Biowaiver Monographs for Immediate Release Solid OralDosage Forms: Prednisolone
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چکیده
منابع مشابه
Biowaiver monographs for immediate release solid oral dosage forms: isoniazid.
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 isoniazid as the only active pharmaceutical ingredient (API) are reviewed. Isoniazid's solubility and permeability characteristics according to the Biopharmaceutics Classification System (BCS), as well as its therapeutic ...
متن کاملBiowaiver monographs for immediate release solid oral dosage forms: prednisone.
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 prednisone are reviewed. Due to insufficient data prednisone cannot be definitively classified according to the current Biopharmaceutics Classification System (BCS) criteria as both the solubility and the permeability of ...
متن کاملBiowaiver monographs for immediate release solid oral dosage forms: pyrazinamide.
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 pyrazinamide as the only active pharmaceutical ingredient (API) are reviewed. Pyrazinamide is BCS Class III, with linear absorption over a wide dosing range. The risk of bioinequivalence is estimated to be low. Depending ...
متن کاملBiowaiver monographs for immediate release solid oral dosage forms: aciclovir.
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing (biowaiver) for the approval of immediate release (IR) solid oral dosage forms containing aciclovir are reviewed. Aciclovir therapeutic use and therapeutic index, pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability (BA) studies were ...
متن کاملBiowaiver monographs for immediate-release solid oral dosage forms: stavudine.
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 stavudine (d4T) are reviewed. According to Biopharmaceutics Classification System (BCS), d4T can be assigned to BCS class I. No problems with BE of IR d4T formulations containing different excipients and produced by diffe...
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ژورنال
عنوان ژورنال: Journal of Pharmaceutical Sciences
سال: 2007
ISSN: 0022-3549
DOI: 10.1002/jps.20768