Scale-Agnostic Models Based on Dimensionless Quality by Design as Pharmaceutical Development Accelerator
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 c...
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| Format: | Article |
| Language: | English |
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MDPI AG
2025-07-01
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| Series: | Pharmaceuticals |
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| Online Access: | https://www.mdpi.com/1424-8247/18/7/1033 |
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| author | Miquel Romero-Obon Virginia Sancho-Ochoa Khadija Rouaz-El-Hajoui Pilar Pérez-Lozano Marc Suñé-Pou Josep María Suñé-Negre Encarna García-Montoya |
| author_facet | Miquel Romero-Obon Virginia Sancho-Ochoa Khadija Rouaz-El-Hajoui Pilar Pérez-Lozano Marc Suñé-Pou Josep María Suñé-Negre Encarna García-Montoya |
| author_sort | Miquel Romero-Obon |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-e2d1075c57c24ab6beea71d2dd745142 |
| institution | Kabale University |
| issn | 1424-8247 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj-art-e2d1075c57c24ab6beea71d2dd7451422025-08-20T03:56:49ZengMDPI AGPharmaceuticals1424-82472025-07-01187103310.3390/ph18071033Scale-Agnostic Models Based on Dimensionless Quality by Design as Pharmaceutical Development AcceleratorMiquel Romero-Obon0Virginia Sancho-Ochoa1Khadija Rouaz-El-Hajoui2Pilar Pérez-Lozano3Marc Suñé-Pou4Josep María Suñé-Negre5Encarna García-Montoya6Department of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Av. Joan XXIII, 27-31, 08028 Barcelona, SpainDepartment of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Av. Joan XXIII, 27-31, 08028 Barcelona, SpainDepartment of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Av. Joan XXIII, 27-31, 08028 Barcelona, SpainDepartment of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Av. Joan XXIII, 27-31, 08028 Barcelona, SpainDepartment of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Av. Joan XXIII, 27-31, 08028 Barcelona, SpainDepartment of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Av. Joan XXIII, 27-31, 08028 Barcelona, SpainDepartment of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Av. Joan XXIII, 27-31, 08028 Barcelona, SpainThis 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.https://www.mdpi.com/1424-8247/18/7/1033Quality by Designdesign spacePi–Buckinghamdimensional analysisdesign of experimentspharmaceutical process development |
| spellingShingle | Miquel Romero-Obon Virginia Sancho-Ochoa Khadija Rouaz-El-Hajoui Pilar Pérez-Lozano Marc Suñé-Pou Josep María Suñé-Negre Encarna García-Montoya Scale-Agnostic Models Based on Dimensionless Quality by Design as Pharmaceutical Development Accelerator Pharmaceuticals Quality by Design design space Pi–Buckingham dimensional analysis design of experiments pharmaceutical process development |
| title | Scale-Agnostic Models Based on Dimensionless Quality by Design as Pharmaceutical Development Accelerator |
| title_full | Scale-Agnostic Models Based on Dimensionless Quality by Design as Pharmaceutical Development Accelerator |
| title_fullStr | Scale-Agnostic Models Based on Dimensionless Quality by Design as Pharmaceutical Development Accelerator |
| title_full_unstemmed | Scale-Agnostic Models Based on Dimensionless Quality by Design as Pharmaceutical Development Accelerator |
| title_short | Scale-Agnostic Models Based on Dimensionless Quality by Design as Pharmaceutical Development Accelerator |
| title_sort | scale agnostic models based on dimensionless quality by design as pharmaceutical development accelerator |
| topic | Quality by Design design space Pi–Buckingham dimensional analysis design of experiments pharmaceutical process development |
| url | https://www.mdpi.com/1424-8247/18/7/1033 |
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