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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: mccune sk. Ther Innov Regul Sci. 2015 Sep;49(5):623-631. doi: 10.1177/2168479015597730. Ther Innov Regul Sci. 2015. PMID: 30227031
Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA.
Green DJ, Burnham JM, Schuette P, Liu XI, Maas BM, Yao L, McCune SK, Chen J, van den Anker JN, Burckart GJ. Green DJ, et al. J Clin Pharmacol. 2018 Jul;58(7):885-890. doi: 10.1002/jcph.1109. Epub 2018 Apr 17. J Clin Pharmacol. 2018. PMID: 29663424 Free PMC article.
Surrogate Endpoints in Pediatric Studies Submitted to the US FDA.
Green DJ, Sun H, Burnham J, Liu XI, van den Anker J, Temeck J, Yao L, McCune SK, Burckart GJ. Green DJ, et al. Clin Pharmacol Ther. 2019 Mar;105(3):555-557. doi: 10.1002/cpt.1117. Epub 2018 Aug 9. Clin Pharmacol Ther. 2019. PMID: 30094815 Free PMC article. Review.
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. Among authors: mccune s. 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.
225 results