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[摘要]
围绕药品非临床研究质量管理规范(GLP)体系下生殖发育毒性评价所使用仪器确认展开讨论,提供开展仪器确认所需要的关键事项:根据研究目的,选取合适种属的实验动物;动物数量应满足统计学需求;准确选取实验受试物,购入标准品或阳性药物;确定实用性强、干扰因素少的确认方法;把握实验关键点、排除其他因素对确认的干扰;建立准确度高可重现性好的评价标准;根据实验室基本情况以及研究目的,在标准作业程序(SOP)中规定不同仪器确认所需要的周期。现有生殖毒性仪器确认规范性、标准化成为实验室管理的新难点,需要努力推进其标准化规范化进程。
[Key word]
[Abstract]
This paper focused on how to successfully carry out equipment qualification of nonclinical reproductive toxicity study on drugs. The following issues are principally argued. Select the appropriate species of laboratory animal; Animal number should meet the statistical requirements; Accurate selection of experimental subjects; Determine the practicability and less interference verification method; Grasp the key points and the exclusion of other factors interference to verify accuracy; A high reproducibility of the evaluation criteria; According to the basic situation of laboratory and research, regulate the cycle of different instrument validation required in SOP. The evaluation system still have some disadvantages, and the reliability of performance has become a new problem of laboratory management.
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