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Bioequivalence If the drug concentration is related to the therapeutic effect, it is assumed that the same subject takes different preparations and then measures the drug concentration in the blood at different time points. If the same blood drug concentration-time curve is obtained, it means that the same effect can be produced at the siteRead more

FDA has defined bioequivalence as “the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.” The purposeRead more