GLP药物安全性评价中毒性病理学存在的问题及对策

毒性病理学是药物临床前安全性评价的基石，但在实际工作中，病理检验存在诊断标准不统一、操作规程不实际、实验动物病理基础研究薄弱等诸多问题，严重地威胁GLP的运行和成效。因此，毒性病理工作应在实施病理诊断的标准化和推进实验室认证认可的同时，加强实验动物比较组织学和比较病理学研究，建立毒性病理数据库，从根本上促进药物安全性评价水平的提高。

The Existing Problem and Countermeasure of Toxicity Pathology in GLP Medicine Safety Evaluation

Toxicity pathology is the footstone of medicine preclinical safety evaluation. In practice, many problems were exist in pathological examination such as criterion were discordance, operating procedure was nonstandard and labanimal pathology study was unsubstantially, which severely threaten the running and effect of GLP. Therefore, toxicity pathology laboratory should execute the standardization of examination and promote laboratory certification and accreditation. It also was very important that strengthening research of comparative histology and comparative pathology in labanimal and building toxicity pathology database. All of this was to fundamentally accelerate the level of medicine safety evaluation.