Quality by design (QbD) for pharmaceutical area

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dc.contributor.authorAksu, Buket
dc.contributor.authorMesut, Burcu
dc.date.accessioned2021-05-15T12:40:39Z
dc.date.available2021-05-15T12:40:39Z
dc.date.issued2015
dc.departmentEczacılık Fakültesien_US
dc.descriptionAksu, Buket/0000-0001-7555-0603;
dc.description.abstractRecent changes and limited resources for drug development and manufacturing have rendered the conventional pharmaceutical quality assurance approach insufficient and have given rise to new research in these areas. To address these research efforts, the FDA improved and modernized the rules governing pharmaceutical manufacturing and product quality in 2002, thereby realizing a paradigm change in the current Good Manufacturing Practices (cGMP). The Quality by Design (QbD) approach has entered the pharmaceutical industry within the last 10 years after the approval of the ICH Q8 in 2005. QbD is based on an understanding of the target product's quality profile (QTPP) and an assessment of its risks during the design and development of pharmaceutical dosage forms. By determining the critical quality attributes of the drug, including its active ingredient, its excipients, and the processes and design spaces used during the R&D phase, multi-way tracking during the life cycle of the drug can be achieved. This tracking can provide numerous advantages, including flexibility in licensing by decreasing the variation and type modifications in applications of the pharmaceutical product, which result from minimizing the possible issues arising after the release of the product. When all these data are observed, it is clear that the new QbD approach benefits the authorities, the drug manufacturers and the patient. Although QbD has certain challenges during its early stages, it is thought that QbD will benefit pharmaceutical manufacturers.en_US
dc.identifier.endpage251en_US
dc.identifier.issn0367-7524
dc.identifier.issn2548-0731
dc.identifier.issue2en_US
dc.identifier.scopus2-s2.0-85022061391
dc.identifier.scopusqualityN/A
dc.identifier.startpage233en_US
dc.identifier.urihttps://hdl.handle.net/20.500.12939/644
dc.identifier.volume45en_US
dc.identifier.wosWOS:000439289200008
dc.identifier.wosqualityN/A
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.institutionauthorAksu, Buket
dc.language.isoen
dc.publisherIstanbul Univ, Fac Pharmacyen_US
dc.relation.ispartofIstanbul Journal of Pharmacy
dc.relation.publicationcategoryDiğeren_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectQuality By Design (QbD)en_US
dc.subjectTarget Product Quality Profileen_US
dc.subjectCritical Quality Attributesen_US
dc.subjectDesign Spaceen_US
dc.subjectRisk Assessmenten_US
dc.titleQuality by design (QbD) for pharmaceutical area
dc.typeReview Article

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