Full
Outline
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.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 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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