Objective To analyze the Product-Specific Guidances(PSGs)for generic drugs published by the Food and Drug Administration(FDA),and study the evaluation logic for generic drugs.Methods By querying the official website of the FDA,we collected 2 032 generic PSGs published as of August 31,2022,identified the specific product's active ingredient,dosage forms,administration routes,recommended bioequivalence(BE)research requirements,and research methods,analyzed the FDA's different evaluation requirements for generic products with different administration routes,dosage forms,and complexity levels.Results and Conclusion This article proposed the evaluation logic of Generic Drugs.That is,the evaluation process of generic drugs is based on product characteristics,risk control through scientific comparative tests with reference preparations,and the process of reducing residual risk to an acceptable level.
国家科技期刊平台
NSTL
万方数据
