (PDF/334.49 KB)
Draft: consultation closed
First published: 24/04/2017
Last updated: 24/04/2017
Consultation dates: 12/04/2017 to 31/10/2017
EMA/CVMP/EWP/016/00 Rev. 3 -
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Concept paper for the revision of the CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3 (PDF/96.14 KB)
Draft: consultation closed
First published: 29/04/2016
Last updated: 29/04/2016
Consultation dates: 29/04/2016 to 31/07/2016
EMA/CVMP/EWP/707453/2015 -
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Guideline for the conduct of bioequivalence studies for veterinary medicinal products - Revision 2 (PDF/297.34 KB)
Adopted
First published: 20/04/2011
Last updated: 20/04/2011
EMA/CVMP/016/00 Rev. 2 -
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Draft guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 2 (PDF/276.72 KB)
Draft: consultation closed
First published: 16/03/2009
Last updated: 19/07/2010
Consultation dates: 14/07/2010 to 31/10/2010
EMEA/CVMP/016/00 Rev. 2 -
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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 (PDF/470.92 KB)
Adopted
First published: 20/04/2011
Last updated: 20/04/2011
EMA/CVMP/676396/2010 -
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Concept paper on the revision of the guideline for the conduct of bioequivalence studies for veterinary medicinal products (EMEA/CVMP/016/00) - Revision 2 (PDF/35.18 KB)
First published: 18/12/2006
Last updated: 18/12/2006
EMEA/CVMP/EWP/295306/2006 -
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Guideline for the conduct of bioequivalence studies for veterinary medicinal products - Revision 1 (PDF/83.47 KB)
Adopted
First published: 09/01/2001
Last updated: 09/01/2001
Legal effective date: 28/02/2001
EMEA/CVMP/016/00-cor-FINAL -
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Overview of comments received on draft guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 1 (PDF/680.65 KB)
First published: 03/11/2010
Last updated: 03/11/2010
EMA/CVMP/561927/2009