Romero-Obon Miquel, Sancho-Ochoa Virginia, Rouaz-El-Hajoui Khadija, Pérez-Lozano Pilar, Suñé-Pou Marc, Suñé-Negre Josep María, García-Montoya Encarna
Department 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.
Pharmacotherapy, Pharmacogenetics and Pharmaceutical Technology Research Group, Bellvitge Biomedical Research Institute (IDIBELL), Av. Gran via de l'Hospitalet, 199-203, 08090 Barcelona, Spain.
Pharmaceuticals (Basel). 2025 Jul 11;18(7):1033. doi: 10.3390/ph18071033.
This comprehensive review of the synergistic use of Quality by Design (QbD) and the Pi-Buckingham theorem explores an innovative approach to enhancing product development and process optimization within the pharmaceutical industry. QbD is a systematic, proactive methodology that integrates quality considerations throughout the product lifecycle to ensure that pharmaceutical products meet regulatory standards for safety and efficacy from the outset of development. The Pi-Buckingham theorem serves as a foundational principle in dimensional analysis, facilitating the simplification of complex models by transforming physical variables into dimensionless parameters. This synergy enables researchers to better understand and control the factors affecting critical quality attributes (CQAs), thereby improving manufacturing outcomes and minimizing variability.
对质量源于设计（QbD）与π-白金汉定理协同使用的这一全面综述，探索了一种创新方法，以加强制药行业内的产品开发和工艺优化。质量源于设计是一种系统的、主动的方法，它在产品整个生命周期内整合质量考量，以确保药品从开发之初就符合安全和有效性的监管标准。π-白金汉定理是量纲分析中的一个基本原理，通过将物理变量转化为无量纲参数，有助于简化复杂模型。这种协同作用使研究人员能够更好地理解和控制影响关键质量属性（CQA）的因素，从而改善生产结果并将变异性降至最低。
