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Flow cytometry (FCM), due to its high-throughput, multi-parametric and precise analytical capabilities, has become an indispensable tool in clinical research, diagnosis and treatment monitoring. In recent years, with the rapid development of new biotechnologies and emerging cell and gene therapy drugs, the importance of some key endpoints measured by flow cytometry in registered clinical studies has become even more prominent. Therefore, an expert consensus and best practice of the flow cytometry validation in the industry is urgently needed. The method validation of flow cytometry is to ensure reliable, accurate and reproducible results in scientific research and clinical applications. The validation process demonstrates the suitability of the method under specific application scenarios and experimental requirements by evaluating multiple performance parameters. Based on the complexity and diversity of flow cytometry and the current situation where there are many problems and challenges faced in clinical trials, the Bioanalysis Expert Committee of the Chinese Pharmaceutical Association has organized industry experts to reach a consensus and standards on aspects such as the method development and validation of immunophenotyping, receptor occupancy and pharmacokinetics of cell therapies in clinical studies by flow cytometry, aiming to provide recommendations and references for the scientific and standardized conduct of such studies.
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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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