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Bioequivalence: Scientific basis on which generic
and brand-name drugs are compared. To be considered bioequivalent, the bioavailability
of two products must not differ significantly when the two products are
given in studies at the same dosage under similar conditions. Some drugs,
however, are intended to have a different absorption rate. FDA may
consider a product bioequivalent to a second product with a different rate
of absorption if the difference is noted in the labeling and doesn't
affect the drug's safety or effectiveness or change the drug's effects in
any medically significant way.