Abstract
To describe the region wise regulatory guidelines for carrying out biowaiver study in view to possible outcomes in the future along with its importance as major cost saving tool for industry. Bioequivalence is an important parameter in the process of drug development that is performed when there is a change in the formulation of dosage form. The biopharmaceutics classification system (BCS) is a scientific approach for classifying drug substances based on their solubility and intestinal permeability. The bio-relevance of the BCS properties and the in vitro release are best expressed through a correlation between in vitro and in vivo data. It has been estimated for waiving bioequivalence studies on the basis of the solubility and gastrointestinal permeability of drug substance and can be strategically avoided to save time and resources during drug development. A biowaiver has been regarded as an official approval of the waiver for conducting a bioequivalence study in the context of an application for drug approval process. Instead of conducting expensive and time consuming in vivo studies, a dissolution test could be adopted as substitute basis for the decision as to whether the two pharmaceutical products are equivalent. Different regulatory authorities have given guidance for carrying out biowaiver study. The biowaiver approval criteria differ from region wise regulatory authorities. This article mainly outlines in detail aspects regarding biowaiver study and issues with regulatory authorities. BCS based biowaiver have given a lot range to generic industry to reduce cost and resources.