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

2. 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  , DOI: ( /j.gastro )
Copyright © 2008 AGA Institute Terms and Conditions