Приказ основних података о документу

dc.creatorHomšek, Irena
dc.creatorParojčić, Jelena
dc.creatorDacević, Mirjana
dc.creatorPetrović, Ljiljana
dc.creatorJovanović, Dušan
dc.date.accessioned2019-09-02T11:21:53Z
dc.date.available2019-09-02T11:21:53Z
dc.date.issued2010
dc.identifier.issn0004-4172
dc.identifier.urihttps://farfar.pharmacy.bg.ac.rs/handle/123456789/1404
dc.description.abstractThe Biopharmaceutics Classification System (BCS) represents the framework for predicting the intestinal drug absorption based on its solubility and intestinal permeability. Recent research has lead to the use of in vitro tests to waive additional in vivo bioequivalence studies for some pharmaceutical products (i.e. biowaiver). The current regulations permit waivers for BCS Class I (highly soluble/highly permeable) drug substances, which represent up to 25% of the drugs. Efforts in both the science and regulatory bodies are being made to extend biowaivers to certain Class II and III products, which would represent more than 50% of all drugs coming to the market. The aim of this study was to investigate the influence of experimental conditions on metformin hydrochloride (CAS 1115-70-4) release from two immediate-release tablet formulations with proven bioequivalence and justify the biowaiver request for dissolution profile similarity in three pH media. The results obtained indicate that differences in drug dissolution observed in vitro were not reflected in vivo. Such data support the existing idea that BCS Class III drugs are eligible biowaiver candidates, even if a very rapid dissolution criterion is not fulfilled.en
dc.publisherECV-Editio Cantor Verlag Medizin Naturwissenschaften, Aulendorf
dc.relationinfo:eu-repo/grantAgreement/MESTD/MPN2006-2010/23015/RS//
dc.rightsrestrictedAccess
dc.sourceArzneimittelforschung - Drug Research
dc.subjectAntihyperglycemic drugen
dc.subjectBCS Class III drugsen
dc.subjectCAS 1115-70-4en
dc.subjectIn vitro - in vivo correlationen
dc.subjectMetformin hydrochlorideen
dc.subjectbioequivalenceen
dc.subjectdissolutionen
dc.subjectimmediate-releaseen
dc.titleJustification of metformin hydrochloride biowaiver criteria based on bioequivalence studyen
dc.typearticle
dc.rights.licenseARR
dcterms.abstractПаројчић, Јелена; Хомшек, Ирена; Јовановић, Душан; Петровић, Љиљана; Дацевић, Мирјана;
dc.citation.volume60
dc.citation.issue9
dc.citation.spage553
dc.citation.epage559
dc.citation.other60(9): 553-559
dc.citation.rankM23
dc.identifier.wos000282502000003
dc.identifier.doi10.1055/s-0031-1296324
dc.identifier.pmid21117498
dc.identifier.scopus2-s2.0-77957721967
dc.identifier.rcubhttps://hdl.handle.net/21.15107/rcub_farfar_1404
dc.type.versionpublishedVersion


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