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Dissolution Testing as a Prognostic Tool for Oral Drug Absorption: Immediate Release Dosage Forms

dc.contributor.authorDressman, Jennifer B.en_US
dc.contributor.authorAmidon, Gordon L.en_US
dc.contributor.authorShah, Vinod P.en_US
dc.contributor.authorReppas, Christosen_US
dc.date.accessioned2006-09-08T19:17:04Z
dc.date.available2006-09-08T19:17:04Z
dc.date.issued1998-01en_US
dc.identifier.citationDressman, Jennifer B.; Amidon, Gordon L.; Reppas, Christos; Shah, Vinod P.; (1998). "Dissolution Testing as a Prognostic Tool for Oral Drug Absorption: Immediate Release Dosage Forms." Pharmaceutical Research 15(1): 11-22. <http://hdl.handle.net/2027.42/41462>en_US
dc.identifier.issn1573-904Xen_US
dc.identifier.issn0724-8741en_US
dc.identifier.urihttps://hdl.handle.net/2027.42/41462
dc.identifier.urihttp://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=9487541&dopt=citationen_US
dc.description.abstractDissolution tests are used for many purposes in the pharmaceutical industry: in the development of new products, for quality control and, to assist with the determination of bioequivalence. Recent regulatory developments such as the Biopharmaceutics Classification Scheme have highlighted the importance of dissolution in the regulation of post-approval changes and introduced the possibility of substituting dissolution tests for clinical studies in some cases. Therefore, there is a need to develop dissolution tests that better predict the in vivo performance of drug products. This could be achieved if the conditions in the gastrointestinal tract were successfully reconstructed in vitro . The aims of this article are, first, to clarify under which circumstances dissolution testing can be prognostic for in vivo performance, and second, to present physiological data relevant to the design of dissolution tests, particularly with respect to the composition, volume, flow rates and mixing patterns of the fluids in the gastrointestinal tract. Finally, brief comments are made in regard to the composition of in vitro dissolution media as well as the hydrodynamics and duration of the test.en_US
dc.format.extent1166147 bytes
dc.format.extent3115 bytes
dc.format.mimetypeapplication/pdf
dc.format.mimetypetext/plain
dc.language.isoen_US
dc.publisherKluwer Academic Publishers-Plenum Publishers; Plenum Publishing Corporation ; Springer Science+Business Mediaen_US
dc.subject.otherDissolution Test Conditionsen_US
dc.subject.otherPrediction of in Vivo Performanceen_US
dc.subject.otherBiochemistry, Generalen_US
dc.subject.otherDissolution Testsen_US
dc.subject.otherPharmacology/Toxicologyen_US
dc.subject.otherMedical Lawen_US
dc.subject.otherComposition of Dissolution Mediaen_US
dc.subject.otherBiomedical Engineeringen_US
dc.subject.otherPharmacyen_US
dc.subject.otherBiomedicineen_US
dc.titleDissolution Testing as a Prognostic Tool for Oral Drug Absorption: Immediate Release Dosage Formsen_US
dc.typeArticleen_US
dc.subject.hlbsecondlevelPharmacy and Pharmacologyen_US
dc.subject.hlbtoplevelHealth Sciencesen_US
dc.description.peerreviewedPeer Revieweden_US
dc.contributor.affiliationumCollege of Pharmacy, The University of Michigan, Ann Arbor, Michigan, 48109-1065en_US
dc.contributor.affiliationotherDepartment of Pharmacy, University of Athens, Panepistimiopolis, 157 71, Zografou, Greeceen_US
dc.contributor.affiliationotherOffice of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, HFD-350, Rockville, Maryland, 20857en_US
dc.contributor.affiliationotherInstitut für Pharmazeutische Technologie, Johann Wolfgang Goethe-Universität, Marie-Curie-Str. 9, 60439, Frankfurt am Main, Germanyen_US
dc.contributor.affiliationumcampusAnn Arboren_US
dc.identifier.pmid9487541en_US
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/41462/1/11095_2004_Article_303766.pdfen_US
dc.identifier.doihttp://dx.doi.org/10.1023/A:1011984216775en_US
dc.identifier.sourcePharmaceutical Researchen_US
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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