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Scientific considerations on clinical trial design of drugs for the treatment of psoriasis
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Wen-ping YUN, Si-yuan QIAN, Cong ZHAO, Yun ZHAI, Yu-mei GE, Jing-yi YANG, Song-mei XIE
Chinese Journal of New Drugs | 2023, 32(19) : 1935 - 1940
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Chinese Journal of New Drugs | 2023, 32(19): 1935-1940
Scientific considerations on clinical trial design of drugs for the treatment of psoriasis
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Wen-ping YUN, Si-yuan QIAN, Cong ZHAO, Yun ZHAI, Yu-mei GE, Jing-yi YANG, Song-mei XIE
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
Published: 2023-10-15
Outline
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Objective:

To explore the key technical elements of clinical trial design for the treatment of plaque psoriasis vulgaris.

Methods:

By searching both relevant domestic and international literature, and combined with research and evaluation practices in China, scientific considerations on innovative drug clinical trial design for the treatment of psoriasis are summarized and proposed.

Results and Conclusion:

The overall design of clinical trials for the treatment of psoriasis vulgaris should be based on the characteristics of the disease's pathophysiology and drug action mechanisms, with a reasonable selection of control and population, as well as the design of trial duration, efficacy, and safety indicators. To comprehensively evaluate the effectiveness and safety of drugs, attention should be paid to the improvement of patients' quality of life, relapse or rebound after drug withdrawal, and long-term medication while evaluating the improvement of psoriasis symptoms and signs after drug treatment.

psoriasis  /  treatment  /  clinical trial design  /  scientific considerations
Wen-ping YUN, Si-yuan QIAN, Cong ZHAO, Yun ZHAI, Yu-mei GE, Jing-yi YANG, Song-mei XIE. Scientific considerations on clinical trial design of drugs for the treatment of psoriasis[J]. Chinese Journal of New Drugs, 2023 , 32 (19) : 1935 -1940 .
Year 2023 volume 32 Issue 19
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  • Online Date:2026-03-05
  • Published:2023-10-15
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  • Accepted:2023-09-20
Affiliations
    Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

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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