Show simple item record

Biowaiver monographs for immediate release solid oral dosage forms: Amitriptyline hydrochloride This paper reflects the scientific opinion of the authors and not the policies of regulating agencies.

dc.contributor.authorManzo, R. H.en_US
dc.contributor.authorOlivera, M. E.en_US
dc.contributor.authorAmidon, Gordon L.en_US
dc.contributor.authorShah, V. P.en_US
dc.contributor.authorDressman, Jennifer B.en_US
dc.contributor.authorBarends, D. M.en_US
dc.date.accessioned2007-05-02T14:14:42Z
dc.date.available2007-05-02T14:14:42Z
dc.date.issued2006-05en_US
dc.identifier.citationManzo, R.H.; Olivera, M.E.; Amidon, G.L.; Shah, V.P.; Dressman, J.B.; Barends, D.M. (2006). "Biowaiver monographs for immediate release solid oral dosage forms: Amitriptyline hydrochloride This paper reflects the scientific opinion of the authors and not the policies of regulating agencies. ." Journal of Pharmaceutical Sciences 95(5): 966-973. <http://hdl.handle.net/2027.42/50637>en_US
dc.identifier.issn0022-3549en_US
dc.identifier.issn1520-6017en_US
dc.identifier.urihttps://hdl.handle.net/2027.42/50637
dc.identifier.urihttp://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=16557529&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 amitriptyline hydrochloride are reviewed. Its therapeutic uses, its pharmacokinetic properties, the possibility of excipient interactions and reported BE/bioavailability (BA) problems are also taken into consideration. Literature data indicates that amitriptyline hydrochloride is a highly permeable active pharmaceutical ingredient (API). Data on the solubility according to the current Biopharmaceutics Classification System (BCS) were not fully available and consequently amitriptyline hydrochloride could not be definitively assigned to either BCS Class I or BCS Class II. But all evidence taken together, a biowaiver can currently be recommended provided that IR tablets are formulated with excipients used in existing approved products and that the dissolution meets the criteria defined in the Guidances. © 2006 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 95:966–973, 2006en_US
dc.format.extent122610 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: Amitriptyline hydrochloride 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.affiliationotherPharmacy Department, Chemical Sciences Faculty, National University of CÓrdoba, CÓrdoba, Argentinaen_US
dc.contributor.affiliationotherPharmacy Department, Chemical Sciences Faculty, National University of CÓrdoba, CÓrdoba, Argentinaen_US
dc.contributor.affiliationotherInternational Pharmaceutical Federation FIP, Den Haag, The Netherlandsen_US
dc.contributor.affiliationotherDepartment of Pharmaceutical Technology, Johann Wolfgang Goethe-University, Frankfurt am Main, Germanyen_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.pmid16557529en_US
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/50637/1/20615_ftp.pdfen_US
dc.identifier.doihttp://dx.doi.org/10.1002/jps.20615en_US
dc.identifier.sourceJournal of Pharmaceutical Sciencesen_US
dc.owningcollnameInterdisciplinary and Peer-Reviewed


Files in this item

Show simple item record

Accessibility: If you are unable to use this file in its current format, please select the Contact Us link and we can modify it to make it more accessible to you.