创新药人体物质平衡与代谢研究同位素示踪技术平台建设的实践与思考  

Practice and consideration on the platform construction of isotope tracer technology for human mass balance and metabolism study of new drugs

作　　者：孙鲁宁[1,2] 李天萍 周辰[1] 谢利军[1] 邵凤[1] 李建勇[1] 江骥[3] 赵俊[1] SUN Lu-ning;LI Tian-ping;ZHOU Chen;XIE Li-jun;SHAO Feng;LI Jian-yong;JIANG Ji;ZHAO Jun(First Affiliated Hospital with Nanjing Medical University,Nanjing 210029,China;School of Pharmacy,Nanjing Medical University,Nanjing 210029,China;Peking Union Medical College Hospital,Beijing 100730,China)

机构地区：[1]南京医科大学第一附属医院,南京210029 [2]南京医科大学药学院,南京210029 [3]北京协和医院,北京100730

出　　处：《中国新药杂志》2021年第17期1570-1573,共4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:呼吸病新药临床评价研究技术平台建设(2011ZX09302003-02);国家“重大新药创制”科技重大专项资助项目:创新药临床评价的同位素示踪技术平台建设(2017ZX09304032)。

摘　　要：放射性同位素示踪技术是利用放射性同位素作为示踪剂,对标记后的研究药物进行分析的方法,是国际公认人体内物质平衡、药物代谢等研究的"金标准"。国内首次[^(14)C]同位素标记创新药人体物质平衡与代谢研究在我院完成,至今同类项目共完成6项,在研多项。我院Ⅰ期临床试验研究室建立了[^(14)C]同位素标记药物临床试验流程和标准操作规程(SOP),并探索建设同位素示踪技术平台服务于创新药临床评价。本文介绍了平台运行的重点内容,包括试验设计思考、立项与伦理审查、受试者管理、试验药物管理、生物样本管理、试验环境管理、研究者与项目培训等主要环节,为同位素示踪技术在创新药临床研究中的应用提供参考。Radioisotope tracer technology,as a method to analyze labeled drugs using radioisotopes as tracers,is internationally recognized as the"gold standard"in human mass balance and metabolism study.The first[^(14)C]-radiolabeled drug clinical trial regarding human radiolabeled mass balance and metabolism study was completed in Phase I clinical trial unit of our hospital.Up to now,we have completed six trials,and several trials are in progress.The Standard Operating Procedures for clinical trial of[^(14)C]-radiolabeled drug have been established,and the construction of isotope tracer technology platform for new drug clinical trails in human have been explored.This paper introduces the key points of technology platform operation,such as protocol design and consideration,project establishment and ethical review,management of subjects,study drug,biological sample,and environment,requirement of investigator,project training and other contents.The objective of this paper is to provide information for the application of isotope labeling technique in mass balance,metabolism and other clinical trials of innovative drugs.

关 键 词：放射性同位素标记 同位素示踪技术平台 物质平衡与代谢研究 新药临床试验 

分 类 号：R969.1[医药卫生—药理学]