从常规测试中估计分析方法变异性的实用方法
1Gilead Alberta ULC, 1021 Hayter Road NW, Edmonton, AB T6S 1A1, Canada.
Journal of pharmaceutical and biomedical analysis
|July 25, 2024
概括
一种新方法评估了常规使用期间分析测试方法的变化. 这种方法确保了制药产品的质量,并支持方法生命周期管理,以实现可靠,具有成本效益的验证计划.
科学领域:
- 药品分析 药品分析
- 分析方法生命周期管理
背景情况:
- 分析方法的性能对于制药产品的质量和有效性至关重要.
- 在整个方法生命周期中,对偏差和精度等方法属性的持续验证至关重要,根据USP <1220>和ICH Q14.
- 成熟的验证计划需要先进的,具有成本效益的监控工具.
研究的目的:
- 介绍一种用于直接从例行执行数据评估分析方法变量的新方法.
- 为了证明该方法在特定的液体染色体检测中实现了该方法.
- 讨论数据减少,更广泛的适用性和在方法开发中使用的方法.
主要方法:
- 开发了一种新的方法来评估使用常规数据的分析方法可变性.
- 将该方法应用于一个小分子液体色谱测定与单点外部校准.
- 探索了数据最小化和扩展方法范围的策略.
主要成果:
- 提出的方法允许直接评估分析方法与常规结果的差异性.
- 在液体染色学试验中成功证明了实施.
- 讨论了减少数据要求和增加适用性的考虑.
结论:
- 这种新的方法为持续的分析方法验证提供了一种强大且具有成本效益的方法.
- 它有助于在方法开发过程中识别变异源,并选择最佳的复制策略.
- 这有助于全面了解整个方法生命周期的方法可变性.
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