Conduct of efficacy studies for non-steroidal anti-inflammatory drugs (NSAIDs) - Scientific guideline
This document provides information and guidance on trial design and conduct, as well as on reporting standards for efficacy studies submitted in support of an application to authorise a new veterinary non-steroidal anti-inflammatory drug (NSAID), or to vary the indications of an already authorised NSAID.
Keywords: Veterinary medicinal products, non-steroidal anti-inflammatory drugs, efficacy.
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Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs (PDF/156.82 KB)
Adopted
First published: 24/01/2014
Last updated: 24/01/2014
Legal effective date: 01/08/2014
EMA/CVMP/EWP/1061/2001 -
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Overview of comments received on 'Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs (PDF/151.75 KB)
First published: 24/01/2014
Last updated: 24/01/2014
Legal effective date: 01/08/2014
EMA/CVMP/EWP/391540/2013 -
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Draft guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs (PDF/107.72 KB)
Draft: consultation closed
First published: 19/11/2012
Last updated: 19/11/2012
Consultation dates: 16/11/2012 to 31/05/2013
EMA/CVMP/EWP/1061/2001-CONSULTATION -
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Concept paper on proposed revision to the Guideline for the conduct of efficacy studies for NSAIDs (PDF/65.2 KB)
Draft: consultation closed
First published: 28/05/2010
Last updated: 28/09/2010
Consultation dates: 19/05/2010 to 30/11/2010
EMA/CVMP/EWP/62867/2009