obtain informed consent from participants approval from institutional ethics committee registration of ethics committees conduct of the clinical trial what should be the labelling practises? how to maintain records of calibration? time interval for calibration responsibility for calibration: purpose of calibration: definition production of mabs in e.coli production by microencapsulation production of monoclonal antibodies by hybridoma difference between mono and polyclonal antibodies introduction of monoclonal antibodies contract research organisation bioequivalence outsourcing bioavailability
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