Subject Selection and Management in Bioequtvalence Studies

Abstract

This article summarizes the criteria for selection of subjects to participate in bioequivalence studies and the management of these subjects while the study is in progress. Factors such as gender, age, body size, nutritional status, tobacco use, disease states, concurrent drug use, and substance abuse must be considered to identify a suitable subject population in which the product formulations, and not intersubject variations, will be the only significant determinants of bioequivalence. Fluid and food intake, physical activity, and consumption of certain dietary products must be carefully restricted during the study course so that these factors will not influence drug absorption or elimination.