Cancer is the second most common cause of death in India (after cardiovascular disease). Cancer burden in India has more than doubled over the last 26 years. Oral Cancer is among the top three cancers in India, number one among all cancers in men and number three among female cancers. Treatment of cancer is limited by affordability of patients in India. Generic drug manufacturers have responded to this scenario by making drugs available at affordable costs, often at less than 10% the cost of the original brand. Bioequivalence (BE) studies are an integral component of the development, approval and marketing of generic drug products globally and are commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities. Keeping in view of this, minor efforts were made to collect the intra/inter subject variability of various anti-cancer drugs, which helps in deciding the appropriate study design and sample size to establish the bioequivalence of generic drug with innovator.
