对化学药品普通口服固体制剂上市后变更溶出曲线评价的思考  

Consideration on the post approval change evaluation of in vitro dissolution profile for solid oral dosage forms of chemical drugs

作　　者：胡涛 盛燕 钱璟 梁锦锋 HU Tao;SHENG Yan;QIAN Jing;LIANG Jin-feng(Zhejiang Center for Drug&Cosmetic Evaluation,Hangzhou 310012,China)

机构地区：[1]浙江省药品化妆品审评中心,杭州310012

出　　处：《中国新药杂志》2024年第21期2239-2245,共7页Chinese Journal of New Drugs

基　　金：浙江省药品监督管理局科技计划资助项目(2023001)。

摘　　要：药品上市后变更是药品全生命周期管理的重要环节之一,可能给药品质量带来潜在的影响。溶出曲线作为评价化学药品普通口服固体制剂质量的重要指标,可揭示原研制剂与仿制制剂之间的质量一致性,因此越来越受到监管部门和药品研发人员的重视。本文就化学药品普通口服固体制剂上市后变更溶出曲线技术要求进行对比,并分析总结了药品上市后变更溶出曲线评价的若干风险因素,以期对药品上市许可持有人做好化学药品普通口服固体制剂上市后变更研究有所助益。Post approval change is an important part of drug life cycle management,which has potential impact on drug quality.As an important index for evaluating post approval change of oral solid preparations,dissolution curve reveals the quality consistency between the reference listed drug and the generic preparation.Therefore,it has been paid more and more attention by regulatory authorities and drug developers.In this paper,the technical requirements for dissolution curves of oral solid preparations in post approval changes are compared and analyzed,and some risk factors for evaluating dissolution curves of oral solid preparations are analyzed and summarized,in order to help marketing authorization holder to do research on post approval changes of ordinary oral solid preparations.

关 键 词：上市后变更 溶出曲线 口服固体制剂 原研制剂 仿制制剂 

分 类 号：R95[医药卫生—药学]