用于药理动力学分析的低容量采样设备的验证:技术和后勤方面的挑战和解决方案
Xiaoyun Yang1, Kathi Williams1, Rebecca Elliott1
1BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.
像Mitra和Tasso-M20这样的低容量血液采样设备可以在临床试验中准确测量crenezumab和etrolizumab. 这项研究解决了挑战,并为其药理动力学分析提供了解决方案.
科学领域:
- 药理动力学 药理动力学
- 生物分析化学 生物分析化学
- 临床试验方法论临床试验方法论
背景情况:
- 低体积血液采样比传统静脉穿刺具有优势,但在临床试验中面临实施障碍.
- 精确量化治疗药物在小体积的血液中对于药理动力学研究至关重要.
研究的目的:
- 通过Mitra和Tasso-M20设备的干血样本验证crenezumab和etrolizumab的生物分析方法.
- 评估挑战,并提出解决方案,用于在药物动力学分析中利用低容量采样技术.
主要方法:
- 在干血斑点 (DBS) 中验证了crenezumab和etrolizumab的生物分析试验.
- 使用血清校准器量化和患者血红素转换到血清度.
- 通过经验丰富的合同研究组织分析,对Mitra和Tasso-M20设备的性能进行比较.
主要成果:
- 从两种设备的DBS中,使用血清校准器精确确定了crenezumab和etrolizumab的度.
- 在DBS中药物度与血清度相关,当调整为血红素时.
- 证明了使用这些设备进行药理动力学分析的可行性,并采用适当的方法.
结论:
- 在临床试验中,低体积血液采样技术可用于对克雷涅祖马布和埃特罗利祖马布的药理学分析.
- 经过验证的方法和基于血清的校准克服了与干血矩阵相关的挑战.
- 成功实施需要仔细考虑样本处理和分析程序.
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