Challenges to the Therapeutic Pipeline for Irritable Bowel Syndrome: End Points and Regulatory Hurdles Michael Camilleri, Lin Chang Gastroenterology

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Challenges to the Therapeutic Pipeline for Irritable Bowel Syndrome: End Points and Regulatory Hurdles Michael Camilleri, Lin Chang Gastroenterology Volume 135, Issue 6, Pages 1877-1891 (December 2008) DOI: 10.1053/j.gastro.2008.09.005 Copyright © 2008 AGA Institute Terms and Conditions

Figure 1 The process recommended by the PRO guidance document for developing of new or for modifying existing instruments for clinical trials (reproduced from US Department of Health and Human Services FDA Center for Drug Evaluation and Research; US Department of Health and Human Services FDA Center for Biologics Evaluation and Research; US Department of Health and Human Services FDA Center for Devices and Radiological Health92). Gastroenterology 2008 135, 1877-1891DOI: (10.1053/j.gastro.2008.09.005) Copyright © 2008 AGA Institute Terms and Conditions