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The concept of analytical quality by design (AQbD) guides pharmaceutical industries in the development and maintenance of systematic analytical procedures using scientific knowledge and quality risk management approach. The quality control of biological products is the critical content of the pharmaceutical research and evaluation, and is important to ensure the safety, effectiveness and stability of products. The analytical procedures used for quality control contribute to the quality control system. Lifecycle management of analytical procedures includes analytical procedure development, validation, transfer, change and continual improvement. This article introduced the concept and application of lifecycle management of analytical procedures and regulatory considerations according to the quality control characteristics of biologics and the experience of drug evaluation.

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分析质量源于设计(analytical quality by design, AQbD)的理念指引着制药企业运用科学知识和质量风险管理进行系统的分析方法开发和维护。生物制品的质量控制部分是其药学研究和评价的关键内容,是保证药物安全有效、持续稳定的重要手段。质量控制采用的分析方法关系着质量控制体系是否可靠。分析方法的生命周期管理包括分析方法的开发、验证、转移、变更、持续改进等多个阶段。本文将根据生物制品的质量控制特点和药学审评经验,介绍分析方法生命周期管理的概念、应用以及审评考虑。

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魏开坤,男,博士,主要从事生物制品药学评价工作。联系电话:(010)85243021,E-mail:
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李怡君,女,硕士,助理研究员,主要从事生物制品药学评价工作。联系电话:(010)85242998,E-mail:

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李怡君,女,硕士,助理研究员,主要从事生物制品药学评价工作。联系电话:(010)85242998,E-mail:

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李怡君,女,硕士,助理研究员,主要从事生物制品药学评价工作。联系电话:(010)85242998,E-mail:

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生物制品分析方法的生命周期管理
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李怡君 , 何伍 , 魏开坤
中国新药杂志 | 新药注册与审评技术 2023,32(2): 181-188
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中国新药杂志 | 新药注册与审评技术 2023, 32(2): 181-188
生物制品分析方法的生命周期管理
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李怡君 , 何伍, 魏开坤
作者信息
  • 国家药品监督管理局药品审评中心,北京 100022
  • 李怡君,女,硕士,助理研究员,主要从事生物制品药学评价工作。联系电话:(010)85242998,E-mail:

通讯作者:

魏开坤,男,博士,主要从事生物制品药学评价工作。联系电话:(010)85243021,E-mail:
Lifecycle management of analytical procedures of biological products
Yi-jun LI , Wu HE, Kai-kun WEI
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
出版时间: 2023-01-30
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分析质量源于设计(analytical quality by design, AQbD)的理念指引着制药企业运用科学知识和质量风险管理进行系统的分析方法开发和维护。生物制品的质量控制部分是其药学研究和评价的关键内容,是保证药物安全有效、持续稳定的重要手段。质量控制采用的分析方法关系着质量控制体系是否可靠。分析方法的生命周期管理包括分析方法的开发、验证、转移、变更、持续改进等多个阶段。本文将根据生物制品的质量控制特点和药学审评经验,介绍分析方法生命周期管理的概念、应用以及审评考虑。

分析方法开发  /  方法学验证  /  质量控制  /  生命周期管理

The concept of analytical quality by design (AQbD) guides pharmaceutical industries in the development and maintenance of systematic analytical procedures using scientific knowledge and quality risk management approach. The quality control of biological products is the critical content of the pharmaceutical research and evaluation, and is important to ensure the safety, effectiveness and stability of products. The analytical procedures used for quality control contribute to the quality control system. Lifecycle management of analytical procedures includes analytical procedure development, validation, transfer, change and continual improvement. This article introduced the concept and application of lifecycle management of analytical procedures and regulatory considerations according to the quality control characteristics of biologics and the experience of drug evaluation.

analytical procedure development  /  analytical validation  /  quality control  /  lifecycle management
李怡君, 何伍, 魏开坤. 生物制品分析方法的生命周期管理. 中国新药杂志, 2023 , 32 (2) : 181 -188 .
Yi-jun LI, Wu HE, Kai-kun WEI. Lifecycle management of analytical procedures of biological products[J]. Chinese Journal of New Drugs, 2023 , 32 (2) : 181 -188 .
2023年第32卷第2期
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  • 首发时间:2026-03-05
  • 出版时间:2023-01-30
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  • 录用日期:2022-11-14
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    国家药品监督管理局药品审评中心,北京 100022

通讯作者:

魏开坤,男,博士,主要从事生物制品药学评价工作。联系电话:(010)85243021,E-mail:
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2种不同金属材料的力学参数

Family
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Number of
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种数
Number of
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Percentage of
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Genus
种数
Number of
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占总种数比例
Percentage of total
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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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