摘要
毒性病理学是从形态学的角度阐明药物毒性造成的组织损伤,包括药物损伤类型、作用部位、病变程度和预后等基本问题,为临床前药物安全性评价研究提供客观准确的数据支持。因此,毒性病理学在药物安全性评价中具有重要作用,其数据或结论常常决定了许多药物研发项目的终止或继续。从毒性病理学的特点、规范性管理、病理学新技术的发展(包括原位杂交、激光扫描细胞技术、激光捕获显微切割等),以及毒性病理学发展面临的问题等方面进行了简要论述。
Toxicological pathology is a morphological elucidatet ion of tissue damage caused by drug toxicity,including damage type,location,severity grade and prognosis.It provides objective and accurate data to support preclinical drug safety evaluation.Therefore,toxicological pathology plays an important role in drug safety evaluation,and the pathologic data or conclusion often determines the termination or continuation in many drug development projects.In this paper,the characteristic of toxicological pathology,standardized management,the development of new techniques including in situ hybridization,laser scanning cytometry and laser capture microdissection,and related problems in pathology are discussed briefly.
出处
《药物评价研究》
CAS
2017年第4期450-454,共5页
Drug Evaluation Research
基金
国家科技重大专项(2015ZX09501007-004)
重大新药创制(2015ZX09501004-002)
关键词
毒性病理学
药物毒性
药物安全性评价
规范性管理
病理技术
toxicological pathology
drug toxicity
drug safety evaluation
standardized management
pathologic technique
