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The establishment of appropriate bioequivalence (BE) approaches for locally acting gastrointestinal drugs has been a challenging issue. This article introduces available approaches for BE studies, and further, taking specific drugs as examples, discusses general considerations for BE approaches for generic solid oral drug products acting locally within gastrointestinal tract, based on technical requirements and studies carried out for generic drugs in China, as well as referring to experiences of advanced regulatory agencies.

, authors=Fang YAN, Chong YAO, Ke-zhan WANG, Xiao SONG, Jun WANG, authorsList=Fang YAN, Chong YAO, Ke-zhan WANG, Xiao SONG, Jun WANG, authorCompany=null, correspAuthors=Jun WANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1292130449434894904, articleId=1292130449011270198, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=胃肠道局部作用口服固体制剂生物等效性研究方法的一般考虑, columnId=1246531408819278046, journalTitle=中国临床药理学杂志, columnName=综述, runingTitle=null, highlight=null, articleAbstract=

建立适合胃肠道局部作用药物的生物等效性（BE）研究方法一直存在诸多挑战。本文基于我国技术要求和仿制药研究情况，同时参考国际先进监管机构经验，介绍BE研究的常用方法，并进一步结合典型药物，探讨胃肠道局部作用口服固体制剂仿制药BE研究方法的一般考虑。

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闫方（1985-），男，副研究员，主要从事药品注册申请的临床药理学和生物等效性研究技术审评工作

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闫方（1985-），男，副研究员，主要从事药品注册申请的临床药理学和生物等效性研究技术审评工作

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