药物毒代动力学的研究现状与展望  

Status and prospects in drug toxicokinetics

作　　者：于敏[1] 李佐刚[1] 

机构地区：[1]中国食品药品检定研究院国家药物安全评价监测中心药物代谢动力学室,北京100176

出　　处：《中国新药杂志》2017年第7期742-748,共7页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项资助项目"生物大分子药物特殊评价关键技术研究"(2015ZX09501007-004)

摘　　要：毒代动力学作为药动学和毒理学的交叉学科,现已成为药物非临床研究的重要内容,是临床前研究推进至临床研究的桥梁和工具。本文综述了现阶段国内毒代动力学研究的基本内容,着重介绍了毒代动力学研究的指导原则、实验设计各个方面的注意事项、生物分析方法、动力学参数和毒代动力学研究在临床前安全性评价中的应用、小分子药物和大分子药物存在的差别,以及国外毒代动力学研究的进展。Toxicokinetics（ TK） is pharmacokinetics applied to high doses used in toxicity testing of drugs,and now become an important study of non-clinic research in drug discovery and development. TK data can contribute to the assessment of the adequacy and relevance of animal toxicity data for extrapolation to human hazard and/or risk assessment. By retrieving guidances and publications,all guiding principles,practical considerations in study protocols,bioanalytical method and application,TK parameters,toxicokinetics in the various areas of toxicity testing and difference of the TK behavior of small and large molecules were described in detail. Situations and prospects of toxicokinetics study in the domestic and overseas were simply outlined.

关 键 词：毒代动力学 非临床 药物安全性评价 药动学 

分 类 号：R992[医药卫生—毒理学]