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With China's accession to ICH and implementing a series of ICH guidelines, the pharmaceutical innovation system of China has been in line with international standards and deeply integrated into the global innovation system, making overseas declaration data can be used in China's new drug marketing application. The ability of global synchronous investigation and registration has been largely improved along with these development. Clinical trials gradually need to involve healthy foreign subjects, especially those who need to be compared in the pharmacokinetic characteristics of different races in order to bridge the existing data abroad. What are the similarities and differences between the management process of clinical research on healthy foreign subjects and their Chinese counterparts? What factors should be paid attention to? This article takes a phase I clinical trial involving Caucasian subjects as an example to share and discuss the implementation and management experience of clinical studies involving foreign subjects to answer these questions.
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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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