Article(id=1291339204034814065, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291339021272211834, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.02.029, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1722873600000, receivedDateStr=2024-08-06, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785808858164, onlineDateStr=2026-08-04, pubDate=1737993600000, pubDateStr=2025-01-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785808858164, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785808858164, creator=13041195026, updateTime=1785808858164, updator=13041195026, issue=Issue{id=1291339021272211834, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='2', pageStart='151', pageEnd='300', issueExtLink='null', onlineDate='null', pubDate='1737993600000', pubDateStr='2025-01-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785808814590, creator='13041195026', updateTime=1785808814590, updator='13041195026', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=296, endPage=300, ext={EN=ArticleExt(id=1291339204269695090, articleId=1291339204034814065, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Global regulatory requirement and considerations for pharmaceutical co-crystals, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

As a new solid-state form of drugs, pharmaceutical co-crystals can improve the physicochemical properties of drugs (such as melting point, stability, solubility, hygroscopicity, compressibility, permeability, bioavailability, etc), thereby changing drug performance or enhancing therapeutic efficacy, providing new ideas for drug development. In recent years, pharmaceutical co-crystals has attracted much attention as a hot topic in the research of crystalline drugs, but there is currently no specialized guiding principle for pharmaceutical co-crystals research in China. This article mainly investigates the technical documents on pharmaceutical co-crystals research released by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), elaborates on the regulatory requirements for pharmaceutical co-crystals in foreign countries, compares and analyzes the regulatory requirements of FDA and EMA, in order to provide references for the research and regulation of pharmaceutical co-crystals in China.

, authors=Jing PAN, Xiao-yan WANG, Xiao-long HUANG, authorsList=Jing PAN, Xiao-yan WANG, Xiao-long HUANG, authorCompany=null, correspAuthors=Xiao-long HUANG, 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=1291339204651376755, articleId=1291339204034814065, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=国外药物共晶的监管要求介绍及思考, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=

药物共晶作为一种新的药物固态形式，可改善药物的理化性质（如熔点、稳定性、溶解度、吸湿性、可压性、渗透性和生物利用度等），从而改变药物性能或提高治疗效果，为药物研发提供新的思路。近年来药物共晶作为晶型药物研究热点备受行业关注，而我国目前尚无药物共晶研究的专论指导原则。本文主要通过调研美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）发布的关于药物共晶研究的技术文件，对国外药物共晶的监管要求进行阐述，并对FDA及EMA药物共晶监管要求进行对比分析，以期为我国药物共晶的研发和监管提供借鉴。

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潘静（1991-），女，主管药师，主要从事药品审评的相关工作

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潘静（1991-），女，主管药师，主要从事药品审评的相关工作

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