摘要
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。
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.
出处
《中国比较医学杂志》
CAS
2007年第1期51-54,共4页
Chinese Journal of Comparative Medicine
基金
广东省重点科技项目(99B07901Q)新药非临床安全评价中心(GLP)
