GENDER INFLUENCE IN DRUG BIOEQUIVALENCE STUDIES

Abstract

Anatomical and physiological differences between the male and female can change the pharmacokinetic process of a drug and thus interfere with its bioavailability, making a particular drug non-bioequivalent when compared in only one gender. The aim of this study was to evaluate the influence of gender on the bioequivalence study of three drug tests in coated tablet form: Methyldopa 500 mg, Diazepam 10 mg and Scopolamine Butylbromide 10 mg. Therefore, the pharmacokinetic parameters that determine the bioequivalence, ASC0-t, ASC0-∞ and Cmax, were recalculated considering the gender separately. The studies of Diazepam and Scopolamine were bioequivalent for both gender but not bioequivalent when considered only women. Methyldopa’s bioequivalence study was not bioequivalent for both sex or for the genders separately. Thus, a more careful evaluation is necessary to analyze and define the bioequivalence of medicines, in order to ensure the efficiency and safety of treatments for both genders.