Article(id=1322127308006215737, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127297054888908, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1635177600000, acceptedDateStr=2021-10-26, onlineDate=1793149314166, onlineDateStr=2026-10-28, pubDate=1639497600000, pubDateStr=2021-12-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793149314166, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793149314166, creator=13701087609, updateTime=1793149314166, updator=13701087609, issue=Issue{id=1322127297054888908, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='23', pageStart='2121', pageEnd='2224', issueExtLink='null', onlineDate='null', pubDate='1639497600000', pubDateStr='2021-12-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793149311555, creator='13701087609', updateTime=1793149538282, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322128248071369266, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127297054888908, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322128248075563571, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127297054888908, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2147, endPage=2152, ext={EN=ArticleExt(id=1322127308203348026, articleId=1322127308006215737, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Interpretation of “Guidance on Pharmaceutical Development of Paediatric Medicines”, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

“Guidance on Pharmaceutical Development of Paediatric Medicines” was issued by National Medical Products Administration on December 2020, aiming to encourage and facilitate the development and accessibility of paediatric medicines. This paper provides a detailed interpretation of the guidance, combined with the drafting process of the guidance and the current state of the pharmaceutical development level in China. The paper is intended to help applicants getting a better understanding of the scientific and technical requirements for pharmaceutical development of paediatric medicines.

, authors=Juan LIU, Lian-jie REN, authorsList=Juan LIU, Lian-jie REN, authorCompany=null, correspAuthors=Lian-jie REN, 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=1322127308459200571, articleId=1322127308006215737, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=《儿童用药（化学药品）药学开发指导原则（试行）》解读, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

为鼓励和促进国内制药企业对于儿童用药品的开发，满足儿童用药需求，国家药品监督管理局于2020年12月正式发布了《儿童用药（化学药品）药学开发指导原则（试行）》。本文结合该指南的起草过程以及我国儿童用药品研发现状，对指南进行详细解读，以方便开发者在儿童用药的药学开发过程中更好地理解相关技术要求，促进儿童用药的开发。

, authors=刘涓, 任连杰, authorsList=刘涓, 任连杰, authorCompany=null, correspAuthors=任连杰, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=0201GryMmr+GAtaZUEghDw==, magXml=ONR1B+Ausv28RabE6LJ6FA==, pdfUrl=null, pdf=axym4qaNvp99FXq3VRHJ5w==, pdfFileSize=2900681, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=KD8seRsPzkXUoQkIQTnqdw==, mapNumber=null, fund=null)}, authors=[Author(id=1322127308845076544, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322127308006215737, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=liuj@cde.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322127308949934146, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322127308006215737, authorId=1322127308845076544, language=EN, stringName=Juan LIU, firstName=Juan, middleName=null, lastName=LIU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322127309046403139, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322127308006215737, authorId=1322127308845076544, language=CN, stringName=刘涓, 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　100022, bio={"content":"

刘涓，女，主管药师，主要从事化学药品技术审评工作。联系电话：（010）85242866，E-mail：liuj@cde.org.cn。

"}, bioImg=null, bioContent=

刘涓，女，主管药师，主要从事化学药品技术审评工作。联系电话：（010）85242866，E-mail：liuj@cde.org.cn。

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