Conduct of bioequivalence studies for veterinary medicinal products - Scientific guideline
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, generic veterinary medicinal product, predefined acceptance criteria, biowaiver, in vitro dissolution tests
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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