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

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.