Bioequivalence studies: need for the reability of generic drugs

Abstract

A generic medicine is a pharmaceutical product containing an active ingredient already known and previously developed and invented by others. The cost of these generic or multisource products should be less than their counterparts original. The clinical effects and the risk-benefit balance of a medicine do not depend exclusively on the activity of a pharmacologically active substance. Demonstration of bioequivalence of generic medicine is of great importance. In Europe and the United States generic medicine approval is based in the demonstration of bioequivalence through comparative bioavailability studies in vivo. These arguments are required for marketing approval of generic medicines by the European and North American health authorities. As a measure of the amount of drug absorbed it is used the area under the curve concentrationtime (AUC), and as an indicator of the rate of absorption it is measured the peak concentration (Cmax) reached in the concentration-time curve and the time for its occurrence (Tmax). It is known as bioequivalence between two products when they have a comparable bioavailability in the appropriate experimental conditions. The ultimate goal of this process is to make quality drugs available to society and contribute to a more rational use of economic resources in the health system.