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Novel drug research and development has high failure rate and “a narrow escape from death”, which needs to strike a balance between rapid progress, development risk and cost reduction and scientific decision-making, it is necessary to achieve "two early": eliminate drugs that may fail as early as possible with little investment, obtain key evidence as early as possible to enhance confidence in subsequent research and development, which is also known as "Quick win, fast fail" concept. Phase 0 clinical trial, as an early exploratory research tool, has the characteristics of low dose, short cycle, small number of subjects, and flexible application requirements. It is mainly used to rapidly evaluate the potential of drug candidates for further development, and more efficiently screen and develop potential drug candidates. The Phase 0 clinical trial strategy requires a variety of specific technologies and qualified personnel, including radiopharmaceutical labeling techniques, high-sensitivity analysis techniques, imaging techniques, pharmacokinetic and pharmacodynamic modeling, ethical review and subject recruitment, as well as multidisciplinary team collaboration and highly specialized research institutions. The effective integration and collaboration of these technologies and personnel is the key to the success of Phase 0 clinical trial. This paper mainly introduces the benefit-risk assessment strategy, required technologies, application requirements, and case analysis of the new paradigm for novel drug development incorporating phase 0 clinical trial.
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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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