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Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response.
Earp JC, Mehrotra N, Peters KE, Fiorentino RP, Griebel D, Lee SC, Mulberg A, Röhss K, Sandström M, Taylor A, Tornøe CW, Wynn EL, Van der Walt JS, Garnett C. Earp JC, et al. Among authors: mulberg a. J Pediatr Gastroenterol Nutr. 2017 Sep;65(3):272-277. doi: 10.1097/MPG.0000000000001467. J Pediatr Gastroenterol Nutr. 2017. PMID: 27875488
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
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
Drug development: The use of unlicensed/off-label medicines in pediatrics.
Yamashiro Y, Martin J, Gazarian M, Kling S, Nakamura H, Matsui A, Cucchiara S, Aloi M, Wynn EL, Mulberg AE. Yamashiro Y, et al. Among authors: mulberg ae. J Pediatr Gastroenterol Nutr. 2012 Nov;55(5):506-10. doi: 10.1097/MPG.0b013e318272af1f. J Pediatr Gastroenterol Nutr. 2012. PMID: 22983373 No abstract available.
Proceedings From FDA/A.S.P.E.N. Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products, October 29, 2013.
Teitelbaum DH, Guenter P, Griebel D, Abrams SA, Bark S, Baker M, Berry KL, Bistrian BR, Brenna JT, Bonnot D, Carpentier YA, Deckelbaum RJ, Hise M, Koletzko B, Mirtallo JM, Mulberg AE, O'Reilly RC, Shaffer J, von Kleist E, Zaloga GP, Ziegler TR. Teitelbaum DH, et al. Among authors: mulberg ae. JPEN J Parenter Enteral Nutr. 2015 Sep;39(7):768-86. doi: 10.1177/0148607114560825. Epub 2014 Dec 4. JPEN J Parenter Enteral Nutr. 2015. PMID: 25475623 Free article.
77 results