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Message: The main aim in conducting a bioequivalence (BE) study is to demonstrate that the active substance in a generic product is absorbed into the body at the same rate and amount as in the comparator/innovator product .This ensures that the generic medicine product delivers the same therapeutic effect as the comparator/innovator product and can be interchangeable without any significant change in the efficacy of the medication.
In line with the Ministry of Health objectives of ensuring quality, efficacy and safety of pharmaceutical products that are marketed, the Drug Control Authority at its 92nd Meeting has decided to review the registration of generic products to include Bioequivalence (BE) studies requirements for certain categories oral immediate release products.
Bioavailability (BA) testing of drug products in humans provides the most appropriate method available for determining bioequivalence. Two drug products are considered bioequivalent if they are pharmaceutically equivalent and their bioavailabilities after administration in the same molar dose are similar to such a degree that their effects, can be expected to be essentially the same.