Study on requirements of bioequivalence for registration of pharmaceutical products in USA Europe and Canada

摘要

The present study was aimed to study the requirements of bioequivalence for the registration of pharmaceutical products in the USA, Europe and Canada. Before going into bioequivalence studies it is essential for the pharmaceutical industry to study the guidelines of bioequivalence for the respective country where the industry wants to market its products and thus enter into generic market. This study reviews the requirements of bioequivalence with study parameters such as study design, fasting or fed state studies, volunteers recruitment, study dose, sampling points, analytical method validation parameters, moieties to be measured in plasma, pharmacokinetic parameters, criteria for bioequivalence, GCP requirements etc, which are needed for the pharmaceutical industry to carry out bioequivalence studies and to file ANDA. Test products and reference products are needed for this study. Test products are usually manufactured by a sponsor and reference products are provided by the government laboratories of the respective countries. Sampling points also vary with respect to the regulatory guidelines of these countries. All these countries follow ICH GCP guidelines. The criterion of bioequivalence for these countries is 90% CI 80–125% for Cmax, AUCt, AUC0–∞.