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dc.contributor.authorVogt, M
dc.contributor.authorDerendorf, H
dc.contributor.authorKrämer, J
dc.contributor.authorJunginger, H E
dc.contributor.authorMidha, K K
dc.contributor.authorShah, V P
dc.contributor.authorStavchansky, S
dc.contributor.authorDressman, J B
dc.contributor.authorBarends, D M
dc.date.accessioned2007-02-15T11:14:46Z
dc.date.available2007-02-15T11:14:46Z
dc.date.issued2007-01-01
dc.identifier.citationJ Pharm Sci 2007, 96(1):27-37en
dc.identifier.issn0022-3549
dc.identifier.pmid17039494
dc.identifier.doi10.1002/jps.20768
dc.identifier.urihttp://hdl.handle.net/10029/8419
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 prednisolone are reviewed. Data on its solubility, oral absorption, and permeability are not totally conclusive, but strongly suggest a BCS Class 1 classification. Prednisolone's therapeutic indications and therapeutic index, pharmacokinetics, and the possibility of excipient interactions were also taken into consideration. Available evidence indicates that a biowaiver for IR solid oral dosage forms formulated with the excipients tabulated in this article would be unlikely to expose patients to undue risks.
dc.format.extent126318 bytes
dc.format.mimetypeapplication/pdf
dc.language.isoenen
dc.titleBiowaiver monographs for immediate release solid oral dosage forms: prednisolone.en
dc.typeArticleen
dc.format.digYES
refterms.dateFOA2018-12-18T15:35:13Z
html.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 prednisolone are reviewed. Data on its solubility, oral absorption, and permeability are not totally conclusive, but strongly suggest a BCS Class 1 classification. Prednisolone's therapeutic indications and therapeutic index, pharmacokinetics, and the possibility of excipient interactions were also taken into consideration. Available evidence indicates that a biowaiver for IR solid oral dosage forms formulated with the excipients tabulated in this article would be unlikely to expose patients to undue risks.


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