Bioequivalence Study of Propranolol Tablets

The Ministry of Health is constantly emphasizing the quality, efficacy and safety of pharmaceutical products to safeguard the Malaysians public1. The Drug Control Authority at its 92nd meeting has decided to review the registration of generic products to include bioequivelent studies requirement for certain categories of oral immediate release products2 Bioavailability testing of drug products in humans provides the most appropriate method available for determining bioquivalence. Bioavailability means the rate and extent to which the active substance or therapeutic moiety is absorbed from a pharmaceutical form and becomes available at the site of action. Two medicinal products are bioequivalence if they are pharmaceutical equivalents or alternatives and if their bioavailabilities after administration in the same molar dose are similar to such degree that their effects, with respect to both efficacy and safety, are essentially the same3,4,5. The generic drug preparation that needs this bioequivalent study is the propranolol ORIGINAL ARTICLE