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Considerations on pharmaceutical review for viral safety of blood products
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Dong-chen JIA, Peng-li YU, Zhou-yi WU, Wei WEI
Chinese Journal of New Drugs | 2023, 32(2) : 168 - 173
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Chinese Journal of New Drugs | 2023, 32(2): 168-173
Considerations on pharmaceutical review for viral safety of blood products
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Dong-chen JIA, Peng-li YU, Zhou-yi WU, Wei WEI
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Published: 2023-01-30
Outline
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Blood products are manufactured by separation of plasma from healthy donors, which have a wide range of indications and play a critical role in the prevention and treatment of certain major diseases. However, because of the uniqueness of their source, the viral safety of blood products is always highly concerned by various national regulatory authorities. This manuscript discussed viral safety-related issues of blood products in combination with technical review practice, from aspects like source plasma, virus removal/inactivation processes, regulation requirements and considerations in technical review, etc., in order to provide references for future research and development.

blood products  /  viral safety  /  source plasma  /  virus removal/inactivation
Dong-chen JIA, Peng-li YU, Zhou-yi WU, Wei WEI. Considerations on pharmaceutical review for viral safety of blood products[J]. Chinese Journal of New Drugs, 2023 , 32 (2) : 168 -173 .
Year 2023 volume 32 Issue 2
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  • Online Date:2026-03-05
  • Published:2023-01-30
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History
  • Accepted:2022-12-30
Affiliations
    Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, 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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