Article(id=1291339025370050810, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291338935477724120, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.01.029, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1711728000000, receivedDateStr=2024-03-30, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785808815567, onlineDateStr=2026-08-04, pubDate=1737043200000, pubDateStr=2025-01-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785808815567, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785808815567, creator=13041195026, updateTime=1785808815567, updator=13041195026, issue=Issue{id=1291338935477724120, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='1', pageStart='1', pageEnd='148', issueExtLink='null', onlineDate='null', pubDate='1737043200000', pubDateStr='2025-01-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785808794022, creator='13041195026', updateTime=1785808794022, updator='13041195026', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=143, endPage=148, ext={EN=ArticleExt(id=1291339025630097660, articleId=1291339025370050810, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Pharmaceutical considerations on novel pharmaceutical preparations in China encourage generic drug catalogue (first to third batches), columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

To meet the domestic clinical demand timely, the national health commission has released three batches of encourage generic drug catalogues, which plays a good guiding role in improving the supply level and accessibility of generic drugs. Based on literature investigation, the typical cases of novel pharmaceutical preparations were analyzed, and the pharmaceutical considerations were put forward in terms formulation, manufacturing process and quality control, aimed to provide scientific reference for research and development of such drugs.

, authors=Xiao-fei SI, Gui-xia SUN, Bao-mei ZHANG, Tian-xing DAI, Yan-xiu GE, Dian-zhuo JIANG, authorsList=Xiao-fei SI, Gui-xia SUN, Bao-mei ZHANG, Tian-xing DAI, Yan-xiu GE, Dian-zhuo JIANG, authorCompany=null, correspAuthors=Dian-zhuo JIANG, 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=1291339027593031934, articleId=1291339025370050810, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=对前3批《鼓励仿制药品目录》中新型药物制剂的药学研究的思考, 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=

为及时满足国内临床用药需求，国家卫生健康委员会等发布了3批《鼓励仿制药品目录》，对完善仿制药保障供应水平，提高用药可及性起到良好的引导作用。本研究通过检索相关国内外审评报告和文献，分析了目录中典型的新型药物制剂，对其药学研究关注的处方工艺和质量控制等进行探讨思考，为仿制药开展相关研究开发提供科学参考依据。

, authors=司晓菲, 孙桂霞, 张保梅, 戴田行, 葛妍秀, 姜典卓, authorsList=司晓菲, 孙桂霞, 张保梅, 戴田行, 葛妍秀, 姜典卓, authorCompany=null, correspAuthors=姜典卓, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=kV6RvWzdiGEbadE/RDct5Q==, magXml=Wp28R7XdUbxy+fR9Xmr7ow==, pdfUrl=null, pdf=enh9pUGxEThqLQ35Buo21Q==, pdfFileSize=1227803, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=xNblq3E0i99QGWmyZMigfg==, mapNumber=null, fund=null)}, authors=[Author(id=1291339027953742083, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339025370050810, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1291339028037628165, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339025370050810, authorId=1291339027953742083, language=EN, stringName=Xiao-fei SI, firstName=Xiao-fei, middleName=null, lastName=SI, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1291339028113125638, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339025370050810, authorId=1291339027953742083, language=CN, stringName=司晓菲, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局 药品审评中心，北京 100076, bio={"content":"

司晓菲（1989-），女，副主任药师，主要从事化学药品技术审评工作

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司晓菲（1989-），女，副主任药师，主要从事化学药品技术审评工作

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