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dc.creatorSavić, Ivan
dc.creatorMarinković, Valentina
dc.creatorTasić, Ljiljana
dc.creatorKrajnović, Dušanka
dc.creatorSavić, Ivana
dc.date.accessioned2019-09-02T11:28:20Z
dc.date.available2019-09-02T11:28:20Z
dc.date.issued2012
dc.identifier.issn0949-1775
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/1676
dc.description.abstractQuality by design (QbD) is a concept first outlined by Juran, who believed that quality could be planned and that most quality crises and problems relate to the way in which quality was planned in the first place. Experimental design is a powerful technique and tool for QbD, used for exploring new processes, gaining increased knowledge of the existing processes and optimizing these processes for achieving internationally competitive performance. It is also used for the investigation of relationship between parameters of ill-defined process. In this paper, the experimental design principles in pharmaceutical development and impact of these principles on pharmaceutical legislation have been reviewed. Also, slow implementation of QbD in pharmaceutical industries has been discussed. Pharmaceutical legislation is necessary for companies to continue benefiting from knowledge gained and to continually improve throughout the process lifecycle by making adaptations to assure that root causes of manufacturing problems are quickly corrected.en
dc.publisherSpringer, New York
dc.relationinfo:eu-repo/grantAgreement/MESTD/Technological Development (TD or TR)/34012/RS//
dc.rightsrestrictedAccess
dc.sourceAccreditation and Quality Assurance
dc.subjectQuality by designen
dc.subjectExperimental designen
dc.subjectPharmaceutical quality systemen
dc.subjectPharmaceutical legislationen
dc.titleFrom experimental design to quality by design in pharmaceutical legislationen
dc.typearticle
dc.rights.licenseARR
dcterms.abstractСавић, Иван М.; Савић, Ивана М.; Тасић, Љиљана; Маринковић, Валентина; Крајновић, Душанка;
dc.citation.volume17
dc.citation.issue6
dc.citation.spage627
dc.citation.epage633
dc.citation.other17(6): 627-633
dc.citation.rankM22
dc.identifier.wos000311199500008
dc.identifier.doi10.1007/s00769-012-0926-y
dc.identifier.scopus2-s2.0-84873266851
dc.identifier.rcubconv_2725
dc.type.versionpublishedVersion


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