[关键词]
[摘要]
药物安全性评价中毒性病理学评价是最重要的一个步骤,而毒性病理学评价作为药物安全性评价体系中重要的一环,用以确定损伤靶器官、靶组织的形态及程度变化,评价受试药物是否具有毒性并判断其能否推向临床的重要指标。对组织学技术进行质量控制与评估则是确保毒性病理诊断准确性及一致性的重要前提。该文对组织学技术流程进行叙述并探讨流程中相关影响因素。
[Key word]
[Abstract]
The evaluation of toxicological pathology is the most important step in the evaluation of drug safety, which is an important part of system in drug safety evaluation. It is used to identify the changes in morphology and degree of target organs and target tissues, to evaluate whether the drugs are toxic and judge they can be enter the clinic or not. The quality control and evaluation of histological techniques is an important prerequisite to ensure the accuracy and consistency of the diagnosis of toxicological pathology. This paper describes the process of histological techniques and discusses the related factors in the process.
[中图分类号]
[基金项目]
国家科技重大新药创制项目(2015ZX09501004);天津市科技计划项目(16PTGCCX00090)