obtain informed consent from participantsapproval from institutional ethics committeeregistration of ethics committeesconduct of the clinical trialwhat should be the labelling practises?how to maintain records of calibration?time interval for calibrationresponsibility for calibration:purpose of calibration:definitionproduction of mabs in e.coliproduction by microencapsulationproduction of monoclonal antibodies by hybridomadifference between mono and polyclonal antibodiesintroduction of monoclonal antibodiescontract research organisationbioequivalenceoutsourcing bioavailability
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