使用蒙特卡洛方法的溶解试验的测量不确定性 - - 采样和分析步骤产生的不确定性
Maisa Torres Martins1, Felipe Rebello Lourenço1
1Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, Av. Prof. Lineu Prestes, 580, CEP 05508-000, São Paulo, SP, Brazil.
Analytica chimica acta
|November 3, 2024
概括
药品溶解测试中的测量不确定性可能导致错误的质量决定. 本研究量化了这些不确定性,发现采样是最大的贡献者,并提出了改进的标准,以尽量减少虚假合规风险.
科学领域:
- 制药品质量控制 制药品质量控制
- 分析化学 分析化学
- 测量科学 测量科学 测量科学
背景情况:
- 溶解试验对于药品质量控制至关重要,评估药物的生物可用性和批量一致性.
- 溶解测试中的测量不确定性可能导致不准确的符合性决定.
- 现有的方法可能无法充分考虑与测量不确定性相关的风险.
研究的目的:
- 量化溶解测试的溶解,采样和量化阶段的测量不确定性.
- 估计在平板电脑溶解测试中错误的符合性决定的风险.
- 引入新的,改进的溶解测试标准,以减轻测量不确定性带来的风险.
主要方法:
- 通过溶解,采样和量化进行全面的不确定性评估.
- 应用蒙特卡洛方法 (MCM) 来评估整体测量不确定性.
- 开发一个MS Excel工具来计算风险值和分类生产者/消费者风险.
主要成果:
- 总体测量不确定性约为5.2%,采样贡献了92%的不确定性.
- 量化为总不确定性贡献了7%,溶解步骤为1%.
- 开发的MS Excel工具有效评估了不确定性,并管理了消费者风险.
结论:
- 引入了溶解测试的新标准,大大提高了药物质量评估的可靠性.
- 该研究提供了一个强大的框架,以尽量减少药品质量控制中的错误合规决定.
- 开发的实用工具支持可靠的溶解试验结果评估,确保更高的药物安全性和疗效标准.
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