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Application progress of radiolabeled drugs in new drug research and development in China
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Xing-xing DIAO*, Jing-hua YU, Da-fang ZHONG*
Acta Pharmaceutica Sinica | 2023, 58(2) : 313 - 319
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Acta Pharmaceutica Sinica | 2023, 58(2): 313-319
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Application progress of radiolabeled drugs in new drug research and development in China
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Xing-xing DIAO*, Jing-hua YU, Da-fang ZHONG*
Affiliations
  • Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China
Published: 2023-02-12 doi: 10.16438/j.0513-4870.2022-1061
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The metabolism study of radiolabeled drugs plays an important role in the development of new drugs. It provides information on drug absorption, metabolism, tissue distribution and excretion, and plays an irreplaceable role in the metabolite safety evaluation and mass balance of new drugs. The new guidance draft on clinical trials of radiolabeled drugs recently released by the US FDA puts forward higher standards and has been widely concerned by the industry. In recent years, in the research and development of new drugs in China, 14C labeled drugs have been used to carry out clinical metabolism studies, which has overcome key technical bottlenecks and accumulated experience. This paper summarizes the above research progress, analyzes the existing problems, and preliminarily looks forward to the future technological development and application.

radiolabeled drug  /  drug metabolism  /  mass balance  /  drug research and development
Xing-xing DIAO, Jing-hua YU, Da-fang ZHONG. Application progress of radiolabeled drugs in new drug research and development in China[J]. Acta Pharmaceutica Sinica, 2023 , 58 (2) : 313 -319 . DOI: 10.16438/j.0513-4870.2022-1061
Year 2023 volume 58 Issue 2
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doi: 10.16438/j.0513-4870.2022-1061
  • Receive Date:2022-09-16
  • Online Date:2025-11-21
  • Published:2023-02-12
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  • Received:2022-09-16
  • Revised:2022-11-29
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    Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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Genus
种数
Number of
species
占总种数比例
Percentage of total
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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