临床前药代动力学实验室的风险评估及安全管理  

Risk Assessment and Safety Management in Preclinical Pharmacokinetics Laboratory

作　　者：胡海红[1,2] 雷金秀 曾奎 余露山[1,2] 曾苏[1,2] HU Haihong;LEI Jinxiu;ZENG Kui;YU Lushan;ZENG Su(College of Pharmaceutical Sciences,Zhejiang University,Hangzhou 310058,China;Innovation Center of Translational Pharmacy,Jinhua Institute of Zhejiang University,Jinhua 321016,China)

机构地区：[1]浙江大学药学院,浙江杭州310058 [2]浙江大学金华研究院转化药学创制中心,浙江金华321016

出　　处：《化工管理》2024年第29期120-125,共6页Chemical Management

摘　　要：文章针对综合性实验室情况相对复杂、风险评估不准确等问题,结合临床前药代动力学实验室的具体情况,依据研究的候选药物、体外实验模型构建、体外实验操作过程、体内评价模型动物运输、饲养及实验中的生物安全等实验室风险进行评估,并对实验室建立与安全管理体系建设进行分类系统介绍,为高校或其他科研单位实验室建立及安全管理提供重要的参考。In view of the relatively complex situation and inaccurate risk assessment in comprehensive laboratories,this paper combined with the specif ic situation of preclinical pharmacokinetics laboratories,and evaluated laboratory risks based on the study of drug candidates,in vitro experimental model construction and in vitro experimental operation process,in vivo evaluation of model animal transportation,feeding and biosafety in experiments.And the laboratory establishment and safety management system construction of the classif ication system is introduced to provide an important reference for the laboratory establishment and safety management of universities or other scientif ic research institutions.

关 键 词：临床前药代动力学实验室 风险评估 安全管理 

分 类 号：R917[医药卫生—药物分析学]