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Biowaiver monographs for immediate release solid oral dosage forms: prednisolone.
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|Title: ||Biowaiver monographs for immediate release solid oral dosage forms: prednisolone.|
|Citation: ||J Pharm Sci 2007, 96(1):27-37|
|Issue Date: ||1-Jan-2007 |
|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.|
|Appears in Collections: ||Miscellaneous|
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Biowaiver monographs for immediate release solid oral dosage forms: isoniazid.
Becker C, Dressman JB, Amidon GL, Junginger HE, Kopp S, Midha KK, Shah VP, Stavchansky S, Barends DM, International Pharmaceutical Federation, Groupe BCS
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