美国、经合组织和中国GLP的特征分析与比较
Comparison on features of "Good Laboratory Practice for Nonclinical Laboratory Studies" among USA,OECD and China
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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。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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Key words:
- drug safety evaluation /
- GLP /
- USA /
- OECD
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