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dc.creatorĐuriš, Jelena
dc.creatorIbrić, Svetlana
dc.creatorĐurić, Zorica
dc.date.accessioned2019-09-02T11:37:23Z
dc.date.available2019-09-02T11:37:23Z
dc.date.issued2013
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/2034
dc.description.abstractThis first chapter introduces the concept of quality-by-design (QbD) and its role in pharmaceutical product development. QbD assures the quality of a pharmaceutical product through scientific development and risk management tools, and will eventually enable real-time release, regardless of the formulation type. Several guidelines on pharmaceutical development, quality risk management, and pharmaceutical quality systems are presented that are applicable throughout the product lifecycle. Design space appointment and control strategies for risk management are introduced. The meaning of the QbD concept is presented from both regulatory and manufacturers' points of view. Several illustrative examples are provided to facilitate the understanding of the QbD concept and ease of its application.en
dc.publisherElsevier Inc.
dc.rightsrestrictedAccess
dc.sourceComputer-Aided Applications in Pharmaceutical Technology
dc.subjectControl strategiesen
dc.subjectDesign spaceen
dc.subjectQuality-by-design (QbD)en
dc.subjectRisk management toolsen
dc.titleQuality-by-design in pharmaceutical developmenten
dc.typebookPart
dc.rights.licenseARR
dcterms.abstractИбрић, Светлана; Ђурић, Зорица; Ђуриш, Јелена;
dc.citation.spage1
dc.citation.epage16
dc.citation.other: 1-16
dc.identifier.doi10.1016/B978-1-907568-27-5.50001-9
dc.identifier.scopus2-s2.0-84904139815
dc.identifier.rcubconv_4820
dc.type.versionpublishedVersion


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