| 美国、经合组织和中国GLP的特征分析与比较 |
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| 引用本文： | 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):372-375. |
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| 作者姓名： | 刘夏 叶桦 |
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| 作者单位： | 复旦大学药学院药事管理教研室,上海,200032 |
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| 摘 要： | 通过对美国、国际经济合作与发展组织(OECD)和我国三方的GLP(原则),以及产生、发展和现状进行对照和研究,试图寻找各方GLP(原则)的共同点和差异,比较各方GLP(原则)的优势.结合我国GLP现状,提出发展和完善GLP的建议,即:实施GLP需要完善的法律和监管体系;应当充分发挥质量保证部门(QAU)的作用;并且构建实验数据的电子采集系统.GLP建设是一个动态的过程.
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| 关 键 词： | 药物安全性评价 美国 |
| 收稿时间： | 2007/9/12 0:00:00 |
Comparison on features of "Good Laboratory Practice for Nonclinical Laboratory Studies" among USA,OECD and China |
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| LIU Xia and YE Hua.Comparison on features of "Good Laboratory Practice for Nonclinical Laboratory Studies" among USA,OECD and China[J].The Journal of Pharmaceutical Practice,2008,26(5):372-375. |
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| Authors: | LIU Xia and YE Hua |
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| Institution: | School of Pharmacy,Fudan University,Shanghai 200032,China;School of Pharmacy,Fudan University,Shanghai 200032,China |
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| Abstract: | According to the comparison on the items in three GLP(/or Principle)formed by USA,OECD and China,respective- ly,and on their foundation,history and current status,the advantages of each GLP(/or Principle)have been studied.Some advices are presented,which are actualizing GLP needs consummate law and supervise system;making the full use of QAU;establishing the e- lectric collection system of test data.It is also a developing course. |
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| Keywords: | GLP OECD |
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