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.

 

Current version - effective from 28/01/2022

Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs - Revision 1

Adopted Reference Number: EMA/CVMP/EWP/1061/2001 Rev.1 Legal effective date: 28/01/2022

Document history

Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs

Adopted Reference Number: EMA/CVMP/EWP/1061/2001 Legal effective date: 01/08/2014 Summary:

The objective of this guideline is to specify recommendations for the design, conduct, and evaluation of studies for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) to be provided in support of an application to register a new NSAID, or to vary the indications of an already authorised NSAID. The guideline provides recommendations on how to demonstrate the pharmacological characteristics for the NSAID under study through pre-clinical studies as well as how to appropriately demonstrate clinical efficacy and safety through clinical studies where the selection of control and efficacy endpoints is regarded as key issues for obtaining conclusive information.

Overview of comments received on 'Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs

Reference Number: EMA/CVMP/EWP/391540/2013 Legal effective date: 01/08/2014

Draft guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs

Draft: consultation closed Consultation dates: 16/11/2012 to 31/05/2013 Reference Number: EMA/CVMP/EWP/1061/2001-CONSULTATION Summary:

The objective of this guideline is to specify recommendations for the design, conduct, and evaluation of studies for non-steroidal anti-inflammatory drugs (NSAIDs) in support of an application to register a new NSAID, or to vary the indications of an already authorised NSAID.

Concept paper on proposed revision to the Guideline for the conduct of efficacy studies for NSAIDs

Draft: consultation closed Consultation dates: 19/05/2010 to 30/11/2010 Reference Number: EMA/CVMP/EWP/62867/2009

Superseded documents

Guideline for the conduct of efficacy studies for non steroidal anti inflammatory drugs

Adopted Reference Number: EMEA/CVMP/237/01 Legal effective date: 05/06/2002