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Page 1
The Need for Pediatric Drug Development.
Ward RM, Benjamin DK Jr, Davis JM, Gorman RL, Kauffman R, Kearns GL, Murphy MD, Sherwin CMT. Ward RM, et al. Among authors: davis jm. J Pediatr. 2018 Jan;192:13-21. doi: 10.1016/j.jpeds.2017.08.011. Epub 2017 Sep 21. J Pediatr. 2018. PMID: 28942898 Free PMC article. No abstract available.
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: davis jm. Ther Innov Regul Sci. 2015 Sep;49(5):623-631. doi: 10.1177/2168479015597730. Ther Innov Regul Sci. 2015. PMID: 30227031
Development of a neonatal adverse event severity scale through a Delphi consensus approach.
Salaets T, Turner MA, Short M, Ward RM, Hokuto I, Ariagno RL, Klein A, Beauman S, Wade K, Thomson M, Roberts E, Harrison J, Quinn T, Baer G, Davis J, Allegaert K; International Neonatal Consortium. Salaets T, et al. Arch Dis Child. 2019 Dec;104(12):1167-1173. doi: 10.1136/archdischild-2019-317399. Epub 2019 Sep 19. Arch Dis Child. 2019. PMID: 31537552 Free PMC article.
Development of a Pediatric Adverse Events Terminology.
Gipson DS, Kirkendall ES, Gumbs-Petty B, Quinn T, Steen A, Hicks A, McMahon A, Nicholas S, Zhao-Wong A, Taylor-Zapata P, Turner M, Herreshoff E, Jones C, Davis JM, Haber M, Hirschfeld S. Gipson DS, et al. Among authors: davis jm. Pediatrics. 2017 Jan;139(1):e20160985. doi: 10.1542/peds.2016-0985. Pediatrics. 2017. PMID: 28028203 Free PMC article.
Necrotizing Enterocolitis: Using Regulatory Science and Drug Development to Improve Outcomes.
Caplan MS, Underwood MA, Modi N, Patel R, Gordon PV, Sylvester KG, McElroy S, Manzoni P, Gephart S, Chwals WJ, Turner MA, Davis JM; Necrotizing Enterocolitis Workgroup of the International Neonatal Consortium. Caplan MS, et al. Among authors: davis jm. J Pediatr. 2019 Sep;212:208-215.e1. doi: 10.1016/j.jpeds.2019.05.032. Epub 2019 Jun 22. J Pediatr. 2019. PMID: 31235383 No abstract available.
Chronic Pulmonary Insufficiency of Prematurity: Developing Optimal Endpoints for Drug Development.
Steinhorn R, Davis JM, Göpel W, Jobe A, Abman S, Laughon M, Bancalari E, Aschner J, Ballard R, Greenough A, Storari L, Thomson M, Ariagno RL, Fabbri L, Turner MA; International Neonatal Consortium. Steinhorn R, et al. Among authors: davis jm. J Pediatr. 2017 Dec;191:15-21.e1. doi: 10.1016/j.jpeds.2017.08.006. J Pediatr. 2017. PMID: 29173299 No abstract available.
Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials.
Davis JM, Baer GR, McCune S, Klein A, Sato J, Fabbri L, Mangili A, Short MA, Tansey S, Mangum B, Hokuto I, Nakamura H, Salaets T, Allegaert K, Yao L, Blum M, Toerner J, Turner M, Portman R; International Neonatal Consortium. Davis JM, et al. J Pediatr. 2020 Apr;219:243-249.e1. doi: 10.1016/j.jpeds.2019.09.060. Epub 2019 Nov 8. J Pediatr. 2020. PMID: 31708158 Free PMC article. No abstract available.
2,143 results