Statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals) - Scientific guideline
Table of contents
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: Veterinary medicinal products, statistical principles, pre-clinical studies, clinical trials, study design, study conduct, data analysis, reporting.
-
List item
Guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals) (PDF/274.21 KB)
Adopted
First published: 23/01/2012
Last updated: 23/01/2012
Legal effective date: 01/08/2012
Consultation dates: 10/01/2012 to 31/07/2012
EMA/CVMP/EWP/81976/2010 -
List item
Overview of comments received on 'Guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals)' (PDF/328.59 KB)
First published: 23/01/2012
Last updated: 23/01/2012
EMA/CVMP/EWP/249785/2011 -
List item
Draft guideline on statistical principles for veterinary clinical trials (PDF/340.92 KB)
Draft: consultation closed
First published: 27/09/2010
Last updated: 27/09/2010
Consultation dates: 15/09/2010 to 31/03/2011
EMA/CVMP/EWP/81976/2010 -
List item
Concept paper on the revision of the guideline on statistical principles for veterinary clinical trials (EMEA/CVMP/816/00) (PDF/43.34 KB)
First published: 22/06/2009
Last updated: 22/06/2009
EMEA/CVMP/EWP/37388/2009