Full
Outline
The aim of bio-distribution study is to investigate the performance of medicine reaching the target organs after it was administrated to the human body, as well as its metabolism and clearance process with the time extending. Bio-distribution is a particular and feature research area specific for gene therapy medicines. It could lead severe hazards when human body exposing exogenous gene segments, thus it's necessary to adopt appropriate methods to monitor the state of gene segments of medicines inside the human body to predict potential safety risks. Currently, many regulatory authorities request to carry out bio-distribution research in preclinical study and provide relevant data and information before application in clinical trials. This article mainly generalizes the testing items, types and features of samples, analytical methods and detective strategy of bio-distribution study to provide the industry and regulatory agency with detailed and practical guidance for these kinds of researches and consequently prompt the regulation science in China in the field of preclinical evaluation and assessment.
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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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