Article(id=1322624509853679992, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322624482217415197, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.19.010, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1776700800000, receivedDateStr=2026-04-21, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1793267856323, onlineDateStr=2026-10-29, pubDate=1791993600000, pubDateStr=2026-10-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793267856323, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793267856323, creator=13701087609, updateTime=1793267856323, updator=13701087609, issue=Issue{id=1322624482217415197, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='19', pageStart='2017', pageEnd='2128', issueExtLink='null', onlineDate='null', pubDate='1791993600000', pubDateStr='2026-10-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=1, specialIssue=null, createTime=1793267849735, creator='13701087609', updateTime=1793268229475, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322626075042100008, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322624482217415197, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322626075046294313, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322624482217415197, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2090, endPage=2095, ext={EN=ArticleExt(id=1322624511602704761, articleId=1322624509853679992, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Analysis of the current development status and key points of quality management in clinical trials of nuclear medicine in China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

AbstractIn recent years, the global radiopharmaceutical industry has exhibited a marked trend of rapid growth, playing a pivotal role in the precise diagnosis and treatment of diseases such as oncology, cardiovascular disorders, and neurological conditons, and thus holding extensive application prospects. With the further advancement of precision medicine, clinical trials of radiopharmaceuticals have been increasingly conducted, providing critical evidence for the market approval of more innovative nuclear drugs. However, the quality management of radiopharmaceutical clinical trials present distinct priorities and challenges compared with that of general clinical trials. For example, the short half-life of radionuclides necessitates that investigational radiopharmaceuticals strict adherence to the time window for preparation, quality control, transportation, and administration-any delay at any step may compromise the reliability of trial outcomes. Additionally, radiopharmaceuticals involve unique considerations such as radiation safety, waste disposal, and accurate dose measurement, which impose higher requirements on personnel qualifications, storage and use management of nuclear drugs, radiation protection for participants and healthcare professionals, data traceability, and regulatory compliance. This paper reviews the development of nuclear drug clinical trials and the specific cases of radiopharmaceutical clinical trials conducted at our institution, and summarizes the key points and difficulties in quality control-covering personnel qualifications, nuclear drug management, safety protection, and data management-with the aim of providing useful references for the quality management of nuclear drug clinical trials at various clinical trial institutions.

, authors=Pei-pei SHI, Wei YE, Li-xin HUA, Li-jun TANG, Yi CHAI^*, authorsList=Pei-pei SHI, Wei YE, Li-xin HUA, Li-jun TANG, Yi CHAI, authorCompany=null, correspAuthors=Yi CHAI, 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=1322624511879528826, articleId=1322624509853679992, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=我国核药临床试验的发展现状及质量管理要点分析, columnId=1236331741447778310, journalTitle=中国新药杂志, columnName=药物临床试验规范与进展专栏, runingTitle=null, highlight=null, articleAbstract=

近年来，放射性药品行业在全球范围呈现出显著的快速增长态势，特别在肿瘤、心血管及神经系统等疾病的精准诊断与治疗方面发挥着重要作用，具有广阔的应用前景。随着精准医学理念的深入，放射性药物的临床试验也逐渐增多，为更多创新核药的上市提供了关键证据。然而放射性临床试验的质量管理相较于一般临床试验的管理有不同的侧重点和挑战，例如，放射性核素的短半衰期要求试验用药品必须严格按照时间窗口完成制备、质控、运输和给药，任何环节的延误都可能影响试验结果的可靠性；同时，放射性药物涉及辐照安全、废物处理、剂量精确测量等独特环节，对人员资质、核药存储与使用管理、参与者与医护人员的辐射防护、数据追溯及合规性均提出了更高要求。本文通过梳理核药临床试验的发展及本机构参与过的放射性药物临床试验的具体情况，从人员资质、核药管理、安全防护和数据管理等质控要点与难点方面进行总结，以期对各大药物临床试验机构开展核药临床试验的质量管理提供有益参考。

, authors=侍培培, 叶玮, 华立新, 唐立钧, 柴怡^*, authorsList=侍培培, 叶玮, 华立新, 唐立钧, 柴怡, authorCompany=null, correspAuthors=柴怡, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=4HgfEIMkcJeJrO12ZrEVbw==, magXml=4Z5qQYo28+I7V+1HtdgSMw==, pdfUrl=null, pdf=8+AJhZrD3Gccm26Z30wcPQ==, pdfFileSize=976324, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=d2u/ISsl0lOSRLkjbrTxDg==, mapNumber=null, fund=null)}, authors=[Author(id=1322624513947320703, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=jsphkjspp@163.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322624514035401089, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, authorId=1322624513947320703, language=EN, stringName=Pei-pei SHI, firstName=Pei-pei, middleName=null, lastName=SHI, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322624514136064386, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, authorId=1322624513947320703, language=CN, stringName=侍培培, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=南京医科大学第一附属医院 南京 210029, bio={"content":"

