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Some opinions about analytical method validation in drug research and development
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Fei LI1, Yun LI2
Chinese Journal of New Drugs | 2021, 30(10) : 902 - 904
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Chinese Journal of New Drugs | 2021, 30(10): 902-904
Some opinions about analytical method validation in drug research and development
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Fei LI1, Yun LI2
Affiliations
  • 1Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
  • 2Zhongguancun Outpatient Department, Central Medical District of Chinese PLA General Hospital, Beijing 100038, China
Published: 2021-05-30
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This article explained the purpose of analytical method validation, pointed out that there are many problems and misunderstandings about method validation in drug research and development, and gave some opinions and suggestions according to the authors' experience, expecting for higher demand from the regulatory authorities.

analytical method  /  validation  /  data
李飞, 李云. 对药物研发中分析方法验证的几点考虑. 中国新药杂志, 2021 , 30 (10) : 902 -904 .
Fei LI, Yun LI. Some opinions about analytical method validation in drug research and development[J]. Chinese Journal of New Drugs, 2021 , 30 (10) : 902 -904 .
Year 2021 volume 30 Issue 10
45
6
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  • Online Date:2026-10-28
  • Published:2021-05-30
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  • Accepted:2021-02-02
Affiliations
    1Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
    2Zhongguancun Outpatient Department, Central Medical District of Chinese PLA General Hospital, Beijing 100038, 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
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Percentage of
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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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