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Interpretation of “Guidance on Pharmaceutical Development of Paediatric Medicines”
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Juan LIU, Lian-jie REN
Chinese Journal of New Drugs | 2021, 30(23) : 2147 - 2152
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Chinese Journal of New Drugs | 2021, 30(23): 2147-2152
Interpretation of “Guidance on Pharmaceutical Development of Paediatric Medicines”
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Juan LIU, Lian-jie REN
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Published: 2021-12-15
Outline
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“Guidance on Pharmaceutical Development of Paediatric Medicines” was issued by National Medical Products Administration on December 2020, aiming to encourage and facilitate the development and accessibility of paediatric medicines. This paper provides a detailed interpretation of the guidance, combined with the drafting process of the guidance and the current state of the pharmaceutical development level in China. The paper is intended to help applicants getting a better understanding of the scientific and technical requirements for pharmaceutical development of paediatric medicines.

paediatric medicines  /  pharmaceutical development  /  technical requirements
刘涓, 任连杰. 《儿童用药(化学药品)药学开发指导原则(试行)》解读. 中国新药杂志, 2021 , 30 (23) : 2147 -2152 .
Juan LIU, Lian-jie REN. Interpretation of “Guidance on Pharmaceutical Development of Paediatric Medicines”[J]. Chinese Journal of New Drugs, 2021 , 30 (23) : 2147 -2152 .
Year 2021 volume 30 Issue 23
57
11
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  • Online Date:2026-10-28
  • Published:2021-12-15
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  • Accepted:2021-10-26
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
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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