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An overview of nonclinical study and evaluation of diagnostic radiopharmaceuticals approved for marketing in the United States in the last two decades
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Ai-fang LI, Hong-mei GUANG, Qing-li WANG
Chinese Journal of New Drugs | 2021, 30(10) : 865 - 870
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收藏切换
Chinese Journal of New Drugs | 2021, 30(10): 865-870
An overview of nonclinical study and evaluation of diagnostic radiopharmaceuticals approved for marketing in the United States in the last two decades
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Ai-fang LI, Hong-mei GUANG, Qing-li WANG
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Published: 2021-05-30
Outline
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In recent years, with the development of radiochemistry, nuclear medicine and molecular biology technology and the interdisciplinary integration, diagnostic radiopharmaceuticals have become a hot field of drug research and development at home and abroad. In the past two decades, the US FDA has approved a number of new diagnostic radiopharmaceuticals for the diagnosis of tumor, cardiovascular disease, Parkinson's syndrome and other diseases. The nonclinical study of drugs is a key part of drug development. This paper sorted out the nonclinical study information of FDA-approved diagnostic radiopharmaceuticals and summarized the focus of nonclinical study and evaluation, aiming to provide information for such drugs' development in China.

diagnostic radiopharmaceuticals  /  FDA  /  nonclinical study and evaluation
李艾芳, 光红梅, 王庆利. 美国近20年批准上市的放射性诊断药物的非临床研究评价概述. 中国新药杂志, 2021 , 30 (10) : 865 -870 .
Ai-fang LI, Hong-mei GUANG, Qing-li WANG. An overview of nonclinical study and evaluation of diagnostic radiopharmaceuticals approved for marketing in the United States in the last two decades[J]. Chinese Journal of New Drugs, 2021 , 30 (10) : 865 -870 .
Year 2021 volume 30 Issue 10
27
8
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  • Online Date:2026-10-28
  • Published:2021-05-30
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  • Accepted:2020-12-29
Affiliations
    Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
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表12种不同金属材料的力学参数
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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