Demonstration of efficacy for veterinary medicinal products containing antimicrobial substances

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CVMP/627/2001 Rev. 1
Published03/02/2016
Effective from01/08/2016
KeywordsAntimicrobial, pharmacokinetic/pharmacodynamic (PK/PD) relationship, clinical study, summary of product characteristics (SPC), veterinary medicinal product (VMP)
DescriptionThis 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.


Document history

Revision 1

Current version

PDF iconAdopted guideline

 

PDF iconOverview of comments

(second consultation)

 

PDF iconRevised draft guideline

 

PDF iconOverview of comments

 

PDF iconDraft guideline

 

PDF iconConcept paper

In operation: 01/08/2016

 

Published: 03/02/2016

 

Published: 04/03/2015

 

Published: 04/03/2015

 

Published: 29/05/2013

 

Published: 20/04/2011

First version PDF iconAdopted guideline In operation: 11/06/2003–01/08/2016


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