【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[¹⁴C]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[¹⁴C]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。更多还原

【Abstract】 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 [¹⁴C]-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 [¹⁴C]-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.更多还原