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    Biowaiver monographs for immediate release solid oral dosage forms: prednisolone.

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    Authors
    Vogt, M
    Derendorf, H
    Krämer, J
    Junginger, H E
    Midha, K K
    Shah, V P
    Stavchansky, S
    Dressman, J B
    Barends, D M
    Type
    Article
    Language
    en
    
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    Title
    Biowaiver monographs for immediate release solid oral dosage forms: prednisolone.
    Publiekssamenvatting
    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.
    DOI
    10.1002/jps.20768
    PMID
    17039494
    URI
    http://hdl.handle.net/10029/8419
    ae974a485f413a2113503eed53cd6c53
    10.1002/jps.20768
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