钻探分析方法的"设计质量"方法
Lucas Chiarentin1,2,3, Carla Gonçalves2, Cátia Augusto2
1Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal.
Critical reviews in analytical chemistry
|September 4, 2023
概括
设计时的分析质量 (AQbD) 确保药物开发中的统一,强大的分析数据. 这种系统的方法主动地减少了方法失败,提高了效率和监管灵活性.
科学领域:
- 药品分析 药品分析
- 分析化学 分析化学
- 通过设计的质量.
背景情况:
- 制药开发在很大程度上依赖于一致的,强大的分析数据.
- 分析设计质量 (AQbD) 提高了方法质量和信心,反映了产品设计质量 (QbD).
研究的目的:
- 审查AQbD框架的元素.
- 为制药分析方法中的AQbD实施提供概述.
- 批判性地评估监管对AQbD的鼓励.
主要方法:
- 定义分析目标配置文件.
- 识别关键方法变量和属性.
- 使用风险评估和实验设计 (DOE).
- 建立一个方法可操作的设计区域 (MODR) 和控制战略.
主要成果:
- AQbD允许系统的,主动的方法开发方法,从反应性故障排除到主动性故障减少.
- 在HPLC,UV-Vis,CE,SFC和HPTLC等各种分析技术中实施了AQbD原则.
- 监管机构鼓励AQbD用于防止方法失败,并提高对MODR和控制策略的理解.
结论:
- 实施AQbD会提高方法的可靠性,并减少药物分析中的失败.
- 系统地应用AQbD原则促进了成本效益和监管灵活性.
- AQbD促进了对分析方法的更深入理解,从而提高了质量和效率.
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