基于无维质量的规模无定性模型被设计为制药发展加速器
Miquel Romero-Obon1, Virginia Sancho-Ochoa1, Khadija Rouaz-El-Hajoui1,2
1Department of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Av. Joan XXIII, 27-31, 08028 Barcelona, Spain.
设计质量 (QbD) 和Pi-Buckingham定理增强了制药产品的开发. 这种协同作用通过控制关键质量属性来改善流程优化和制造结果.
科学领域:
- 制药科学 制药科学
- 化学工程是化学工程的重要组成部分.
- 工艺系统工程 工艺系统工程
背景情况:
- 设计质量 (QbD) 是制药开发的监管范式.
- 皮-白金汉定理是维度分析中的一个基本工具,用于简化复杂系统.
- 将QbD与维度分析集成,为过程理解提供了一种新的方法.
研究的目的:
- 探索QbD和Pi-Buckingham定理的协同应用.
- 加强制药产品开发和流程优化.
- 改善关键质量属性 (CQA) 的控制.
主要方法:
- 通过设计审查质量原则.
- 使用Pi-Buckingham定理对制药过程应用维度分析.
- 分析无维参数对CQA的影响.
主要成果:
- 这种协同作用使得我们能够更有系统地理解过程变量.
- 确定影响CQAs的关键无维群体.
- 提高预测和控制制造变化的能力.
结论:
- 综合方法为制药过程优化提供了一个强大的框架.
- 这种方法有助于开发更安全,更有效的药品.
- 加强对CQA的控制可以提高制造的一致性和产品质量.
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