一个数据驱动的策略和案例研究,用于实施单元分析在PK量化用于PK结合试验的单元分析
Qiang Qu1, Susana Liu2, Zhiping You3
1Clinical Bioanalytics, Pfizer Inc, Andover, USA. qiang.0.qu@pfizer.com.
The AAPS journal
|July 31, 2024
概括
本研究介绍了一种基于数据的策略,用于在配体结合试验 (LBAs) 中实施单井 (单基质) 分析. 结果表明单基分析适用于受管制的生物分析,支持临床药理动力学研究.
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
- 测试开发 测试开发
背景情况:
- 复制分析是像ELISA和MSD这样的带结合试验 (LBA) 的标准.
- 为了规范生物分析,将LBAs转换为单井 (单) 分析面临着战略性挑战.
- 最近的指导建议鼓励探索LBAs的单一方法.
研究的目的:
- 提出一个数据驱动的策略,用于在板式LBA中实施单酸盐分析.
- 通过单位方法验证临床药理动力学 (PK) 测定.
- 评估单酸盐分析对于受管制生物分析的适用性.
主要方法:
- 进行了对重复和单重复格式的对比比较.
- 精度和准确性在双重和单重测定格式中进行了评估.
- 统计分析评估了方法变异性,并收集了持续样本再分析 (ISR) 数据.
主要成果:
- 在重复和单重分析之间没有观察到精度和准确性的显著差异.
- 使用单酸盐分析进行的测试验证符合所有监管接受标准.
- 使用单酸盐方法分析的ISR样本中有90.1%符合可接受的标准.
结论:
- 数据驱动策略有效地促进了LBAs向单元分析的过渡.
- 单基质分析是一种可行且经过验证的方法,用于支持受监管的PK生物分析.
- 这种经过验证的单基质LBA测定已在I期临床研究中成功应用.
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