仿制药评价逻辑研究  

Research on the evaluation logic of generic drugs

作　　者：陈思 黄哲[1] CHEN Si;HUANG Zhe(School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,Liaoning Provinc,China)

机构地区：[1]沈阳药科大学工商管理学院,辽宁沈阳110016

出　　处：《中国临床药理学杂志》2024年第18期2739-2742,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的分析美国食品药品监督管理局(FDA)发布的仿制药具体产品指南(PSGs),对仿制药评价逻辑进行研究,旨在对我国仿制药评价的思路及技术指南体系的建立提供借鉴。方法通过查询FDA官方网站,汇总截至2022-08-31已发布的2032篇仿制药PSGs,识别具体产品的活性成分名称、剂型、给药途径、推荐的生物等效性(BE)研究要求及研究方法等信息,分析FDA对不同给药途径、不同剂型、不同复杂程度的仿制产品的不同的评价要求。结果与结论本文提出了仿制药的评价逻辑,即仿制药的评价过程为基于产品特性,通过与参比制剂进行科学的比较试验进行风险控制,降低剩余风险至可接受的风险水平的过程。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 2032 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.

关 键 词：仿制药 评价方法 仿制药具体产品指南 生物等效性 评价逻辑 

分 类 号：R97[医药卫生—药品]