[1]李正奇△,徐洪德,韩忠泽.中国与韩国药物非临床研究质量管理规范的比较[J].郑州大学学报(医学版),2011,(05):719-79.
 LI Zhengqi,XU Hongde,HAN Zhongze.Comparison of Good Labovatory praetice between China and Korea[J].JOURNAL OF ZHENGZHOU UNIVERSITY(MEDICAL SCIENCES),2011,(05):719-79.
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中国与韩国药物非临床研究质量管理规范的比较
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《郑州大学学报(医学版)》[ISSN:1671-6825/CN:41-1340/R]

卷:
期数:
2011年05期
页码:
719-79
栏目:
论著
出版日期:
2011-09-20

文章信息/Info

Title:
Comparison of Good Labovatory praetice between China and Korea
作者:
李正奇1徐洪德2韩忠泽3
1)国家食品药品监督管理局药品认证管理中心 北京 100061 2)郑州大学药学院 郑州 450001 3)Chemon非临床评价研究中心 韩国 京畿道
Author(s):
LI Zhengqi1 XU Hongde2 HAN Zhongze3
1)Center for Certification of Drug,State Food and Drug Administration, Beijing 100061 2)School of Pharmaceutical Sciences,Zhengzhou University,Zhengzhou 450001 3)Preclinical Research Center, Chemon Inc., Gyeonggido, Korea
关键词:
中国韩国药物非临床研究质量管理规范
Keywords:
ChinaKoreagood laboratory practice
分类号:
R1
摘要:
目的:寻找中国与韩国药物非临床研究质量管理规范(GLP)的共同点和差异,比较各方GLP的优势,提出发展和完善我国GLP的建议。方法:采用文献法及比较法,结合我国GLP现状,详细分析两国GLP的内容和发展现状。结果:两国GLP整体内容基本一致,特别在实验设施及仪器管理、供试品及对照物、标准操作规程等方面相差不大,但在管理体系、定义及解析、组织机构和人员、工作人员理念及GLP认证检查等方面有差异。结论:我国GLP机构有必要导入毒性试验管理软件及多地点试验概念,并需要加强动物伦理及保护方面的措施。
Abstract:
Aim: To find the common points and differences of the good laboratory practice (GLP) between China and Korea, and to compare the advantages of each GLP, the suggestions to develop and perfect the GLP in China were raised.Methods:This study uses literature and comparison method, and the present developmental situation of GLP between two countries were analyzed in detail combined with the current situation of GLP in China.Results:GLP issued by SFDA and KFDA were basically consistent in general structure and topics, especially in the aspect of lab facility, equipment management, SOP,test and control articles. However, some differences were existed with regard to management system, definition and analysis, organization and personnel, testing protocol,report and GLP inspection.Conclusion:It is necessary to introduce the management software of toxic studies and the concept of multisite studies for institution of GLP in China, and to strengthen the measures in the aspect of animal rights and animal welfare.

参考文献/References:

[1]药物非临床研究质量管理规范[S].国家食品药品监督管理局令第2号.2003
[2]李波.药物非临床研究质量管理规范(GLP)概述[J].中国药师,2007,10(1):36
[3]万红平,焦岫卿.OECD“GLP原则”与中国“GLP规范”的比较[J].中国药事, 2006,20(5):259
[4]刘夏,叶桦.美国、经合组织和中国GLP的特征分析与比较[J].药学实践杂志,2008,26(5):372
[5]杨永珍.国内外良好实验室规范(GLP)和GLP 资料国际互认的概况[C]//农业部农药检定所.第七届中国农药发展年会家药质量与安全文集.成都,2005
[6]宫岩华,李茂忠.日本和韩国GLP考察报告[J].中国药品监管,2004(2):57

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备注/Memo

备注/Memo:
△男,1965年4月生,硕士,主任药师,研究方向:GCP与GLP监管,Email:sfdaccd@163.com
更新日期/Last Update: 2011-09-20