Article(id=1322180289007305493, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180288214577608, 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=1621785600000, acceptedDateStr=2021-05-24, onlineDate=1793161945821, onlineDateStr=2026-10-28, pubDate=1630252800000, pubDateStr=2021-08-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793161945821, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793161945821, creator=13701087609, updateTime=1793161945821, updator=13701087609, issue=Issue{id=1322180288214577608, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='16', pageStart='1441', pageEnd='1536', issueExtLink='null', onlineDate='null', pubDate='1630252800000', pubDateStr='2021-08-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793161945632, creator='13701087609', updateTime=1793162101003, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322180940143644721, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180288214577608, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322180940147839026, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180288214577608, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1456, endPage=1459, ext={EN=ArticleExt(id=1322180289271546646, articleId=1322180289007305493, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Basic considerations for the research and validation of the sterilization process of chemical injections, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

In August 2020, the Center for Drug Evaluation of National Medical Products Administration issued the “Guideline of the research and validation of the terminal sterilization and aseptic process of chemical injections (for trial implementation)”. In this article, based on the draft and revision of the guideline, some important glossaries of the steam sterilization process and decision tree for sterilization choices for chemical injections were clarified, concerns of the research and validation of the steam sterilization process were discussed, and the main points of amendments and the new contents were analyzed and sorted out, in order to provide more references for the follow-up study on consistency evaluation of generic chemical injections.

, authors=Na ZHAO, Jing SHI, Zhen-yu XU, Shan-shan LI, authorsList=Na ZHAO, Jing SHI, Zhen-yu XU, Shan-shan LI, authorCompany=null, correspAuthors=Jing SHI, 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=1322180289590313751, articleId=1322180289007305493, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=化学药品注射剂灭菌工艺研究及验证的基本考虑, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

2020年12月，国家药品监督管理局药品审评中心（以下简称药审中心）公布了《化学药品注射剂灭菌和无菌工艺研究及验证指导原则（试行）》。本文结合该指导原则的起草和修订，对湿热灭菌工艺的重要概念、灭菌工艺选择的决策树进行了阐明，对湿热灭菌工艺研究和验证中的关注点进行了讨论，对修订要点及新增内容进行了分析和梳理，旨在为后续化学药品注射剂仿制药一致性评价的研究提供更多的参考。

, authors=赵娜, 石靖, 许真玉, 李珊珊, authorsList=赵娜, 石靖, 许真玉, 李珊珊, authorCompany=null, correspAuthors=石靖, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=M4BJw/OPxsjRulVTfa9bbQ==, magXml=t8DGxTchSEozmL4U6gdX8A==, pdfUrl=null, pdf=Ofii1YedPWbsIRM4qAPVKQ==, pdfFileSize=1196221, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=oR2vAFj6iMRKBppxUc2Gig==, mapNumber=null, fund=null)}, authors=[Author(id=1322180289913275164, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180289007305493, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=zhaon@cde.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322180290005549854, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180289007305493, authorId=1322180289913275164, language=EN, stringName=Na ZHAO, firstName=Na, middleName=null, lastName=ZHAO, 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=1322180290089435935, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180289007305493, authorId=1322180289913275164, language=CN, stringName=赵娜, 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":"

赵娜，女，硕士研究生，中级工程师，主要从事药物分析研究和化学药品药学审评工作。联系电话：（010）68582602，E-mail：zhaon@cde.org.cn。

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赵娜，女，硕士研究生，中级工程师，主要从事药物分析研究和化学药品药学审评工作。联系电话：（010）68582602，E-mail：zhaon@cde.org.cn。

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