BIOWAIVER STUDY OF IMMEDIATE RELEASE GLIMEPIRIDE TABLETS
نویسندگان
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 ...
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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: ibuprofen.
Literature data are reviewed on the properties of ibuprofen related to the biopharmaceutics classification system (BCS). Ibuprofen was assessed to be a BCS class II drug. Differences in composition and/or manufacturing procedures were reported to have an effect on the rate, but not the extent of absorption; such differences are likely to be detectable by comparative in vitro dissolution tests. ...
متن کاملBiowaiver monographs for immediate release solid oral dosage forms: lamivudine.
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 lamivudine as the only active pharmaceutical ingredient were reviewed. The solubility and permeability data of lamivudine as well as its therapeutic index, its pharmacokinetic properties, data indicating excipient interac...
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ژورنال
عنوان ژورنال: International Journal of Applied Pharmaceutics
سال: 2021
ISSN: 0975-7058
DOI: 10.22159/ijap.2021v13i1.39383