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Webbased Archive of RIVM Publications > Articles and other publications by RIVM employees > Miscellaneous > Biowaiver monographs for immediate release solid oral dosage forms: prednisolone.


Please use this identifier to cite or link to this item: http://hdl.handle.net/10029/8419
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Title: Biowaiver monographs for immediate release solid oral dosage forms: prednisolone.
Authors: Vogt, M
Derendorf, H
Krämer, J
Junginger, H E
Midha, K K
Shah, V P
Stavchansky, S
Dressman, J B
Barends, D M
Citation: J Pharm Sci 2007, 96(1):27-37
Issue Date: 1-Jan-2007
URI: http://hdl.handle.net/10029/8419
DOI: 10.1002/jps.20768
PubMed ID: 17039494
Abstract: Literature 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.
Type: Article
Language: en
ISSN: 0022-3549
Appears in Collections: Miscellaneous

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