近年来,随着我国新药创新力的不断提高,创新药物在人体内的物质平衡与转化数据,已逐步成为新药申报中不可或缺的信息。放射性同位素技术的应用,弥补了传统质谱技术的不足,有助于充分阐释药物在人体内的物质平衡及其代谢转化,故此类临床试验正日趋增加、逐步普及。笔者所在单位是全国首批开展此类项目的临床研究机构之一,至今已完成近20项同位素人体物质平衡及生物转化临床研究。笔者拟结合既往临床实践,以研究者视角,从国内外法律法规、方案设计等方面探索此类研究设计的关注点,供业界借鉴参考,以期有助于新药创制中同类试验的日后开展。
Abstract
Recently,with the rapid development of new drug research in China, the human mass balance and biotransformation (MBB) studies on innovative drugs are on a track to become indispensable during new drug application. However, traditional analysis method, e.g. mass spectrum, is insufficient to elaborately explain the mass balance and the relative biotransformation of the investigated drugs in human bodies. This problem could be solved by applying radiolabelled technique into these MBB studies, which are more and more popular nowadays. The authors′ hospital is one of the first a few organizations to conduct the MBB studies, and has completed almost 20 trials. This review mainly focused on the study design from the investigators′ viewpoints, involving the related rules and regulations, both at home and abroad, and the protocol design, so as to provide our thinkings for references and benefit to the new drug clinical trial in the future.
关键词
创新药 /
放射标记 /
临床试验 /
物质平衡与转化 /
科学性
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Key words
innovative drug /
radiolabelled /
clinical trial /
mass balance and biotransformation /
scientificity
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中图分类号:
R969.1
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脚注
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基金
国家十三五“重大新药创制”科技重大专项资助(2017ZX09304021);江苏省卫生计生委科研课题资助(G2017015);江苏省青年医学人才项目资助(QNRC2016714);苏州市科技计划项目资助(SLT201914);中华医学会临床药学分会吴阶平医学基金会专项科研基金资助(320.6750.19090-50)
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