ABSTRACT

When two drug products given by the same route containing the same amount of the same drug exhibit in vivo the same rate and extent of absorption, they may be termed bioequivalent. Such products have the same bioavailability and may be expected to produce essentially the same blood concentration-time profiles. Thus, there is good reason to believe that the therapeutic response in patients receiving the two products will be the very similar. The two products may therefore be regarded as therapeutically interchangeable. Bioequivalency is normally quantified by measurement of AUC (area under the plasma concentration-time curve), Tmax (time to maximum plasma concentration), and Cmax (maximum plasma concentration).