When an innovative (brand-name) drug is going off patent protection, the innovative drug companies and/or generic drug companies may file an abbreviated new drug application (ANDA) for generic approval through the conduct of a bioequivalence study. Bioequivalence testing for generic approval is based on the Fundamental Bioequivalence Assumption that when two drug products have similar drug absorption profiles (or equivalent in average bioavailability), it is assumed that they will reach similar therapeutic effects or they are therapeutic equivalent. Two drug products are claimed to be bioequivalent if the 90% confidence interval for the geometric mean ratio (GMR) is totally within the bioequivalent limits of (80.00%, 125.00%) based on log-transformed data. For an approved generic drug product, the United States Food and Drug Administration (FDA) indicate that it can be used as a substitute of the brand-name drug.
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