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Novel designs for early clinical trials of anticancer drugs
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Ruo-bing LI1, Juan HE2, Fang-rong YAN2, Jian-hong PAN1
Chinese Journal of New Drugs | 2021, 30(24) : 2249 - 2255
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Chinese Journal of New Drugs | 2021, 30(24): 2249-2255
Novel designs for early clinical trials of anticancer drugs
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Ruo-bing LI1, Juan HE2, Fang-rong YAN2, Jian-hong PAN1
Affiliations
  • 1Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
  • 2State Key Laboratory of Natural Medicine, Research Center of Biostatistics and Computational Pharmacy, China Pharmaceutical University, Nanjing 210009, China
Published: 2021-12-30
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Novel designs for early clinical trials of anticancer drugs have received widespread attention and have been applied in drug development. This paper introduced three methods, i.e., algorithm-based designs, model-based designs and model-assisted designs, in single-dose exploration and multiple-dose exploration respectively. Their basic ideas and statistical methods were introduced and then their strengths and weaknesses were explained. These novel designs can not only reduce R&D costs and research time but also determine whether the medicine is effective in clinic earlier, thereby increasing the development efficiency.

anticancer drugs  /  algorithm-based design  /  model-based design  /  model-assisted design
李若冰, 何娟, 言方荣, 潘建红. 抗肿瘤药物早期临床研究的新颖试验设计方法. 中国新药杂志, 2021 , 30 (24) : 2249 -2255 .
Ruo-bing LI, Juan HE, Fang-rong YAN, Jian-hong PAN. Novel designs for early clinical trials of anticancer drugs[J]. Chinese Journal of New Drugs, 2021 , 30 (24) : 2249 -2255 .
Year 2021 volume 30 Issue 24
39
7
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  • Online Date:2026-10-28
  • Published:2021-12-30
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  • Accepted:2021-08-19
Affiliations
    1Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
    2State Key Laboratory of Natural Medicine, Research Center of Biostatistics and Computational Pharmacy, China Pharmaceutical University, Nanjing 210009, 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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