Article(id=1292130374793056828, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130366320562708, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.07.022, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1746460800000, receivedDateStr=2025-05-06, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997487972, onlineDateStr=2026-08-06, pubDate=1776355200000, pubDateStr=2026-04-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997487972, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997487972, creator=13701087609, updateTime=1785997487972, 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=1035, endPage=1040, ext={EN=ArticleExt(id=1292130375241847358, articleId=1292130374793056828, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Discussion on the role of exposure-response analyses in dose selection taking the weight management indication of semaglutide as an example, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

Exposure-response (E-R) analyses aims to evaluate the quantitative relationship between the exposure and response of a drug at different doses. The E-R relationship is one of the core pieces of evidence supporting the assessment of the effectiveness and safety of new drugs, which is of great significance for selecting and optimizing dosage regimens, as well as determining dosing regimens for patients with different physiological, pathological, and genetic backgrounds. In recent years, the research and development of new drugs in China has continued to develop, and long-acting human glucagon-like peptide-1 receptor agonists have become one of the research hotspots. This article takes the weight management indication of semaglutide as an example to discuss the role of E-R analyses in dose selection during the research and development of new drugs, with the aim of promoting related researches in China.

, authors=Fang YAN, Jian LI, Ke-zhan WANG, Jun WANG, authorsList=Fang YAN, Jian LI, Ke-zhan WANG, Jun WANG, authorCompany=null, correspAuthors=Jun 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=1292130375640306239, articleId=1292130374793056828, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=以司美格鲁肽体重管理适应证为例探讨暴露-效应关系分析在剂量选择中的作用, 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=

药物暴露-效应（E-R）关系分析旨在评估药物在不同剂量下的暴露量和效应之间的定量关系。E-R关系是支持新药有效性和安全性评估的核心证据之一，对于选择与优化用法用量，确定不同生理、病理、遗传背景患者的给药方案等均具有十分重要的意义。近年来，国内新药研发持续发展，长效人胰高血糖素样肽-1受体激动剂已成为研发热点之一。本文以司美格鲁肽体重管理适应证为例，探讨E-R关系分析在新药研发剂量选择中的作用，以期对我国相关研究工作有所帮助。

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闫方（1985-），男，副研究员，主要从事药品注册申请的临床药理学和生物等效性研究技术审评工作

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闫方（1985-），男，副研究员，主要从事药品注册申请的临床药理学和生物等效性研究技术审评工作

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