侍培培，女，主管药师，主要从事临床试验质量控制工作。联系电话：(025)68306156，E-mail: jsphkjspp@163.com。

"}, bioImg=null, bioContent=

侍培培，女，主管药师，主要从事临床试验质量控制工作。联系电话：(025)68306156，E-mail: jsphkjspp@163.com。

, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322624512089244027, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, xref=null, ext=[AuthorCompanyExt(id=1322624512097632636, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, companyId=1322624512089244027, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China), AuthorCompanyExt(id=1322624512106021245, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, companyId=1322624512089244027, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=南京医科大学第一附属医院 南京 210029)])]), Author(id=1322624514215756164, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, orderNo=1, 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=1322624514278670726, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, authorId=1322624514215756164, language=EN, stringName=Wei YE, firstName=Wei, middleName=null, lastName=YE, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322624514341585287, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, authorId=1322624514215756164, language=CN, stringName=叶玮, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=南京医科大学第一附属医院 南京 210029, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322624512089244027, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, xref=null, ext=[AuthorCompanyExt(id=1322624512097632636, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, companyId=1322624512089244027, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China), AuthorCompanyExt(id=1322624512106021245, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, companyId=1322624512089244027, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=南京医科大学第一附属医院 南京 210029)])]), Author(id=1322624514408694153, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, orderNo=2, 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=1322624514496774539, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, authorId=1322624514408694153, language=EN, stringName=Li-xin HUA, firstName=Li-xin, middleName=null, lastName=HUA, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322624516153524620, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, authorId=1322624514408694153, language=CN, stringName=华立新, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=南京医科大学第一附属医院 南京 210029, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322624512089244027, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, xref=null, ext=[AuthorCompanyExt(id=1322624512097632636, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, companyId=1322624512089244027, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China), AuthorCompanyExt(id=1322624512106021245, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, companyId=1322624512089244027, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=南京医科大学第一附属医院 南京 210029)])]), Author(id=1322624516249993614, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, orderNo=3, 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=1322624516572955024, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, authorId=1322624516249993614, language=EN, stringName=Li-jun TANG, firstName=Li-jun, middleName=null, lastName=TANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322624516677812625, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, authorId=1322624516249993614, language=CN, stringName=唐立钧, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=南京医科大学第一附属医院 南京 210029, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322624512089244027, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, xref=null, ext=[AuthorCompanyExt(id=1322624512097632636, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, companyId=1322624512089244027, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China), AuthorCompanyExt(id=1322624512106021245, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, companyId=1322624512089244027, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=南京医科大学第一附属医院 南京 210029)])]), Author(id=1322624516757504403, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, orderNo=4, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=littlechaiyi@163.com, emailSecond=null, emailThird=null, correspondingAuthor=1, authorType=1, ext={EN=AuthorExt(id=1322624516963025301, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, authorId=1322624516757504403, language=EN, stringName=Yi CHAI, firstName=Yi, middleName=null, lastName=CHAI, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=^*, address=The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322624517038522774, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, authorId=1322624516757504403, language=CN, stringName=柴怡, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=^*, address=南京医科大学第一附属医院 