Full
Outline
Phase Ⅰ clinical trial is a preliminary clinical pharmacology and safety evaluation trial in human body to observe human tolerance to new drugs and its pharmacokinetics, providing basis for the drug administration strategy. The subjects are mainly healthy volunteers. Phase Ⅰ clinical trials are usually non-therapeutic, thus whether the drug can be successfully administered is the key of the trial. Oral administration is the most commonly used and the easiest way for administration in phase Ⅰ clinical trials; however, it is usually overlooked due to the most facility when application. To prevent errors in administration and ensure effective, smooth and correct administration, this article discusses how to deal with the risk of oral medicine, take measures, formulate the response system, and then to strengthen the management of oral administration, in order to effectively control the risk of oral medicine and guarantee the success through subject, researcher, drug administrator, quality control personnel before, during and after the drug administration.
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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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