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Abstract
In vitro bioequivalence of carvedilol-containing ‘’Carvidil’’ 6.25 mg tablets (‘’Grindex’’- Latvia) by correlation of reference drug ‘’Dilatrend’’ 6,25mg tablets (‘’Roche’’- Romania) have been studied by test of solubility. Their standardization according to USP was established. They are pharmaceutically equivalent. The kinetics of solubility of active compound carvedilol in 6,25 tablets of ‘’Carvidil’’ and ‘’Dilatrend’’ have been studied by us at pH 1,45, pH 4,5 and pH 6,8. There was not statistically credible difference. The results of our Biowaiver research correspond to the international protocol of validation Guidance for Bioanalitical Method Validation U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation Research (CDER) Center for Veterinary Medicine (CVM) May 2001. The generic drug ‘’Carvidil’’ and reference drug ‘’Dilatrend’’ are equivalent in vitro.
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