Examining the basic principles of quality by design (QbD) approach in analytical studies

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dc.contributor.authorMesut, Burcu
dc.contributor.authorÖnal, Cem
dc.contributor.authorAksu, Buket
dc.contributor.authorÖzsoy, Yıldız
dc.date.accessioned2022-08-18T12:59:48Z
dc.date.available2022-08-18T12:59:48Z
dc.date.issued2021en_US
dc.departmentFakülteler, Eczacılık Teknolojisi Bilimleri Bölümü, Farmasötik Teknoloji Ana Bilim Dalıen_US
dc.description.abstractAlthough the first application of Quality by Design (QbD) concept started for product development studies, the number of studies regarding its application to analytical development has been increased recently. Basically, QbD strategy in both formulation development and analytic studies are identical logically and conceptually, but they have somedifferences in terms of its terminology and application. Essential terminology and approach differences in this concept are; the determination of the analytic target profile, critical method characteristics, critical process parameters, and the determination of the method study area. However, the risk evaluation method which is necessary for the appropriate application of quality by design is also an inseparable part of the analytical quality by design. Despite those terminological differences, developing a quality based method with the analytical design that contributes to research with an appropriately applied risk-based design quality approach and provides multiple advantages that will be noticed each and every time, will be useful both for researchers and authorities who investigate license documentation and changes. Therefore, the terminology which is used for analytic quality by design and appropriate risk evaluation approaches are explained in this study.en_US
dc.identifier.citationMesut, B., Önal, C., Aksu, B., Özsoy, Y. (2021). Examining the basic principles of quality by design (QbD) approach in analytical studies. Istanbul Journal of Pharmacy, 51(2), 271 - 276. 10.26650/IstanbulJPharm.2020.0087en_US
dc.identifier.endpage276en_US
dc.identifier.issn2548-0731
dc.identifier.issn2587-2087
dc.identifier.issue2en_US
dc.identifier.startpage271en_US
dc.identifier.trdizinid458844
dc.identifier.urihttps://hdl.handle.net/20.500.12939/2936
dc.identifier.volume51en_US
dc.identifier.wosWOS:000691608500014
dc.identifier.wosqualityN/A
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakTR-Dizin
dc.institutionauthorAksu, Buket
dc.language.isoen
dc.relation.ispartofIstanbul Journal of Pharmacy
dc.relation.isversionof10.26650/IstanbulJPharm.2020.0087en_US
dc.relation.publicationcategoryMakale - Ulusal Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectAnalitycal Quality By Designen_US
dc.subjectRisk Assesmenten_US
dc.subjectProcess Analytical Technologyen_US
dc.subjectAnalytical Target Profileen_US
dc.subjectCritical Quality Atrributesen_US
dc.titleExamining the basic principles of quality by design (QbD) approach in analytical studies
dc.typeArticle

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