通过非目标分析 (NTA) 识别和量化医疗器械的可提取和可浸出物;分析不确定性
Dennis Jenke1, Piet Christiaens2, Ted Heise3
1Triad Scientific Solutions, LLC, 181 Peregrine Lane, Hawthorn Woods, IL 60047, USA.
Journal of pharmaceutical and biomedical analysis
|February 1, 2024
概括
医疗器械被选,以确保患者的安全. 本研究解决了因不同响应因子而导致的量化分析不确定性,为更好的评估提出了不确定性因子 (UF).
科学领域:
- 分析化学 分析化学
- 材料科学 材料科学 材料科学
- 生物医学工程 生物医学工程
背景情况:
- 医疗器械中的漏物对患者健康构成风险.
- 医疗器械对可浸出物进行分析对于安全性评估至关重要.
- 由于可变的响应因子,目前的方法在量化方面面临挑战.
研究的目的:
- 讨论漏分析中的分析不确定性的概念和影响.
- 为计算和使用不确定性因子 (UF) 提供建议.
- 提高漏量测量和风险评估的准确性.
主要方法:
- 使用染色学方法与质谱学相结合的非向分析 (NTA).
- 医疗器械提取物/洗液的查有机物质.
- 开发和应用不确定性因子 (UF) 来解决响应因子变化.
主要成果:
- 浸出物和提取物的响应因子有很大差异.
- 这种变化使准确的量化和评估策略,如分析评估值 (AET) 变得复杂.
- 不确定性因子 (UF) 量化了这种分析不确定性的影响.
结论:
- 由于响应因子的变化导致的分析不确定性是漏分析的一个重大挑战.
- 不确定性因子 (UF) 提供了一种管理和报告这种不确定性的方法.
- 实施UF建议可以提高医疗器械安全评估的可靠性.
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