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

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dc.contributor.authorHernández Vivanco, Alfonso Antonio
dc.contributor.authorVlaisavljevic, Vesna
dc.contributor.authorGonzalez Moragas, Laura
dc.contributor.authorSantana, Mónica
dc.date.accessioned2026-07-31T08:17:21Z
dc.date.embargoEndDateinfo:eu-repo/date/embargoEnd/2028-05-01
dc.date.issued2025-08-01
dc.date.updated2026-07-31T08:17:21Z
dc.description.abstractQuality 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.
dc.embargo.lift2028-05-01
dc.format.extent21 p.
dc.format.mimetypeapplication/pdf
dc.identifier.idgrec759407
dc.identifier.issn0040-1625
dc.identifier.urihttps://hdl.handle.net/2445/231146
dc.language.isoeng
dc.publisherElsevier
dc.relation.isformatofVersió postprint del document publicat a: https://doi.org/10.1016/j.techfore.2025.124182
dc.relation.ispartofTechnological Forecasting and Social Change, 2025, vol. 217
dc.relation.urihttps://doi.org/10.1016/j.techfore.2025.124182
dc.rightscc-by-nc-nd (c) Elsevier, 2025
dc.rights.accessRightsinfo:eu-repo/semantics/embargoedAccess
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceArticles publicats en revistes (Empresa)
dc.subject.classificationControl de qualitat
dc.subject.classificationDisseny industrial
dc.subject.classificationCompetència econòmica
dc.subject.classificationGestió de la innovació
dc.subject.otherQuality control
dc.subject.otherIndustrial design
dc.subject.otherCompetition
dc.subject.otherInnovation management
dc.titleQuality-by-design as the pharmaceutical innovation paradigm: mapping the field and proposing a conceptual framework
dc.typeinfo:eu-repo/semantics/article
dc.typeinfo:eu-repo/semantics/acceptedVersion

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