期刊文献+

探讨国内现状对接受国外儿科临床试验数据的影响

Discussion about effects of current situation in China on the acceptance of foreign data in worldwide pediatric clinical trials
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摘要 分析目前全球开展儿科临床研究的现状,提出接受国外儿科临床研究数据,应从全球研究结果、亚裔人群结果、可能导致临床药理学差异的因素到各国医疗实践的差异等方面加以考虑,要建立以科学为基础的分析思路,这将有助于鼓励我国儿科临床研究并避免不必要的重复研究。 Analyzing current situation in worldwide pediatric clinical trials, consideration should be covered as such issues below, including globe data, subpopulation data of Asia, affect factors in clinical pharmacology and medical practice when foreign data are accepted. The clear thinking is science based, it will be helpful to encourage conducting clinical trials in children and avoid unnecessary trials.
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2010年第5期323-325,共3页 The Chinese Journal of Clinical Pharmacology
关键词 临床试验 儿科患者 儿童 clinical trial pediatric population children
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参考文献3

  • 1ICH E11.Clinical investigation of medicinal products in the pediatric population[EB/OL],http;//www.fda.gov/RegulatoryInformation/ Guidances/ucm129476.htm,2000 -11.
  • 2NIH.Map of 2836 studies found by search of; pediatric trials[EB/ OL].Http://www.Clinicaltrials.Gov/ct2/results/map? Term = pediatric + trials,2010-03-01.
  • 3Myrand SP,Sekiguchi K,Man MZ,et al.Pharmacokinetica/genotype associations for major cytochrome P450 enzymes in native and first -and third-generation Japanese populations:comparion with Korean,Chinese,and Caucasion populations[J].Clin Pharmacol Ther,2008; 84:347-361.

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