Progress in Development of Human Radiolabelled Mass Balance and Biotransformation Studies
MA Sheng1,2, YI Ling1, MIAO Li-yan1,2*
1. National Institution of Drug Clinical Trial, First Affiliated Hospital of Soochow University, Suzhou 215031, China; 2. Institute for Interdisciplinary Drug Research and Translational Sciences, College of Pharmaceutical Sciences, Soochow University,Suzhou 215031, China
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.
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MA Sheng, YI Ling, MIAO Li-yan. Progress in Development of Human Radiolabelled Mass Balance and Biotransformation Studies. Chinese Pharmaceutical Journal, 2020, 55(14): 1184-1188.
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