动物病理学在新药开发风险控制中的作用

目的 进行临床前研究的主要原因在于,保证研究中新药探索实验中尤其是研发早期试验人群的安全,因为只是减少健康志愿者身上的风险无益于保证（所有）受试者的安全.内容 本文从新药研发的两个阶段分别对病理学在临床前风险控制研究中的作用进行了讨论.结论 在非临床前新药研发阶段的风险控制中,让病理学家参与到新药研发的风险管理队伍中来,帮助研发、监控研发,是成功研发与优良的风险管理策略相衔接的关键.

The Role of Animal Pathology in the Risk Control of New Drug

The principle reason for conducting pre-clinical studies is to insure the safety of human subjects in trials testing investigational drugs, particularly early in development, as there is no benefit to mitigate the risk imposed on normal volunteers. In this paper, the roles of pathology in pre-clinieal safety testing of new drugs are discussed respectively from the two phases of drug development, involving knowledgeable Pathologists within risk management teams,for assisting and monitoring drugs development,may be the key to successfully developing and articulating a well- conducted risk management strategy.