Steps Toward Harmonization for Clinical Development of Medicines in Pediatric Ulcerative Colitis - A Global Scientific Discussion, Part 1: Efficacy Endpoints and Disease Outcome Assessments
2014
Abstract
Partial extrapolation of efficacy from informative adult studies may be appropriate. Clinical studies in pediatric UC may include initial dose-finding studies and exposure-response modeling followed by an efficacy and safety study to further explore the exposure-response relation.