摘要
目的:阐述药物非临床安全性评价机构毒理学试验中解剖病理学质量控制的重要性及要点,为提高我国非临床安全性评价机构解剖病理学质量控制提供参考。方法:对药物非临床安全性评价机构病理部门的组织和管理、标准操作规程、解剖病理学检查、病理学报告书写、组织病理学检查的质量控制要点及注意事项进行逐条梳理。结果:解剖病理学质量控制可确保病理学数据真实、准确、完整和可靠,还可为确定受试物的靶器官、有害作用以及作用机制提供可靠的病理学数据支持。结论:毒性病理学是药物非临床安全性评价机构毒理学试验的重要组成部分,毒理学试验解剖病理学的质量控制非常重要,应该给予高度重视。
Objective:To elaborate the importance and key points of quality control for anatomical pathology of toxicological studies,so as to provide references for improving the quality control for anatomical pathology in facilities for nonclinical safety evaluation of drugs in China.Methods:The organization and management,Standard Operating Procedures(SOPs),anatomical pathology examination,pathology report preparation,and the key points of quality control in histopathology examination of the pathology division in facilities for nonclinical safety evaluation of drugs are reviewed one by one.Results:Quality control for anatomical pathology of toxicological studies could ensure the authenticity,accuracy,completeness and reliability of pathological data,and provide reliable data support for determining the target organs,adverse effects and mechanism of action of the test articles.Conclusion:Toxicological pathology is an important part of the toxicological studies in facilities for nonclinical safety evaluation of drugs.The quality control for anatomical pathology in toxicological studies is very important and should be given high priority.
作者
霍桂桃
杨艳伟
屈哲
林志
张頔
吕建军
Huo Guitao;Yang Yanwei;Qu Zhe;Lin Zhi;Zhang Di;Lu Jianjun(National Center for Safety Evaluation of Drugs,National Institutes for Food and Drug Control,Beijing Key Laboratory for Safety Evaluation of Drugs,Beijing 100176,China)
出处
《中国药事》
CAS
2020年第7期790-798,共9页
Chinese Pharmaceutical Affairs
基金
十三五重大新药创制专项课题“创新药物非临床安全性评价研究关键技术”(编号2018ZX09201017)。
关键词
非临床安全性评价
毒理学
解剖病理学
质量控制
有害作用
nonclinical safety evaluation
toxicology
anatomical pathology
quality control
adverse effect