南京 210029, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322624512089244027, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, xref=null, ext=[AuthorCompanyExt(id=1322624512097632636, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, companyId=1322624512089244027, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China), AuthorCompanyExt(id=1322624512106021245, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, companyId=1322624512089244027, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=南京医科大学第一附属医院 南京 210029)])])], keywords=[Keyword(id=1322624517151768983, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, language=EN, orderNo=1, keyword=radiopharmaceuticals), Keyword(id=1322624517269209496, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, language=EN, orderNo=2, keyword=clinical trial), Keyword(id=1322624517340512665, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, language=EN, orderNo=3, keyword=quality management), Keyword(id=1322624517403427226, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, language=CN, orderNo=1, keyword=核药), Keyword(id=1322624517478924699, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, language=CN, orderNo=2, keyword=临床试验), Keyword(id=1322624517567005084, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, language=CN, orderNo=3, keyword=质量管理)], refs=[Reference(id=1322624521354461600, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［1］, rfOrder=0, authorNames=null, journalName=null, refType=null, unstructuredReference=International Atomic Energy Agency (IAEA). What are Radiopharmaceuticals?.（2024-02-02）[2024-10-10].https://www.iaea.org/newscenter/news/what-areradiopharmaceuticals., articleTitle=null, refAbstract=null), Reference(id=1322624521484485025, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［2］, rfOrder=1, authorNames=null, journalName=null, refType=null, unstructuredReference=傅洁, 刘爽, 王玉坤, 等. 我国放射性药品监管法规体系研究一: 我国放射性药品发展现状及分析[J]. 中国药事, 2025, 39(1): 3-12., articleTitle=null, refAbstract=null), Reference(id=1322624521685811618, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［3］, rfOrder=2, authorNames=null, journalName=null, refType=null, unstructuredReference=张东, 任峰, 牛寒冬, 等. 2018—2023年中美创新药审批趋势及创新性分析[J]. 中国新药杂志, 2025, 34(13): 1373-1383., articleTitle=null, refAbstract=null), Reference(id=1322624521786474915, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［4］, rfOrder=3, authorNames=null, journalName=null, refType=null, unstructuredReference=国家原子能机构, 科技部, 公安部, 等. 医用同位素中长期发展规划（2021—2035年）.（2021-06-25）[2024-07-14].https://www.caea.gov.cn/n6760339/n6760347/c6825911/content.html., articleTitle=null, refAbstract=null), Reference(id=1322624521975218596, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［5］, rfOrder=4, authorNames=null, journalName=null, refType=null, unstructuredReference=黄旭虎, 陈欢, 李可欣, 等. 肿瘤靶向放射性诊疗药物创新研发策略[J]. 原子能科学技术, 2025, 59(4): 769-782., articleTitle=null, refAbstract=null), Reference(id=1322624522067493285, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［6］, rfOrder=5, authorNames=null, journalName=null, refType=null, unstructuredReference=中华人民共和国生态环境部. 核医学辐射防护与安全要求: HJ 1188-2021［S］. 2021., articleTitle=null, refAbstract=null), Reference(id=1322624522155573670, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［7］, rfOrder=6, authorNames=null, journalName=null, refType=null, unstructuredReference=中国疾病预防控制中心辐射防护与核安全医学所, 中国医学科学院放射医学研究所, 广东省职业病防治院. 核医学放射防护要求: GBZ 120-2020［S］. 2020., articleTitle=null, refAbstract=null), Reference(id=1322624522243654055, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［8］, rfOrder=7, authorNames=null, journalName=null, refType=null, unstructuredReference=中国抗癌协会肿瘤核医学专业委员会, 中国医师协会核医学医师分会. ¹⁷⁷Lu-PSMA放射性配体疗法治疗前列腺癌的临床实践专家共识（2024年版）[J]. 中国癌症杂志, 2024, 34(7): 702-714., articleTitle=null, refAbstract=null), Reference(id=1322624522319151528, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［9］, rfOrder=8, authorNames=null, journalName=null, refType=null, unstructuredReference=孙琳. 我国医用同位素产业链分析及展望[J]. 化工管理, 2025, (14): 74-79., articleTitle=null, refAbstract=null), Reference(id=1322624522386260393, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［10］, rfOrder=9, authorNames=null, journalName=null, refType=null, unstructuredReference=胡永兰, 王力, 江凤, 等. 放射性药物临床研究的伦理问题及思考[J]. 中国医学伦理学, 2025, 38(2): 254-260., articleTitle=null, refAbstract=null), Reference(id=1322624522453369258, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［11］, rfOrder=10, authorNames=null, journalName=null, refType=null, unstructuredReference=中国抗癌协会肿瘤核医学专业委员会, 中国医师协会核医学医师分会. ¹⁷⁷Lu-PSMA放射性配体疗法治疗前列腺癌的临床实践专家共识（2024年版）[J]. 