The quality of drugs is the basis of their efficacy and safety,thus is closely related to the therapeutic outcome and life and health of patients,having especially important clinical significance.The purpose of drug quality evaluation is mainly to learn the general quality situation of a certain drug or compare the qualities of drugs with the same genetic name manufactured by different companies,thus to provide reference for medical institutions to select pharmaceutical products or update formulary and also for relevant authorities to make decisions.There are three methods to conduct drug quality evaluation:literature review,laboratory experiment,and the combination of literature review and laboratory experiment.This chapter introduces the contents and methods of drug quality evaluation from the perspectives of quality level,quality standard,post-marketing quality supervision and assessment,key evaluation items for drugs of specific classes or dosage forms,package insert,labeling,package,etc.,and proposes the technical route of drug quality evaluation,aiming to provide some ideas for professionals to conduct quality evaluation of chemical drugs and biological products.
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