WORLD HEALTH ORGANIZATION’S GUIDELINES FOR BIOEQUIVALENCE STUDIES USING PHARMACOKINETIC MEASUREMENTS

Abstract

The purpose of this study is to understand World Health Organization’s guidelines for Bioequivalence studies in humans. It is important for anyone preparing a trial of a medicinal product in humans that the specific aims, problems and risks or benefits of the proposed human study be thoroughly considered and that the chosen design be scientifically sound and ethically justified. All research involving human subjects should be conducted in accordance with the ethical principles, including respect for persons, beneficence (maximize benefits and minimize harms and wrongs) and non- maleficence (do no harm).