Article(id=1291704959783953332, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.19.023, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1739980800000, receivedDateStr=2025-02-20, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896061130, onlineDateStr=2026-08-05, pubDate=1760630400000, pubDateStr=2025-10-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896061130, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896061130, creator=13701087609, updateTime=1785896061130, updator=13701087609, issue=Issue{id=1291704892859638107, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='19', pageStart='2701', pageEnd='2850', issueExtLink='null', onlineDate='null', pubDate='1760630400000', pubDateStr='2025-10-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896045171, creator='13701087609', updateTime=1785896787712, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291708007352656266, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291708007352656267, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2844, endPage=2850, ext={EN=ArticleExt(id=1291704960027222966, articleId=1291704959783953332, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Best practices for flow cytometry-based bioanalytical methods and sample testing in registration clinical trials (2025 edition), columnId=1291704959951725493, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Expert Consensus, runingTitle=null, highlight=null, articleAbstract=

Flow cytometry (FCM), due to its high-throughput, multi-parametric and precise analytical capabilities, has become an indispensable tool in clinical research, diagnosis and treatment monitoring. In recent years, with the rapid development of new biotechnologies and emerging cell and gene therapy drugs, the importance of some key endpoints measured by flow cytometry in registered clinical studies has become even more prominent. Therefore, an expert consensus and best practice of the flow cytometry validation in the industry is urgently needed. The method validation of flow cytometry is to ensure reliable, accurate and reproducible results in scientific research and clinical applications. The validation process demonstrates the suitability of the method under specific application scenarios and experimental requirements by evaluating multiple performance parameters. Based on the complexity and diversity of flow cytometry and the current situation where there are many problems and challenges faced in clinical trials, the Bioanalysis Expert Committee of the Chinese Pharmaceutical Association has organized industry experts to reach a consensus and standards on aspects such as the method development and validation of immunophenotyping, receptor occupancy and pharmacokinetics of cell therapies in clinical studies by flow cytometry, aiming to provide recommendations and references for the scientific and standardized conduct of such studies.

, authors=Hua YANG¹, Ya-ru XU², Fang WANG³, Zhi-yan LI⁴, Duo JIANG⁵, Hong-ting LI⁶, Yan-yu CHEN⁶, Xue ZHANG⁶, Jia-qi LE¹, Jing SHI¹, authorsList=Hua YANG, Ya-ru XU, Fang WANG, Zhi-yan LI, Duo JIANG, Hong-ting LI, Yan-yu CHEN, Xue ZHANG, Jia-qi LE, Jing SHI, 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=1291704960438264760, articleId=1291704959783953332, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=用于注册临床试验中基于流式细胞术的生物分析方法和样品检测的最佳实践（2025版）, columnId=1291704960111109047, journalTitle=中国临床药理学杂志, columnName=专家共识, runingTitle=null, highlight=null, articleAbstract=

流式细胞术（FCM）由于其高通量、多参数和精确的分析能力，已经成为临床研究、诊断和治疗监测中不可或缺的工具。近年来由于新型生物工程技术和细胞基因治疗药物的飞速发展，依赖于流式细胞术的一些关键指标在注册临床研究中的重要性更加突出，临床研究中基于流式细胞术的生物分析方法学验证暂无明确的法规或者指导原则，因此流式细胞术方法学验证也需在行业形成共识和最佳实践。流式细胞术方法学验证是为了确保流式细胞术在科学研究和临床应用中产生可靠、准确和可重复的结果，通过评估多个性能参数来验证该方法在特定应用场景及试验需求下的适用性。基于流式细胞术的复杂多样性以及临床试验中面临较多问题和挑战的现状，由中国药学会医药生物分析专业委员会组织行业专家，就流式细胞术在临床研究中三大主要应用场景：免疫分型、受体占位及细胞治疗类药物的细胞动力学的方法开发和验证等方面达成共识和标准，旨在为此类研究的科学规范开展提供建议和参考。

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杨华（1987-），女，助理研究员，主要从事非临床和临床大分子分析工作

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