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Quality-by-design as the pharmaceutical innovation paradigm: mapping the field and proposing a conceptual framework

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Quality management (QM) and innovation practices are essential for business competitiveness, yet they often conflict when striving for radical advancements within complex innovation ecosystems. Amid this debate, the concept of Quality-by-Design (QbD) remains underexplored in management literature, despite its extensive development in technical fields. Taking the case of QbD in the pharmaceutical sector, this study aims at researching into its relationship with innovation, considering the interactions within the innovation ecosystem. We perform a bibliometric study, a selective content analysis combined with an assessment of the regulatory framework and relevant examples from the industry.

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Technological Forecasting and Social Change, 2025, vol. 217

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Articles publicats en revistes (Empresa)

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Quality-by-design as the pharmaceutical innovation paradigm: mapping the field and proposing a conceptual framework