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Analysis on the necessity of international multi-regional clinical trials of imported prophylactic vaccines in China
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Ze-lin LI1, Jian-hong YANG2, Jiang-ping DONG3
Chinese Journal of New Drugs | 2021, 30(21) : 1928 - 1933
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Chinese Journal of New Drugs | 2021, 30(21): 1928-1933
Analysis on the necessity of international multi-regional clinical trials of imported prophylactic vaccines in China
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Ze-lin LI1, Jian-hong YANG2, Jiang-ping DONG3
Affiliations
  • 1School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
  • 2School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100055, China
  • 3Center for Food and Drug Inspection of National Medical Products Administration, Beijing 100044, China
Published: 2021-11-15
Outline
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Based on comparison of the marketing time of vaccines approved through multi-regional clinical trials (MRCT) between the United States and China in the past 20 years, representative varieties were selected for case analysis. We systematically analyzed the necessity of conducting international MRCT of vaccines in China, and the system advantages and management strategy of prophylactic vaccine clinical trial, further providing suggestions on feasibility of putting it forward.

prophylactic vaccine  /  international multi-regional clinical trial  /  imported vaccine
黎泽琳, 杨建红, 董江萍. 我国开展进口预防性疫苗国际多中心临床试验的必要性. 中国新药杂志, 2021 , 30 (21) : 1928 -1933 .
Ze-lin LI, Jian-hong YANG, Jiang-ping DONG. Analysis on the necessity of international multi-regional clinical trials of imported prophylactic vaccines in China[J]. Chinese Journal of New Drugs, 2021 , 30 (21) : 1928 -1933 .
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Year 2021 volume 30 Issue 21
27
5
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  • Online Date：2026-10-30
  • Published：2021-11-15
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  • Accepted：2021-04-10
Affiliations
    1School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
    2School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100055, China
    3Center for Food and Drug Inspection of National Medical Products Administration, Beijing 100044, 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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