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Considerations on pharmaceutical quality assessment and control of lipid nanoparticles of prophylactic mRNA vaccines
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Dan YANG, Xin ZHAO, Xiao-jing LI, Min LI
Chinese Journal of New Drugs | 2023, 32(24) : 2452 - 2456
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Chinese Journal of New Drugs | 2023, 32(24): 2452-2456
Considerations on pharmaceutical quality assessment and control of lipid nanoparticles of prophylactic mRNA vaccines
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Dan YANG, Xin ZHAO, Xiao-jing LI, Min LI
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100038, China
Published: 2023-12-30
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As the continuous in-depth research on prophylactic mRNA vaccines, new questions have been raised about lipid nanoparticles in aspects of structures and morphologies. Based on the principle of ICH Q6B, the characteristics and changes of the structures of lipid nanoparticles were preliminarily discussed from the perspective of pharmaceutical evaluation, and the additional study for the structural characteristics were also addressed for providing a reference for the quality assessment and control of prophylactic mRNA vaccines.

mRNA vaccine  /  lipid nanoparticle  /  particle size  /  morphology  /  process control  /  quality study
Dan YANG, Xin ZHAO, Xiao-jing LI, Min LI. Considerations on pharmaceutical quality assessment and control of lipid nanoparticles of prophylactic mRNA vaccines[J]. Chinese Journal of New Drugs, 2023 , 32 (24) : 2452 -2456 .
Year 2023 volume 32 Issue 24
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  • Online Date:2026-03-05
  • Published:2023-12-30
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History
  • Accepted:2023-11-10
Affiliations
    Center for Drug Evaluation, National Medical Products Administration, Beijing 100038, 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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