Article(id=1292130463557120934, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130366320562708, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.00.021, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1772035200000, receivedDateStr=2026-02-26, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997509134, onlineDateStr=2026-08-06, pubDate=1776355200000, pubDateStr=2026-04-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997509134, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997509134, creator=13701087609, updateTime=1785997509134, updator=13701087609, issue=Issue{id=1292130366320562708, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='7', pageStart='901', pageEnd='1050', issueExtLink='null', onlineDate='null', pubDate='1776355200000', pubDateStr='2026-04-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785997485952, creator='13701087609', updateTime=1786014433453, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201449350516861, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130366320562708, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201449350516862, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130366320562708, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1030, endPage=1034, ext={EN=ArticleExt(id=1292130464035271591, articleId=1292130463557120934, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical pharmacological research considerations for antisense oligonucleotide drugs, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

As the third-generation therapeutics following small-molecule drugs and biologics, small nucleic acid drugs have become a hotspot in innovative drug research and development due to their strong targeting, unique mechanism of action, and great potential for expanded indications. They have demonstrated significant clinical value in rare diseases, cardiovascular diseases and other therapeutic areas. Antisense oligonucleotide (ASO) drugs, as a major category of small nucleic acid drugs, are driving the overall development of nucleic acid therapeutics. Clinical pharmacology research is a critical step in drug research and translational development, which directly determines the rationality of dosage, safety, and clinical efficacy of drugs. Based on the structural characteristics, mechanism of action, and research and development features of ASO drugs, this paper systematically reviews the key issues in their clinical pharmacology research, providing a reference for improving the efficiency of clinical research and development of ASO drugs in China.

, authors=Rui-rui HE^{1, 2}, Jing WANG^{1, 2}, Shu-jie LIU^{1, 2}, Mei-xia LIU^{1, 2}, Shao-dan LIU^{1, 2}, Chun-min WEI^{1, 2}, Min Li^{1, 2}, authorsList=Rui-rui HE, Jing WANG, Shu-jie LIU, Mei-xia LIU, Shao-dan LIU, Chun-min WEI, Min Li, authorCompany=null, correspAuthors=Min Li, 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=1292130464760886184, articleId=1292130463557120934, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=反义寡核苷酸药物临床药理研究考虑, 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=

小核酸药物作为继小分子化药、生物药后的第三代药物，凭借靶向性强、作用机制独特、适应症拓展潜力大等优势成为创新药研发热点，在罕见病、心血管疾病等领域展现出显著临床价值。反义寡核苷酸（ASO）药物是小核酸药物的重要组成部分，引领核酸药物整体发展。临床药理研究是药物研发转化的关键环节，直接决定药物剂量的合理性、安全性与临床疗效。本文结合ASO药物的结构特征、作用机制及研发特点，系统梳理其临床药理研究中的关键问题，为提升我国ASO药物临床研发效率提供参考。

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贺锐锐（1986-），女，副主任药师，从事临床药理学技术审评的工作

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贺锐锐（1986-），女，副主任药师，从事临床药理学技术审评的工作

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