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Paediatric prescribing: using unlicensed drugs and medicines outside their licensed indications.

作者信息

Collier J

出版信息

Br J Clin Pharmacol. 1999 Jul;48(1):5-8. doi: 10.1046/j.1365-2125.1999.00983.x.

DOI:10.1046/j.1365-2125.1999.00983.x
PMID:10383552
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2014867/
Abstract
摘要

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本文引用的文献

1
Status of new medicines approved by the European Medicines Evaluation Agency regarding paediatric use.欧洲药品评估局批准的新药儿科用药情况。
Br J Clin Pharmacol. 1999 Jul;48(1):15-8. doi: 10.1046/j.1365-2125.1999.00981.x.
2
Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients--FDA. Final rule.要求制造商评估新药和生物制品在儿科患者中的安全性和有效性的法规——美国食品药品监督管理局。最终规则。
Fed Regist. 1998 Dec 2;63(231):66631-72.
3
Unlicensed and off label drug use in neonates.新生儿使用未经许可和超说明书用药情况。
Arch Dis Child Fetal Neonatal Ed. 1999 Mar;80(2):F142-4; discussion F144-5. doi: 10.1136/fn.80.2.f142.
4
Unlicensed and off label drug use in paediatric wards: prospective study.儿科病房中未获许可及超说明书用药情况:前瞻性研究
BMJ. 1998 Jan 31;316(7128):343-5. doi: 10.1136/bmj.316.7128.343.
5
Use of "off-label" and unlicensed drugs in paediatric intensive care unit.
Lancet. 1996 Feb 24;347(9000):549-50.
6
Prescribing unlicensed drugs or using drugs for unlicensed indications.开具未经许可的药物或使用药物用于未经许可的适应症。
Drug Ther Bull. 1992 Dec 7;30(25):97-9.