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

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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

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Articles publicats en revistes (Farmàcia, Tecnologia Farmacèutica i Fisicoquímica)

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