药理动力学 - - 自动注射器和预装注射器之间的桥梁,用于皮下注射:案例示例揭示了知识差距
Zhe Li1, Xiulian Du1, Shiew Mei Huang1
1Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration (OCP/CDER/FDA), Silver Spring, Maryland, USA.
Clinical pharmacology and therapeutics
|January 3, 2024
概括
比较的药理动力学研究跨越了自动注射器和预填注射器. 这篇文章涉及非可比的PK,使生物药物的新自喷器设备成为可能.
科学领域:
- 药理动力学 药理动力学
- 生物制品 输送装置 生物制品 输送装置
背景情况:
- 对比性药理动力学 (PK) 研究对于桥梁自动注射器和预填注射器至关重要.
- 原则是,可比的药物暴露可以确保可比的有效性和安全性.
研究的目的:
- 讨论从非可比的PK数据管理不确定性的方法.
- 突出成功的策略,引入新的生物产品自动注射器设备.
主要方法:
- 审查处理非可比的PK数据的方法.
- 分析涉及开发生物药物的自注射器的案例.
主要成果:
- 尽管没有可比的PK观测,但成功引入了新的自动注射器设备.
- 识别自动注射器开发中的知识差距.
结论:
- 解决PK的不确定性是推动自动注射器技术发展的关键.
- 需要进一步关注知识差距,以实现最佳的自注射器开发,特别是单克隆抗体和Fc融合蛋白产品.
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