基于生物药物的皮下控制释放系统的药理动力学设计
Abigail K Grosskopf1, Antonio A Ginart2, Phillip Spinosa1
1Department of Translational Pharmacokinetics and Pharmacodynamics, Genentech Inc., South San Francisco, California, USA.
CPT: pharmacometrics & systems pharmacology
|January 24, 2025
概括
使用可控释放系统进行皮下生物制剂的输送可以提高患者的便利性并降低治疗成本. 数学建模有助于优化这些系统,以减少频率的剂量和更好的治疗结果.
科学领域:
- 生物技术是生物技术.
- 药理动力学 药理动力学
- 药物输送系统 药物输送系统
背景情况:
- 蛋白质疗法提供了有前途的治疗方法,但通常是静脉注射.
- 过渡到皮下 (SC) 给药提高了患者的便利性,并可以降低治疗成本.
- 持续释放的SC输送系统提供了诸如少频剂量和改善患者遵守等优势.
研究的目的:
- 评估控制释放的SC系统对已批准的生物制剂的药理动力学 (PK) 的影响.
- 开发一个框架,以了解和优化SC传递系统中的生物释放动态.
- 确定减少剂量频率和稳定药物度概况的机会.
主要方法:
- 利用严格的数学分析和可预测的PK模拟.
- 采用线性时间不变 (LTI) 系统理论来建模释放动态.
- 评估了PK对几种FDA批准的生物制品的影响.
主要成果:
- 展示了用于设计控制释放技术的定量指标和方法.
- 确定了降低剂量频率和稳定度配置文件的关键机会.
- 展示了生物药物的协同协同交付的潜力.
结论:
- 控制释放的SC系统具有优化生物疗法的巨大潜力.
- 药物输送和PK科学家之间的合作对于开发先进的精确疗法至关重要.
- 这些技术可以带来更方便,更有效,更以患者为中心的治疗方法.
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