**3.3 United States**

In case of FDA, two formulations are bioequivalent if the 90% confidence interval of the relative mean of Cmax, AUC0-t, and AUC0-∞ of the test or generic formulation should be within 80–125% in the fasting state. Sometimes, fed state bioequivalent comparison studies were carried out for test to reference

formulations where required to administer the formulations after an appropriate meal at a specified time before taking the drug to know the food effect. Food effect study requires the same statistical evaluation as the fasting study as described above.
