以患者为中心的质量标准
Anthony Mire-Sluis1, John Dobbins2, Christine M V Moore3
1Global Product Quality, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD, 20878, USA.
Journal of pharmaceutical sciences
|January 27, 2024
概括
制定以患者为中心的质量标准 (PCQS) 通过关注与患者健康结果相关的属性,确保药品质量,安全性和有效性. 这种方法改进了传统的控制策略,以提高患者安全.
科学领域:
- 制药科学 制药科学
- 药物开发 药物开发
- 监管科学 监管科学
背景情况:
- 传统的药品质量控制依赖于测试已知的属性,其限制来自临床前/临床研究.
- 并非所有质量属性都会在治疗剂量下显著影响患者的安全性或疗效.
- 现有的策略可能无法完全捕捉患者对产品控制的相关性.
研究的目的:
- 在制药质量标准中引入患者中心的概念.
- 定义与患者相关的属性及其对暴露范围内的安全性和疗效的影响.
- 描述以患者为中心的质量标准 (PCQS) 的创建和应用.
主要方法:
- 对药物产品控制的历史观点的回顾.
- 定义患者与质量属性的相关性.
- 制定和利用以患者为中心的质量标准 (PCQS) 的框架.
主要成果:
- 以患者为中心包括了解质量属性对患者相关水平的安全性和疗效的影响.
- 一个以患者为中心的质量标准 (PCQS) 包含患者相关的属性和接受范围.
- PCQS可以应用于各种类型的制药产品.
结论:
- 转向以患者为中心的质量标准,提高了对患者安全和治疗疗效的关注.
- PCQS为制定药物产品有意义的接受标准提供了一个框架.
- 这种方法优化了制造过程和产品控制策略,使患者受益.
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