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KYAMCH Bio Kinetic Center (KBK Center), Studies to establish BE between two products are important for certain changes before approval for a pioneer product in NDA and ANDA submissions and in the presence of certain post approval changes in NDAs and ANDAs. Since the Center focuses on Pharmaceuticals to ensure therapeutic equivalence between a pharmaceutically equivalent test drug product and a reference listed drug, it adheres to validate research / study procedures development, based on GLP guidelines, thus ensuring Quality Assurance. It follows strict comprehensive sets of procedures, ensures internal facility audits and procedural inspection. Controls version, and revision of SOP.
Patient Safety: The center has state-of-the-art bio analytical facility and 12-bedded ward with fully equipped clinical unit, this assures that bioequivalence clinical studies are conducted in a well controlled environment on healthy human subjects. Since it is situated inside the hospital complex, it has access to emergency medical services and ICU, in case the situation requires any emergency medical attention. The center offers separate male female accommodation.