Show simple item record

dc.creatorĐuriš, Jelena
dc.creatorĐurić, Zorica
dc.date.accessioned2019-09-02T11:59:31Z
dc.date.available2019-09-02T11:59:31Z
dc.date.issued2017
dc.identifier.issn0378-5173
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/2884
dc.description.abstractMathematical models can be used as an integral part of the quality by design (QbD) concept throughout the product lifecycle for variety of purposes, including appointment of the design space and control strategy, continual improvement and risk assessment. Examples of different mathematical modeling techniques (mechanistic, empirical and hybrid) in the pharmaceutical development and process monitoring or control are provided in the presented review. In the QbD context, mathematical models are predominantly used to support design space and/or control strategies. Considering their impact to the final product quality, models can be divided into the following categories: high, medium and low impact models. Although there are regulatory guidelines on the topic of modeling applications, review of QbDbased submission containing modeling elements revealed concerns regarding the scale-dependency of design spaces and verification of models predictions at commercial scale of manufacturing, especially regarding real-time release (RTR) models. Authors provide critical overview on the good modeling practices and introduce concepts of multiple-unit, adaptive and dynamic design space, multivariate specifications and methods for process uncertainty analysis. RTR specification with mathematical model and different approaches to multivariate statistical process control supporting process analytical technologies are also presented.en
dc.publisherElsevier Science BV, Amsterdam
dc.relationinfo:eu-repo/grantAgreement/MESTD/Technological Development (TD or TR)/34007/RS//
dc.rightsrestrictedAccess
dc.sourceInternational Journal of Pharmaceutics
dc.subjectQuality by designen
dc.subjectMathematical modelingen
dc.subjectDesign spaceen
dc.subjectControl strategyen
dc.subjectPharmaceutical manufacturingen
dc.subjectReal-time releaseen
dc.titleModeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointmenten
dc.typearticle
dc.rights.licenseARR
dcterms.abstractЂурић, Зорица; Ђуриш, Јелена;
dc.citation.volume533
dc.citation.issue2
dc.citation.spage346
dc.citation.epage356
dc.citation.other533(2): 346-356
dc.citation.rankM21
dc.identifier.wos000414188500004
dc.identifier.doi10.1016/j.ijpharm.2017.05.070
dc.identifier.pmid28579542
dc.identifier.scopus2-s2.0-85020452915
dc.identifier.rcubconv_3980
dc.type.versionpublishedVersion


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record