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.
Abstract
摘要
相似文献
1
Regulatory science needs for neonates: a call for neonatal community collaboration and innovation.
Front Pediatr. 2014 Dec 1;2:135. doi: 10.3389/fped.2014.00135. eCollection 2014.
2
Neonatal Safety Information Reported to the FDA During Drug Development Studies.
Ther Innov Regul Sci. 2017;2017:1-9. doi: 10.1177/2168479017716713. Epub 2017 Jun 28.
3
Collaboration in Regulatory Science to Facilitate Therapeutic Development for Neonates.
Curr Pharm Des. 2017;23(38):5801-5804. doi: 10.2174/1381612823666170926114857.
4
Evaluating quality neonatal care, call Centre service, tele-health and community engagement in reducing newborn morbidity and mortality in Bungoma county, Kenya.
BMC Health Serv Res. 2018 Jun 25;18(1):493. doi: 10.1186/s12913-018-3293-5.
5
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.
Ther Innov Regul Sci. 2015 Sep;49(5):623-631. doi: 10.1177/2168479015597730.
6
Challenges and opportunities to enhance global drug development in neonates.
Curr Opin Pediatr. 2017 Apr;29(2):149-152. doi: 10.1097/MOP.0000000000000463.
8
How the Critical Path Initiative Addresses CDER's Regulatory Science Needs: Some Illustrative Examples.
Ther Innov Regul Sci. 2015 Jul;49(4):466-472. doi: 10.1177/2168479014567323.
9
Japan and its healthcare challenges and potential contribution of neonatal nurse practitioners.
J Perinat Neonatal Nurs. 2010 Apr-Jun;24(2):155-66. doi: 10.1097/JPN.0b013e3181db5363.
10
Advancing global health through regulatory science research: summary of the Global Summit on Regulatory Science Research and Innovation.
Regul Toxicol Pharmacol. 2012 Apr;62(3):471-3. doi: 10.1016/j.yrtph.2012.02.001. Epub 2012 Feb 7.
引用本文的文献
1
Antibiotics needed to treat multidrug-resistant infections in neonates.
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.
Curr Pharm Des. 2017;23(38):5801-5804. doi: 10.2174/1381612823666170926114857.
3
The Need for Pediatric Drug Development.
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.
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.
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.
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.
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.
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.
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.
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?
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.
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.
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.
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.
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.
Semin Fetal Neonatal Med. 2005 Apr;10(2):115-22. doi: 10.1016/j.siny.2004.11.003. Epub 2005 Jan 25.
Zotero 插件