药物非临床安全性评价毒性病理学评价及病理学数据分析要点

Considerations of toxicologic pathology assessment and pathological data analysis during nonclinical safety evaluation of drugs

毒性病理学是一门综合了病理学和毒理学两门学科的交叉学科,主要研究有毒物质的潜在作用。准确诊断病变和报告组织病理学检查结果将继续在药物非临床安全性评价中发挥关键作用。此外,毒性病理学评价必须结合其他相关数据进行,例如临床观察、体质量变化、临床病理学结果、以及代谢和药动学数据。简要介绍了组织病理学检查的基本要素、组织病理学的特点、组织病理学诊断注意事项、病理学数据分析和报告病理学结果的要点,以期为中国药物非临床安全性评价毒性病理学组织病理学检查及病理学数据分析提供一定参考。

Toxicologic pathology is the science that integrates the disciplines of pathology and toxicology and is concerned with the effects of potentially noxious substances.Accurate diagnosis and reporting of findings derived from histopathological examination have been and will continue to play a critical role in the nonclinical safety evaluation of drugs.In addition,the toxicologic pathology assessment must integrate other relevant data,such as clinical signs,body weight changes,clinical pathology findings,as well as metabolism and pharmacokinetic data.The paper gave a brief introduction of the fundamental elements of histopathological examination,features of the histopathology,considerations of diagnosis of histopathology,analysis of pathology data and reporting pathology findings,in order to provide some references for toxicologic pathology assessment and pathological data analysis during preclinical safety evaluation of drugs in China.