FDA 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".
Two products are considered bioequivalent if the 90% CI of geometric mean ratios of Cmax, AUCt and AUC∞ of the test (e.g. generic formulation) to reference (e.g. brand formulation) are within 80-125% range under fasting state. Generally a bioequivalent comparison under fed condition (food-effects) is also required and the same statistical evaluation as the fasting study described above is applicable.
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