论文部分内容阅读
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。
Discuss the equipment used in the assessment of reproductive and developmental toxicity under the Non-Clinical Study Quality Management Practices (GLP) system and provide the key points needed for instrument validation. Select the appropriate animal species according to the purpose of the study. The number of animals should meet Statistical requirements; Accurately selected experimental test substance, purchased standard or positive drug; Confirmed the practicality of the confirmation method with fewer interference factors; Grasp the key points of the experiment to exclude the interference of other factors on the confirmation; Establish a highly accurate Good current evaluation criteria; according to the laboratory basic conditions and research purposes, in the standard operating procedures (SOP) provides different instruments to confirm the required cycle. Existing reproductive toxicity of the instrument to confirm normative, laboratory management has become a new difficulty, we must strive to promote its standardization process.