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General considerations on the chemistry, manufacturing, and control research of fermented new drugs for market authorization
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Yi-fei ZHAO, Zong-ying LIU
Chinese Journal of New Drugs | 2023, 32(2) : 159 - 162
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Chinese Journal of New Drugs | 2023, 32(2): 159-162
General considerations on the chemistry, manufacturing, and control research of fermented new drugs for market authorization
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Yi-fei ZHAO, Zong-ying LIU
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Published: 2023-01-30
Outline
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The manufacturing process of fermented new drugs is complicated, and the quality control is difficult. Referring to the relevant technical guidances of new drug chemistry, manufacturing, and control research, centering on the quality control characteristics of fermented new drugs, this article discusses the general considerations on the manufacturing process, elucidation of structure, specification research, to provide a reference for the research of fermented new drugs.

fermentation  /  new drugs  /  process development  /  specification
Yi-fei ZHAO, Zong-ying LIU. General considerations on the chemistry, manufacturing, and control research of fermented new drugs for market authorization[J]. Chinese Journal of New Drugs, 2023 , 32 (2) : 159 -162 .
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:2022-12-21
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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