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儿科药物临床试验的发展历史及研究现状 被引量:17

A Brief Review of History and Current Status of Pediatric Clinical Trials
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出处 《儿科药学杂志》 CAS 2010年第2期4-7,共4页 Journal of Pediatric Pharmacy
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参考文献24

  • 1Steinbrook R. Health policy report [ J]. New England Journal of Medicine, 2002, 347: 1462-1470.
  • 2Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook [ M]. 12th Edition, Lexi- Comp: 4-5.
  • 3Caldwell PHY, Murphy SB, Butow PN, et al. Clinical trials in children [J]. Lancet, 2004, 364: 803-811.
  • 4Impicciatore P, Choonara I, Clarkson A, et al. Incidence of adverse drug reactions in paediatric in/out-patients : a systematic review an meta-analysis of prospective studies [ J]. Br J Clin Pharmacol, 2001, 52: 77-83.
  • 5Buck ML. The FDA Modernization Act of 1997: impact on pediatric medicine [ J]. Pediatric Pharmacotherapy, 2000, 6: 12.
  • 6Cohen SN. The pediatric pharmacology research unit (PPRU) network and its role in meeting pediatric labeling needs [ J ]. Ediatrics, 1999, 104: 644-645.
  • 7郑晓红(摘).欧盟儿童用药监督管理条例开始生效[J].国外药讯,2007(10):4-5. 被引量:3
  • 8郑晶心(摘).英国建立儿童临床试验网络[J].国外药讯,2005(9):3-3. 被引量:1
  • 9陆颖(摘).IFPMA建立儿科临床试验数据库[J].国外药讯,2008(11):37-37. 被引量:1
  • 10Wang L, Zao DY, Zhang ZH. Trial of antiepilepsirine (AES) in children with epilepsy [ J ]. Brain and Development, 1999, 21: 36-40.

二级参考文献15

  • 1Paul IM. Advances in pediatric pharmacology, therapeutics, and toxicology [J]. Adv Pediatr, 2005, 52: 321-365.
  • 2Choonara I. Regulation of drugs for children in Europe [ J ]. BMJ, 2007, 335(7632) : 1221-1222.
  • 3Li Wang, R Vieth, RC Landes, et al. Antiepileptie effect of antiepilepsirine in pentylentetrazol and amygdala kindled rats [J]. Epilepsy Research, 1993, 15: 1-5.
  • 4Li Wang, Dayao Zao, Zonghao Zhang, et al. Trial of antiepilepsirine (AES) in children with epilepsy [J]. Brain & Development, 1999, 21: 36-40.
  • 5MacLeod S, Peterson R, Wang Y, et al. Challenges in international pediatric pharmacology: a milestone meeting in Shanghai [J]. Pediatr Drugs, 2007, 9(4): 215-218.
  • 6Shirkey HC.Drug Dosage for Infants and Children[].The Journal of The American Medical Association.1965
  • 7Radde IC,MacLeod SM.Pediatric pharmacology&therapeutics[]..1993
  • 8Department of Health and Human Services,Food and Drug Administration.Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Final Rule:21CFR Parts201,312,314,601.Docket No.97N-0165 .
  • 9Carol K Taketomo,Jane H Hodding,Donna M Kraus.Pediatric Dosage Handbook[]..
  • 10Thomas J Moore,Sheila R Weiss,Sigal Kaplan,et al.Reported Adverse Drug Events in Infants and Children Under2Years of Age[].Pediatrics.2002

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