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The key issues in clinical research of investigational Chinese medicine in mammary hyperplasia
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Jin-lian CHENG, Dong-xiao ZHANG, Xue-mei LIU
Chinese Journal of New Drugs | 2021, 30(21) : 1961 - 1966
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收藏切换
Chinese Journal of New Drugs | 2021, 30(21): 1961-1966
The key issues in clinical research of investigational Chinese medicine in mammary hyperplasia
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Jin-lian CHENG, Dong-xiao ZHANG, Xue-mei LIU
Affiliations
  • Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China
Published: 2021-11-15
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Under the background of big changes in drug regulatory policies, the ideas on research and development of investigational Chinese medicine are converting into “clinical value-oriented”, “safety and efficacy evaluation methods in line with the characteristics of TCM” and “highlighting the advantages of TCM in disease treatment”. Based on the overall research idea of clinical value orienting and the reflecting of characteristics of TCM, this article mainly discusses the key issues in clinical research of investigational chinese medicine in the treatment of mammary hyperplasia based on six aspects, including feasibility analysis of project approval, positioning of clinical research, overall considerations and key issues of clinical trial protocol design, safety assessment of investigational Chinese medicine, as well as quality control measures.

mammary hyperplasia  /  traditional Chinese medicine (TCM)  /  protocol design of clinical trials  /  clinical value
程金莲, 张董晓, 刘雪梅. 乳腺增生症中药新药临床研究关键问题. 中国新药杂志, 2021 , 30 (21) : 1961 -1966 .
Jin-lian CHENG, Dong-xiao ZHANG, Xue-mei LIU. The key issues in clinical research of investigational Chinese medicine in mammary hyperplasia[J]. Chinese Journal of New Drugs, 2021 , 30 (21) : 1961 -1966 .
Year 2021 volume 30 Issue 21
27
6
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  • Online Date:2026-10-30
  • Published:2021-11-15
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  • Accepted:2021-02-02
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    Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, 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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