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dc.contributor.authorJantratid, E.en_US
dc.contributor.authorPrakongpan, S.en_US
dc.contributor.authorDressman, J. B.en_US
dc.contributor.authorAmidon, G. L.en_US
dc.contributor.authorJunginger, H. E.en_US
dc.contributor.authorMidha, K. K.en_US
dc.contributor.authorBarends, D. M.en_US
dc.date.accessioned2007-05-02T14:14:35Z
dc.date.available2007-05-02T14:14:35Z
dc.date.issued2006-05en_US
dc.identifier.citationJantratid, E.; Prakongpan, S.; Dressman, J.B.; Amidon, G.L.; Junginger, H.E.; Midha, K.K.; Barends, D.M. (2006). "Biowaiver monographs for immediate release solid oral dosage forms: Cimetidine This paper reflects the scientific opinion of the authors and not the policies of regulating agencies. ." Journal of Pharmaceutical Sciences 95(5): 974-984. <http://hdl.handle.net/2027.42/50636>en_US
dc.identifier.issn0022-3549en_US
dc.identifier.issn1520-6017en_US
dc.identifier.urihttps://hdl.handle.net/2027.42/50636
dc.identifier.urihttp://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=16557528&dopt=citationen_US
dc.description.abstractLiterature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing cimetidine are reviewed. According to the current Biopharmaceutics Classification System (BCS), cimetidine would be assigned to Class III. Cimetidine's therapeutic use and therapeutic index, its pharmacokinetic properties, data related to the possibility of excipient interactions, and reported BE/bioavailability (BA) problems were also taken into consideration. On the basis of the overall evidence, a biowaiver can be recommended for cimetidine IR products, provided that the test product contains only those excipients reported in this paper in their usual amounts, and that the test and the comparator drug products both are “rapidly dissolving” as per BCS. © 2006 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 95:974–984, 2006en_US
dc.format.extent144996 bytes
dc.format.extent3118 bytes
dc.format.mimetypeapplication/pdf
dc.format.mimetypetext/plain
dc.publisherWiley Subscription Services, Inc., A Wiley Companyen_US
dc.subject.otherChemistryen_US
dc.subject.otherFood Science, Agricultural, Medicinal and Pharmaceutical Chemistryen_US
dc.titleBiowaiver monographs for immediate release solid oral dosage forms: Cimetidine This paper reflects the scientific opinion of the authors and not the policies of regulating agencies.en_US
dc.typeArticleen_US
dc.rights.robotsIndexNoFollowen_US
dc.subject.hlbsecondlevelPharmacy and Pharmacologyen_US
dc.subject.hlbtoplevelHealth Sciencesen_US
dc.description.peerreviewedPeer Revieweden_US
dc.contributor.affiliationumCollege of Pharmacy, University of Michigan, Ann Arbor, Michiganen_US
dc.contributor.affiliationotherDepartment of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand ; Institut fÜr Pharmazeutische Technologie, Johann Wolfgang Goethe-UniversitÄt, Frankfurt am Main, Germanyen_US
dc.contributor.affiliationotherDepartment of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailanden_US
dc.contributor.affiliationotherInstitut fÜr Pharmazeutische Technologie, Johann Wolfgang Goethe-UniversitÄt, Frankfurt am Main, Germanyen_US
dc.contributor.affiliationotherLeiden/Amsterdam Center for Drug Research, Leiden University, Division of Pharmaceutical Technology, Leiden, The Netherlandsen_US
dc.contributor.affiliationotherUniversity of Saskatchewan, Saskatoon, Saskatchewan, Canadaen_US
dc.contributor.affiliationotherRIMV, National Institute for Public Health and the Environment, Bilthoven, The Netherlands ; RIMV, National Institute for Public Health and the Environment, Bilthoven, The Netherlands. Telephone: +31 30 2744209; Fax: +31 30 2744462en_US
dc.identifier.pmid16557528en_US
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/50636/1/20614_ftp.pdfen_US
dc.identifier.doihttp://dx.doi.org/10.1002/jps.20614en_US
dc.identifier.sourceJournal of Pharmaceutical Sciencesen_US
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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