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Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis-a global scientific discussion, part 1: efficacy endpoints and disease outcome assessments.
Sun H, Vesely R, Taminiau J, Szitanyi P, Papadopoulos EJ, Isaac M, Klein A, Uzu S, Griebel D, Mulberg AE; International Inflammatory Bowel Disease Working Group. Sun H, et al. J Pediatr Gastroenterol Nutr. 2014 Jun;58(6):679-83. doi: 10.1097/MPG.0000000000000306. J Pediatr Gastroenterol Nutr. 2014. PMID: 24866781
Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis-a global scientific discussion, part 2: data extrapolation, trial design, and pharmacokinetics.
Sun H, Vesely R, Nelson RM, Taminiau J, Szitanyi P, Isaac M, Klein A, Uzu S, Griebel D, Mulberg AE; International Inflammatory Bowel Disease Working Group. Sun H, et al. J Pediatr Gastroenterol Nutr. 2014 Jun;58(6):684-8. doi: 10.1097/MPG.0000000000000322. J Pediatr Gastroenterol Nutr. 2014. PMID: 24866782
Surrogate Endpoints in Pediatric Studies Submitted to the US FDA.
Green DJ, Sun H, Burnham J, Liu XI, van den Anker J, Temeck J, Yao L, McCune SK, Burckart GJ. Green DJ, et al. Among authors: sun h. Clin Pharmacol Ther. 2019 Mar;105(3):555-557. doi: 10.1002/cpt.1117. Epub 2018 Aug 9. Clin Pharmacol Ther. 2019. PMID: 30094815 Free PMC article. Review.
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