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Interpretation of Guidance on Quality Control for Nanomedicines
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Junlin ZHANG1, Wenbing DAI2, Qiang ZHANG2, Fanghua HUANG1, Zhenyu XU1
Chinese Pharmaceutical Journal | 2024, 59(19) : 1874 - 1880
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Chinese Pharmaceutical Journal | 2024, 59(19): 1874-1880
Interpretation of Guidance on Quality Control for Nanomedicines
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Junlin ZHANG1, Wenbing DAI2, Qiang ZHANG2, Fanghua HUANG1, Zhenyu XU1
Affiliations
  • 1 Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
  • 2 Beijing Key Laboratory of Molecular Pharmaceutics and New Drug Delivery Systems, School of Pharmaceutical Sciences, Peking University, Beijing 100191, China
Published: 2024-10-08
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OBJECTIVE To interpret Guidance on Quality Control for Nanomedicines (interim) issued by center for drug evaluation, NMPA, and provide reference for the development of nanomedicines. METHODS By conducting a systematic review of domestic and international literature and combining background of the guidance, this paper discussed the definition and classification of nanomedicines, quality research and control strategies, process control and stability research. It also proposes points of attention in the quality control studies of nanomedicines with cases. RESULTS and CONCLUSION The special nano-size, structure and surface properties of nanomedicines may significantly change the physicochemical properties and behaviors of active pharmaceutical ingredients in vitro and in vivo, which in turn affect their safety and efficacy. Quality research spans the entire lifecycle of nanomedicines. Critical quality attributes related to nano-characteristics should be evaluated based on the type, composition and structure of nanomedicines, manufacturing process, as well as their clinical use. Risk assessment strategy based on drug evaluation should focus on the impact of the quality attributes of nanomedicines on their safety and efficacy.

nanomedicine  /  quality control  /  guidance interpretation  /  drug nanoparticle  /  carrier-based nanomedicine
Junlin ZHANG, Wenbing DAI, Qiang ZHANG, Fanghua HUANG, Zhenyu XU. Interpretation of Guidance on Quality Control for Nanomedicines[J]. Chinese Pharmaceutical Journal, 2024 , 59 (19) : 1874 -1880 .
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  • Receive Date：2023-08-17
  • Online Date：2025-12-30
  • Published：2024-10-08
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  • Received：2023-08-17
Affiliations
    1 Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
    2 Beijing Key Laboratory of Molecular Pharmaceutics and New Drug Delivery Systems, School of Pharmaceutical Sciences, Peking University, Beijing 100191, China
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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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