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生物分析方法验证中的全血稳定性:欧洲生物分析论坛的最新建议

Lee Goodwin¹, Jörg Faber², Kristina H Holmberg³

¹Labcorp, Bioanalytical Services, Harrogate, UK.

|June 19, 2025

概括

欧洲生物分析论坛更新了用于生物分析方法验证的全血稳定性测试建议. 这些指南确保精确的分析物度反映收集时间,与ICH M10标准保持一致.

科学领域:

生物分析化学生物分析化学
药理动力学药理动力学
药物开发药物开发

背景情况:

国际协调理事会 (ICH) M10指南强调了在整个样品生命周期中分析物的稳定性.
准确的分析量化需要立即收集后进行稳定性评估,特别是在全血中.
生物分析方法验证对于可靠的药物开发研究至关重要.

研究的目的:

提出更新的欧洲生物分析论坛 (EBF) 关于全血稳定性测试的建议.
为基于ICH M10的生物分析方法验证提供实用指南.
针对ICH M10指南和培训材料的社区反.

主要方法:

基于共识的EBF社区的推开发.
考虑对ICH M10指南和培训材料的反.
专注于全血稳定性评估的实际方面.

主要成果:

在生物分析方法验证中对全血稳定性测试的最新建议.
关于定义新鲜血液,平衡时间和测试类型的指导.
在实验设计中考虑3R原则 (取代,减少,改进).

结论:

EBF的建议支持强大的生物分析方法验证.
遵守这些准则可以确保全血样中的分析物度的完整性.
这些建议有助于遵守ICH M10药物开发标准.

关键词:

这是一个ADCADC ADC.ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME 测试试验测试试验测试试验自动化自动化自动化自动化生物标志物生物标志物生物治疗药物生物治疗药物染色体学染色体学染色体学

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