Article(id=1322245763346845858, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245734427112160, 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=1599753600000, acceptedDateStr=2020-09-11, onlineDate=1793177556120, onlineDateStr=2026-10-28, pubDate=1622304000000, pubDateStr=2021-05-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177556120, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177556120, creator=13701087609, updateTime=1793177556120, updator=13701087609, issue=Issue{id=1322245734427112160, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='10', pageStart='865', pageEnd='960', issueExtLink='null', onlineDate='null', pubDate='1622304000000', pubDateStr='2021-05-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793177549225, creator='13701087609', updateTime=1793177686658, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322246311269740715, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245734427112160, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322246311269740716, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245734427112160, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=886, endPage=892, ext={EN=ArticleExt(id=1322245763527200931, articleId=1322245763346845858, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Considerations for the bioequivalence study of oral antitumor generics, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

This paper takes the guidelines on bioequivalence study in China as the main basis, refers to the relevant requirements of international regulatory agencies, and takes the cytotoxic and small molecule targeted oral antitumor drugs as examples to give some considerations for the study design of bioequivalence of oral antitumor generics from the perspectives of science, ethics and review.

, authors=Fei-fei LIU, Jin-bo YANG, Yu-zhu WANG, authorsList=Fei-fei LIU, Jin-bo YANG, Yu-zhu WANG, authorCompany=null, correspAuthors=Yu-zhu 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=1322245765263642788, articleId=1322245763346845858, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=口服抗肿瘤仿制药生物等效性研究的考虑要点, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

以我国生物等效性研究相关指导原则为主要依据，参考国际监管机构相关要求，旨在从科学、伦理及审评的角度，以细胞毒、小分子靶向类口服抗肿瘤药为例，对口服抗肿瘤仿制药生物等效性研究考虑要点进行综述。

, authors=刘霏霏, 杨进波, 王玉珠, authorsList=刘霏霏, 杨进波, 王玉珠, authorCompany=null, correspAuthors=王玉珠, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=dmhVtgHa7mx4v+oCzMpEsA==, magXml=v2+K8zZrAyouZYGqbUiK5Q==, pdfUrl=null, pdf=FgOJmXvihKU7RENMt6V7mg==, pdfFileSize=1190134, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=amAp8RnFtFe/MxK7Rdimaw==, mapNumber=null, fund=null)}, authors=[Author(id=1322245765485940905, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245763346845858, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=liuff@cde.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322245765548855467, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245763346845858, authorId=1322245765485940905, language=EN, stringName=Fei-fei LIU, firstName=Fei-fei, 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=1322245765620158636, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245763346845858, authorId=1322245765485940905, language=CN, stringName=刘霏霏, 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":"

刘霏霏，女，硕士，审评员，主要从事药品审评工作。联系电话：（010）85243217，E-mail：liuff@cde.org.cn。

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刘霏霏，女，硕士，审评员，主要从事药品审评工作。联系电话：（010）85243217，E-mail：liuff@cde.org.cn。

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