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Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children's Pediatric Innovation Research Forum.
Noel GJ, Nelson RM, Bucci-Rechtweg C, Portman R, Miller T, Green DJ, Snyder D, Moreno C, Hovinga C, Connor E. Noel GJ, et al. Among authors: nelson rm. Ther Innov Regul Sci. 2021 Jul;55(4):773-778. doi: 10.1007/s43441-021-00283-y. Epub 2021 Apr 2. Ther Innov Regul Sci. 2021. PMID: 33811302 Free PMC article.
Ethical considerations in conducting pediatric research.
Roth-Cline M, Gerson J, Bright P, Lee CS, Nelson RM. Roth-Cline M, et al. Among authors: nelson rm. Handb Exp Pharmacol. 2011;205:219-44. doi: 10.1007/978-3-642-20195-0_11. Handb Exp Pharmacol. 2011. PMID: 21882114
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: nelson rm. J Pediatr Gastroenterol Nutr. 2014 Jun;58(6):684-8. doi: 10.1097/MPG.0000000000000322. J Pediatr Gastroenterol Nutr. 2014. PMID: 24866782
Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014.
Offringa M, Davis JM, Turner MA, Ward R, Bax R, Maldonado S, Sinha V, McCune SK, Zajicek A, Benjamin DK Jr, Bucci-Rechtweg C, Nelson RM. Offringa M, et al. Among authors: nelson rm. Ther Innov Regul Sci. 2015 Sep;49(5):623-631. doi: 10.1177/2168479015597730. Ther Innov Regul Sci. 2015. PMID: 30227031
Extrapolation as a Default Strategy in Pediatric Drug Development.
Gamalo M, Bucci-Rechtweg C, Nelson RM, Vanh L, Porcalla A, Thackray H, Cooner F, Cutler L, Friend D, Portman R. Gamalo M, et al. Among authors: nelson rm. Ther Innov Regul Sci. 2022 Nov;56(6):883-894. doi: 10.1007/s43441-021-00367-9. Epub 2022 Jan 10. Ther Innov Regul Sci. 2022. PMID: 35006587
369 results