Article(id=1292135489369301167, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135402790482407, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.11.021, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1774972800000, receivedDateStr=2026-04-01, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785998707381, onlineDateStr=2026-08-06, pubDate=1781625600000, pubDateStr=2026-06-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785998707381, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785998707381, creator=13701087609, updateTime=1785998707381, updator=13701087609, issue=Issue{id=1292135402790482407, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='11', pageStart='1501', pageEnd='1650', issueExtLink='null', onlineDate='null', pubDate='1781625600000', pubDateStr='2026-06-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=1, specialIssue=null, createTime=1785998686739, creator='13701087609', updateTime=1786014315540, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292200954833686587, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135402790482407, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292200954833686588, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135402790482407, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1631, endPage=1639, ext={EN=ArticleExt(id=1292135490073944240, articleId=1292135489369301167, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Analysis of pre-marketing and post-marketing clinical pharmacology studies in conditional approvals for oncology drugs in China and the United States, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

Clinical pharmacology research is a crucial component in the evaluation of new drugs, as it effectively reveals the drug’s metabolic processes, mechanisms of action and safety profile. The conditional approval policy typically accelerates the approval process based on limited clinical evidence, which often results in more simplified pre-marketing clinical pharmacology studies, shorter development timelines and smaller sample sizes. Oncology is the therapeutic area with the highest number of conditionally approved drugs, balancing the pre-marketing and post-marketing clinical pharmacology studies requires attention. This paper provides a comparative analysis of the pre-marketing and post-marketing clinical pharmacology studies for conditionally approved oncology drugs by the National Medical Products Administration (NMPA) in China and the U.S. Food and Drug Administration (FDA), highlighting the research patterns for different drug types. The study finds that the FDA generally requires more comprehensive clinical pharmacology studies, particularly in special populations (such as patients with impaired liver or kidney function and pediatric populations) and drug interaction studies, while the NMPA’s requirements are relatively simplified. This paper aims to provide insights for the development of oncology drugs in China and discusses the implementation and requirements of clinical pharmacology studies in the development of new drugs under conditional approval.

, authors=Jing AN¹, Cheng-hao GE², Yang LIU^{2, 3}, Sen LIU³, Chen YIN³, Yi LI⁴, Jing-can WANG⁵, Xiao-yuan CHEN^{2, 3}, authorsList=Jing AN, Cheng-hao GE, Yang LIU, Sen LIU, Chen YIN, Yi LI, Jing-can WANG, Xiao-yuan CHEN, authorCompany=null, correspAuthors=Xiao-yuan CHEN, 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=1292135490598232241, articleId=1292135489369301167, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=中美附条件批准抗肿瘤药物上市前后临床药理学研究的比较分析, 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=

临床药理学研究是新药上市评估的重要环节，能够有效揭示药物在体内的代谢过程、作用机制及安全性特征。附条件批准政策通常基于有限的临床证据进行加速审批，这类药物往往研发周期较短，样本量有限，支持上市的临床证据存在一定不确定性。肿瘤领域是附条件批准药物最多的领域，如何要求附条件批准上市前后的临床药理学研究内容是研发与审评中考虑的重要问题。本文通过对比分析中国国家药品监督管理局（NMPA）和美国食品药品监督管理局（FDA）附条件批准抗肿瘤药物上市前后的临床药理学研究情况，揭示了不同类型药物的研究规律及其差异。研究发现，FDA对附条件批准药物的临床药理学研究要求较为全面，特别是在特殊人群（如肝肾功能不全患者、儿童人群）和药物相互作用等方面，而NMPA的研究要求则相对宽松。本文旨在为中国抗肿瘤药物研发提供参考，探讨临床药理学研究在附条件批准上市的新药研发中的开展情况及要求。

, authors=安静¹, 葛诚浩², 刘洋^{2, 3}, 刘森³, 尹晨³, 李艺⁴, 王婧璨⁵, 陈晓媛^{2, 3}, authorsList=安静, 葛诚浩, 刘洋, 刘森, 尹晨, 李艺, 王婧璨, 陈晓媛, authorCompany=null, correspAuthors=陈晓媛, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=9SCTc5YIim9exi9BGtP7JA==, magXml=bCESGSae+nDpbSPYNA4h5g==, pdfUrl=null, pdf=1dPfOhg7OO/gfdjm58BuNg==, pdfFileSize=4252010, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=ps1sJ1/e/ALHx+SRyT+l7A==, mapNumber=null, fund=null)}, authors=[Author(id=1292135493139980482, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135489369301167, 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=1292135493240643780, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135489369301167, authorId=1292135493139980482, language=EN, stringName=Jing AN, firstName=Jing, middleName=null, lastName=AN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=¹, address=^1.R&G PharmaStudies Co., Ltd, Beijing 100048, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135493311946949, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135489369301167, authorId=1292135493139980482, language=CN, stringName=安静, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=¹, address=^1.诺思格医药科技股份有限公司，北京 100048, bio={"content":"

安静（1986-），女，执业药师，主要从事创新药物及医疗器械的临床试验运营项目管理相关工作

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安静（1986-），女，执业药师，主要从事创新药物及医疗器械的临床试验运营项目管理相关工作

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