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Neonatal Safety Information Reported to the FDA During Drug Development Studies.药物研发研究期间向美国食品药品监督管理局报告的新生儿安全信息。
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Japan and its healthcare challenges and potential contribution of neonatal nurse practitioners.日本及其医疗保健挑战以及新生儿执业护士的潜在贡献。
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Advancing global health through regulatory science research: summary of the Global Summit on Regulatory Science Research and Innovation.通过监管科学研究推动全球健康：监管科学研究和创新全球峰会总结。
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Antibiotics needed to treat multidrug-resistant infections in neonates.用于治疗新生儿多重耐药感染的抗生素。
Bull World Health Organ. 2022 Dec 1;100(12):797-807. doi: 10.2471/BLT.22.288623. Epub 2022 Oct 3.
2
Collaboration in Regulatory Science to Facilitate Therapeutic Development for Neonates.监管科学合作促进新生儿治疗药物研发
Curr Pharm Des. 2017;23(38):5801-5804. doi: 10.2174/1381612823666170926114857.
3
The Need for Pediatric Drug Development.儿科药物研发的必要性。
J Pediatr. 2018 Jan;192:13-21. doi: 10.1016/j.jpeds.2017.08.011. Epub 2017 Sep 21.
4
Neonatal Safety Information Reported to the FDA During Drug Development Studies.药物研发研究期间向美国食品药品监督管理局报告的新生儿安全信息。
Ther Innov Regul Sci. 2017;2017:1-9. doi: 10.1177/2168479017716713. Epub 2017 Jun 28.
5
The International Neonatal Consortium: collaborating to advance regulatory science for neonates.国际新生儿联盟：携手推进新生儿监管科学。
Pediatr Res. 2016 Oct;80(4):462-4. doi: 10.1038/pr.2016.119. Epub 2016 Jun 8.
6
Neonatal drug therapy: The first frontier of therapeutics for children.新生儿药物治疗：儿童治疗学的首个前沿领域。
Clin Pharmacol Ther. 2015 Sep;98(3):288-97. doi: 10.1002/cpt.166. Epub 2015 Jul 22.

本文引用的文献

1
Use of opportunistic clinical data and a population pharmacokinetic model to support dosing of clindamycin for premature infants to adolescents.利用机会性临床数据和群体药代动力学模型来支持早产儿至青少年的克林霉素给药。
Clin Pharmacol Ther. 2014 Oct;96(4):429-37. doi: 10.1038/clpt.2014.134. Epub 2014 Jun 20.
2
Off-label use of drugs in children.儿童药物的标签外使用。
Pediatrics. 2014 Mar;133(3):563-7. doi: 10.1542/peds.2013-4060. Epub 2014 Feb 24.
3
Clinical trials in rare disease: challenges and opportunities.罕见病的临床试验：挑战与机遇
J Child Neurol. 2013 Sep;28(9):1142-50. doi: 10.1177/0883073813495959.
4
Strategic biomarkers for drug development in treating rare diseases and diseases in neonates and infants.治疗罕见病和新生儿及婴幼儿疾病的药物研发中的战略生物标志物。
AAPS J. 2013 Apr;15(2):447-54. doi: 10.1208/s12248-013-9452-z. Epub 2013 Jan 19.
5
What is RDS in 2012?2012年的呼吸窘迫综合征是什么？
Early Hum Dev. 2012 May;88 Suppl 2:S42-4. doi: 10.1016/S0378-3782(12)70013-0.
6
Pharmacokinetics of an elevated dosage of micafungin in premature neonates.米卡芬净高剂量在早产儿中的药代动力学。
Pediatr Infect Dis J. 2009 May;28(5):412-5. doi: 10.1097/INF.0b013e3181910e2d.
7
Surfactant-replacement therapy for respiratory distress in the preterm and term neonate.用于早产和足月新生儿呼吸窘迫的表面活性剂替代疗法。
Pediatrics. 2008 Feb;121(2):419-32. doi: 10.1542/peds.2007-3283.
8
In utero physiology: role in nutrient delivery and fetal development for calcium, phosphorus, and vitamin D.子宫内生理学：钙、磷和维生素D在营养物质输送及胎儿发育中的作用
Am J Clin Nutr. 2007 Feb;85(2):604S-607S. doi: 10.1093/ajcn/85.2.604S.
9
Patterns of drug utilization in a neonatal intensive care unit.新生儿重症监护病房的药物使用模式
J Clin Pharmacol. 2006 Apr;46(4):449-55. doi: 10.1177/0091270005285456.
10
The use of unlicensed and off-label medicines in the neonate.新生儿中未获许可药物和超说明书用药的使用情况。
Semin Fetal Neonatal Med. 2005 Apr;10(2):115-22. doi: 10.1016/j.siny.2004.11.003. Epub 2005 Jan 25.

Regulatory science needs for neonates: a call for neonatal community collaboration and innovation.

作者信息

McCune Susan K, Mulugeta Yeruk Ager

机构信息

Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration , Silver Spring, MD , USA.

Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration , Silver Spring, MD , USA ; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration , Silver Spring, MD , USA.

出版信息

Front Pediatr. 2014 Dec 1;2:135. doi: 10.3389/fped.2014.00135. eCollection 2014.

DOI:10.3389/fped.2014.00135
PMID:25520945
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4248839/
Abstract
摘要