Bioequivalencia: ¿Debemos exigirla?

Abstract

From year 2000 an increase in antimicrobial agents selling, mostly generic products is appreciated in the national market. It is important to know not only its pharmaceutical equivalence with trade mark products (equal active principle plus equal dose plus equal formulation) but its bioequivalence, it means its similar clinical effect. There are two forms to measure the bioequivalence: pharmacokinetic studies and clinical therapeutic trials. In this paper it is discussed the methods recommended to establish this bioequivalence and its limitations to accept the pharmaceutical license of generic antimicrobial agents.