SUPAC OF IMMEDIATE-RELEASE, MODIFIED- RELEASE AND SEMI-SOLID: A REGULATORY NOTE
نویسندگان
چکیده
منابع مشابه
Pharmacokinetics and Pharmacodynamics of Gliclazide from Immediate and Modified Release Formulation Tablets in Rats
The objective of the study was to compare pharmacokinetic and pharmacodynamic parameters of gliclazide after administration of immediate (IR) and modified release (MR) tablets. The experiment included rats with both normoglyceamia and streptozocin (STZ)-induced hyperglyceamia. Several MR formulations were designed and in vitro drug release profile was assessed by a dissolution test. For the fur...
متن کاملPharmacokinetics and Pharmacodynamics of Gliclazide from Immediate and Modified Release Formulation Tablets in Rats
The objective of the study was to compare pharmacokinetic and pharmacodynamic parameters of gliclazide after administration of immediate (IR) and modified release (MR) tablets. The experiment included rats with both normoglyceamia and streptozocin (STZ)-induced hyperglyceamia. Several MR formulations were designed and in vitro drug release profile was assessed by a dissolution test. For the fur...
متن کاملpharmacokinetics and pharmacodynamics of gliclazide from immediate and modified release formulation tablets in rats
the objective of the study was to compare pharmacokinetic and pharmacodynamic parameters of gliclazide after administration of immediate (ir) and modified release (mr) tablets. the experiment included rats with both normoglyceamia and streptozocin (stz)-induced hyperglyceamia. several mr formulations were designed and in vitro drug release profile was assessed by a dissolution test. for the fur...
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 ...
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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 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 ...
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ژورنال
عنوان ژورنال: International Journal of Drug Regulatory Affairs
سال: 2018
ISSN: 2321-6794,2321-7162
DOI: 10.22270/ijdra.v2i3.142