Editing Bioequivalence (section)

=== United States ===

The FDA considers two products bioequivalent if the 90% CI of the relative mean C<sub>max</sub>, AUC<sub>(0–t)</sub> and AUC<sub>(0–∞)</sub> of the test (e.g. generic formulation) to reference (e.g. innovator brand formulation) should be within 80% to 125% in the fasting state. Although there are a few exceptions, generally a bioequivalent comparison of Test to Reference formulations also requires administration after an appropriate meal at a specified time before taking the drug, a so-called "fed" or "food-effect" study. A food-effect study requires the same statistical evaluation as the fasting study, described above.<ref name="url_www.fda.gov"/>