Document type

Article

Version

Published version

Publication date

Publication license

cc-by (c)  Romero-Obon, M. et al., 2025
Please use this identifier to cite or link to this item: https://hdl.handle.net/2445/222857

Scale-Agnostic Models Based on Dimensionless Quality by Design as Pharmaceutical Development Accelerator

Journal Title

Director/Tutor

Journal ISSN

Volume Title

Abstract

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. Keywords: Quality by Design; design space; Pi–Buckingham; dimensional analysis; design of experiments; pharmaceutical process development

Citation

Citation

ROMERO OBON, Miquel, et al. Scale-Agnostic Models Based on Dimensionless Quality by Design as Pharmaceutical Development Accelerator. Pharmaceuticals. 2025. Vol. 18, num. 7. ISSN 1424-8247. [consulted: 9 of June of 2026]. Available at: https://hdl.handle.net/2445/222857

Export metadata

JSON - METS

Share record