Biowaiver monographs for immediate release solid oral dosage forms: Prednisolone
Identifieur interne : 001B78 ( Main/Exploration ); précédent : 001B77; suivant : 001B79Biowaiver monographs for immediate release solid oral dosage forms: Prednisolone
Auteurs : M. Vogt [Allemagne] ; H. Derendorf [États-Unis] ; J. Kr Mer [Allemagne] ; H. E. Junginger [Thaïlande] ; K. K. Midha [Canada] ; V. P. Shah [Pays-Bas] ; S. Stavchansky [États-Unis] ; J. B. Dressman [Allemagne] ; D. M. Barends [Pays-Bas]Source :
- Journal of Pharmaceutical Sciences [ 0022-3549 ] ; 2007-01.
English descriptors
- Teeft :
- Barends, Bioavailability, Bioequivalence, Biopharmaceutics system, Biowaiver, Biowaiver monograph, Biowaiver monographs, Clin, Clin endocrinol metab, Clin pharmacol, Corticosteroid, Dos, Dosage, Dosage forms, Drug products, Essential medicines, Excipients, False biowaiver decision, Frey, High doses, Immediate release, January, Junginger, Literature data, Monograph, Oral absorption, Oral dosage forms, Permeability, Pharm, Pharmaceutical, Pharmaceutical sciences, Pharmacokinetics, Pharmacol, Prednisolon, Prednisolone, Prednisolone disposition, Prednisolone tablets, Prednisone, Public health, Reference formulation, Reference product, Solubility, Tabletten, Test formulation, Test product, Vivo bioequivalence.
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. © 2006 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 96:27–37, 2007
Url:
DOI: 10.1002/jps.20768
Affiliations:
- Allemagne, Canada, Pays-Bas, Thaïlande, États-Unis
- District de Darmstadt, Floride, Hesse (Land), Hollande-Méridionale, Texas
- Francfort-sur-le-Main, La Haye
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Le document en format XML
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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. © 2006 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 96:27–37, 2007</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Canada</li><li>Pays-Bas</li><li>Thaïlande</li><li>États-Unis</li></country><region><li>District de Darmstadt</li><li>Floride</li><li>Hesse (Land)</li><li>Hollande-Méridionale</li><li>Texas</li></region><settlement><li>Francfort-sur-le-Main</li><li>La Haye</li></settlement></list><tree><country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Vogt, M" sort="Vogt, M" uniqKey="Vogt M" first="M." last="Vogt">M. Vogt</name></region><name sortKey="Dressman, J B" sort="Dressman, J B" uniqKey="Dressman J" first="J. B." last="Dressman">J. B. Dressman</name><name sortKey="Kr Mer, J" sort="Kr Mer, J" uniqKey="Kr Mer J" first="J." last="Kr Mer">J. Kr Mer</name></country><country name="États-Unis"><region name="Floride"><name sortKey="Derendorf, H" sort="Derendorf, H" uniqKey="Derendorf H" first="H." last="Derendorf">H. Derendorf</name></region><name sortKey="Stavchansky, S" sort="Stavchansky, S" uniqKey="Stavchansky S" first="S." last="Stavchansky">S. Stavchansky</name></country><country name="Thaïlande"><noRegion><name sortKey="Junginger, H E" sort="Junginger, H E" uniqKey="Junginger H" first="H. E." last="Junginger">H. E. Junginger</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Midha, K K" sort="Midha, K K" uniqKey="Midha K" first="K. K." last="Midha">K. K. Midha</name></noRegion></country><country name="Pays-Bas"><region name="Hollande-Méridionale"><name sortKey="Shah, V P" sort="Shah, V P" uniqKey="Shah V" first="V. P." last="Shah">V. P. 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