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Enrollment of Neonates in More Than One Clinical Trial.
Davis JM, Baer GR, Portman R, Nelson R, Storari L, Aranda JV, Bax R, Zajicek A, Klein A, Turner M, Baygani S, Thomson M, Allegaert K; International Neonatal Consortium. Davis JM, et al. Clin Ther. 2017 Oct;39(10):1959-1969. doi: 10.1016/j.clinthera.2017.09.006. Epub 2017 Oct 4. Clin Ther. 2017. PMID: 28987269 Free article. Review.
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.
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.
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
Meeting the demand for pediatric clinical trials.
Connor EM, Smoyer WE, Davis JM, Zajicek A, Ulrich L, Purucker M, Hirschfeld S. Connor EM, et al. Among authors: davis jm. Sci Transl Med. 2014 Mar 12;6(227):227fs11. doi: 10.1126/scitranslmed.3008043. Sci Transl Med. 2014. PMID: 24622511 Free PMC article.
2,109 results