Application progress of radiolabeled drugs in new drug research and development in China
10.16438/j.0513-4870.2022-1061
- VernacularTitle:放射性标记药物在我国新药研发中的应用进展
- Author:
Xing-xing DIAO
;
Jing-hua YU
;
Da-fang ZHONG
- Publication Type:Research Article
- Keywords:
radiolabeled drug;
rug metabolism;
mass balance;
rug research and development
- From:
Acta Pharmaceutica Sinica
2023;58(2):313-319
- CountryChina
- Language:Chinese
-
Abstract:
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.
