Demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Scientific guideline
This document provide guidance on the statistical principles to be considered in the design, conduct, analysis and evaluation of clinical trials to demonstrate efficacy and/or safety of an investigational veterinary pharmaceutical product in animals.
Keywords: Antimicrobial, pharmacokinetic/pharmacodynamic (PK/PD) relationship, clinical study, summary of product characteristics (SPC), veterinary medicinal product (VMP)
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Guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Revision 1 (PDF/219.92 KB)
Adopted
First published: 03/02/2016
Last updated: 03/02/2016
EMA/CVMP/627/2001 Rev.1 -
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Overview of comments received on the draft revised guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances (PDF/350.07 KB)
First published: 03/02/2016
Last updated: 03/02/2016
EMA/CVMP/EWP/374087/2015 -
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Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1 (PDF/244.96 KB)
Draft: consultation closed
First published: 19/12/2018
Consultation dates: 19/12/2018 to 31/08/2019
EMA/CVMP/EWP/755916/2016 -
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Overview of comments received on 'Guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances’ (PDF/532.15 KB)
First published: 04/03/2015
Last updated: 04/03/2015
EMA/CVMP/EWP/737951/2013 -
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Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Revision (PDF/220.56 KB)
Draft: consultation closed
First published: 29/05/2013
Last updated: 29/05/2013
Consultation dates: 29/05/2013 to 30/11/2013
EMA/CVMP/261180/2012 -
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Concept paper on the revision of the CVMP guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances (PDF/79.25 KB)
Draft: consultation closed
First published: 20/04/2011
Last updated: 20/04/2011
Consultation dates: 07/04/2011 to 31/07/2011
EMA/CVMP/EWP/760764/2010