评估以患者为中心的样本采集技术,用于大分子和小分子的药理动力学评估
Sandhya Mandlekar1, Dhruvitkumar S Sutaria1, Xiaoyun Yang1
1Genentech, Inc., South San Francisco, California, USA.
Clinical pharmacology and therapeutics
|April 27, 2024
概括
低容量的血液采集设备提供了与单克隆抗体和一些小分子传统静脉穿刺可比的药理动力学数据,提高了临床试验中患者的便利性.
科学领域:
- 药理动力学和药物开发
- 生物技术和生物分析
- 临床试验方法论 临床试验方法论
背景情况:
- 低体积血液采样提供了改善的患者舒适性和便利性.
- 分散的临床试验可以从降低患者负担中受益.
- 评估低容量采样设备与静脉穿刺器的可比性对于其采用至关重要.
研究的目的:
- 为了评估低体积采样设备是否能产生与传统静脉穿刺可比的药理动力学数据.
- 评估各种药物类型的设备性能:单克隆抗体和小分子.
- 研究将干血度转化为血度的策略.
主要方法:
- 开放式,非随机,并行组研究,包括四个队列 (10个健康受试者/手臂).
- 研究的药物:克雷内祖马布,埃特罗利祖马布,GDC-X和氧化 (HCQ).
- 通过静脉穿刺和三种低体积装置 (TassoOne Plus,Tasso-M20,Neoteryx Mitra®) 采样样本.
主要成果:
- 所有药物 (除HCQ外) 的血清/血度和PK参数在静脉穿刺和TassoOne Plus之间是可比的.
- 单克隆抗体的干血PK参数与血液度纠正后的静脉穿刺相似.
- 对于GDC-X而言,已确定干血转化为血度的有效转化策略,但未确定HCQ.
结论:
- 低容量采样设备,特别是TassoOne Plus,显示出可用于生成与mAbs和一些小分子静脉穿孔相比较的PK数据的潜力.
- 干血采样需要针对小分子的特定转化策略,成功程度各不相同.
- 这些发现支持了在分散的临床试验中低容量设备的潜力,并改善了患者体验.
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