Full
Outline
Phase Ⅰ clinical trial is the most important course in the clinical stage of new drug discovery and development. The accuracy, authenticity, and traceability of clinical data in each step are of crucial importance. The administration of injectable medicines in phase Ⅰ clinical trial is different from routine practice, and its particularity requires researchers to control all the details related to medicines more accurately, which include accurate calculation and dispensing of dosage, accurate infusion speed and observation, calculation of actual dosage, etc. We have completed several phase Ⅰ clinical trials of injectable drugs. This paper summarized our experience in each aspect above-mentioned. This not only provides experience for the implementation of injectable medicine clinical trials, but also fully help protect the safety of subjects and ensures the quality of clinical trials.
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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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