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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. Among authors: mulberg ae. 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. Among authors: mulberg ae. J Pediatr Gastroenterol Nutr. 2014 Jun;58(6):684-8. doi: 10.1097/MPG.0000000000000322. J Pediatr Gastroenterol Nutr. 2014. PMID: 24866782
Development of Celiac Disease Therapeutics: Report of the Third Gastroenterology Regulatory Endpoints and Advancement of Therapeutics Workshop.
Leffler D, Kupfer SS, Lebwohl B, Bugin K, Griebel D, Lathrop JT, Lee JJ, Mulberg AE, Papadopoulos E, Tomaino J, Crowe SE. Leffler D, et al. Among authors: mulberg ae. Gastroenterology. 2016 Sep;151(3):407-11. doi: 10.1053/j.gastro.2016.07.025. Epub 2016 Jul 25. Gastroenterology. 2016. PMID: 27456385 No abstract available.
Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development.
Mulugeta Y, Barrett JS, Nelson R, Eshete AT, Mushtaq A, Yao L, Glasgow N, Mulberg AE, Gonzalez D, Green D, Florian J, Krudys K, Seo S, Kim I, Chilukuri D, Burckart GJ. Mulugeta Y, et al. Among authors: mulberg ae. J Clin Pharmacol. 2016 Nov;56(11):1326-1334. doi: 10.1002/jcph.744. J Clin Pharmacol. 2016. PMID: 27040726 Free PMC article. Review.
73 results