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AbstractIn recent years, the global radiopharmaceutical industry has exhibited a marked trend of rapid growth, playing a pivotal role in the precise diagnosis and treatment of diseases such as oncology, cardiovascular disorders, and neurological conditons, and thus holding extensive application prospects. With the further advancement of precision medicine, clinical trials of radiopharmaceuticals have been increasingly conducted, providing critical evidence for the market approval of more innovative nuclear drugs. However, the quality management of radiopharmaceutical clinical trials present distinct priorities and challenges compared with that of general clinical trials. For example, the short half-life of radionuclides necessitates that investigational radiopharmaceuticals strict adherence to the time window for preparation, quality control, transportation, and administration-any delay at any step may compromise the reliability of trial outcomes. Additionally, radiopharmaceuticals involve unique considerations such as radiation safety, waste disposal, and accurate dose measurement, which impose higher requirements on personnel qualifications, storage and use management of nuclear drugs, radiation protection for participants and healthcare professionals, data traceability, and regulatory compliance. This paper reviews the development of nuclear drug clinical trials and the specific cases of radiopharmaceutical clinical trials conducted at our institution, and summarizes the key points and difficulties in quality control-covering personnel qualifications, nuclear drug management, safety protection, and data management-with the aim of providing useful references for the quality management of nuclear drug clinical trials at various clinical trial institutions.
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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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