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Drug Industry Daily
May 31, 2012 | Vol. 11 No. 107
Final Guidance Gives Provisional Endpoints, Trial Designs for IBS Studies in Lieu of PRO Tools
The FDA has outlined provisional trial designs, study endpoints and efficacy analyses that can be used for testing and assessing new irritable bowel syndrome (IBS) drugs until a well-defined and reliable patient reported outcome (PRO) tool — the ideal efficacy assessment instrument — can be developed.
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