中国癌症杂志, 2024, 34(7): 702-714., articleTitle=null, refAbstract=null), Reference(id=1322624522528866731, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［12］, rfOrder=11, authorNames=null, journalName=null, refType=null, unstructuredReference=彭述明, 杨宇川, 杨夏, 等. 反应堆产医用同位素及药物的创新发展研究[J]. 中国工程科学, 2024, 26(2): 224-233., articleTitle=null, refAbstract=null), Reference(id=1322624522604364204, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［13］, rfOrder=12, authorNames=null, journalName=null, refType=null, unstructuredReference=杜进, 黄旭虎, 宋志浩, 等. 中国放射性药物的发展现状及趋势[J]. 原子能科学技术, 2024, 58(S2): 231-240., articleTitle=null, refAbstract=null), Reference(id=1322624522818273709, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［14］, rfOrder=13, authorNames=null, journalName=null, refType=null, unstructuredReference=马伟伟, 张晔, 刘爽, 等. 我国放射性药品监管法规体系研究四: 关于完善我国放射性药品监管法规体系的建议[J]. 中国药事, 2025, 39(1): 34-44., articleTitle=null, refAbstract=null), Reference(id=1322624522939908526, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［15］, rfOrder=14, authorNames=null, journalName=null, refType=null, unstructuredReference=许婧菲, 乔鑫宇, 韦丽雅, 等. 基于国家药品监督管理局审评体系中国放射性药物2019—2025年注册申报趋势分析[J]. 世界临床药物, 2026, 47(4): 441-448., articleTitle=null, refAbstract=null), Reference(id=1322624523023794607, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［16］, rfOrder=15, authorNames=null, journalName=null, refType=null, unstructuredReference=胡永兰, 王力, 江凤, 等. 放射性药物临床研究的伦理问题及思考[J]. 中国医学伦理学, 2025, 38(2): 254-260., articleTitle=null, refAbstract=null), Reference(id=1322624523099292080, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［17］, rfOrder=16, authorNames=null, journalName=null, refType=null, unstructuredReference=中国抗癌协会肿瘤核医学专业委员会, 中国医师协会核医学医师分会. ¹⁷⁷Lu-PSMA放射性配体疗法治疗前列腺癌的临床实践专家共识（2024年版）[J]. 中国癌症杂志, 2024, 34(7): 702-714., articleTitle=null, refAbstract=null), Reference(id=1322624523195761073, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［18］, rfOrder=17, authorNames=null, journalName=null, refType=null, unstructuredReference=赖毓昕, 彭雨萌, 王国昌. 优化标准体系, 规范临床实践: 《医用锗[⁶⁸Ge]/镓[⁶⁸Ga]发生器及镓[⁶⁸Ga]放射性药物质量标准》和《医用镥[¹⁷⁷Lu]及其放射性药物的质量标准》解读[J]. 协和医学杂志, 2025, 16(4): 867-873., articleTitle=null, refAbstract=null), Reference(id=1322624523262869938, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［19］, rfOrder=18, authorNames=null, journalName=null, refType=null, unstructuredReference=MOHAMMED AK, SAADOON SM, ABD ALI ZT, et al. Removal of amoxicillin from contaminated water using modified bentonite as a reactivematerial[J]. Heliyon, 2024, 10(3): 24916., articleTitle=null, refAbstract=null)], funds=[Fund(id=1322624517688639901, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, awardId=2024-AILCZX-07001, language=CN, fundingSource=国家人工智能创新医疗任务揭榜挂帅优胜任务项目：人工智能辅助诊疗医疗器械临床试验中心(2024-AILCZX-07001), fundOrder=null, country=null), Fund(id=1322624517759943070, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, awardId=BM2023004, language=CN, fundingSource=江苏省人工智能医疗器械创新研究与临床试验转化服务中心项目(BM2023004), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1322624512089244027, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, xref=null, ext=[AuthorCompanyExt(id=1322624512097632636, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, companyId=1322624512089244027, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China), AuthorCompanyExt(id=1322624512106021245, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624509853679992, companyId=1322624512089244027, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=南京医科大学第一附属医院 南京 210029)])], figs=null, attaches=null, journal=Journal(id=1235980159023624194, delFlag=0, nameCn=中国新药杂志, nameEn=Chinese Journal of New Drugs, nameHistory1=null, nameHistory2=null, issn=1003-3734, eissn=null, cn=11-2850/R, coden=ZXZHA6, periodic=3, language=CN, oaType=null, ccby=null, superviseOffice=null, ownerOffice=null, pubOffice=null, editorOffice=null, officeType=null, aims=null, clcCode=null, officeProv=null, officeCity=null, officeAddr=null, officeZip=null, officeEmail=null, officePhone=null, editDirector=null, officeDirector=null, officeDirectorPhone=null, officeStaffNum=null, officeEmpNum=null, coverPicUrl=ohPEEN//Vz1tDT3ZBNTp4Q==, journalPrice=null, startedYear=null, abbrevIsoEn=Chinese Journal of New Drugs, journalRemark=null, publicationField=null, createdTime=1772610233314, updatedTime=1788948968376, createdBy=18614031015, updatedBy=13041195026, firstLetterCn=Z, firstLetterEn=Z, subjectCode=Medical and Pharmaceutical Sciences, subjectName=null, subjectCodeEn=Medical and Pharmaceutical Sciences, subjectNameEn=null, picCn=ohPEEN//Vz1tDT3ZBNTp4Q==, picEn=f9WK9bvTM4guTmS/iGhOMg==, jcr=null, cjcr=null, exts=[JournalExt(id=1304509780974924039, language=CN, name=中国新药杂志, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1788948968404, updatedTime=1788948968404, createdBy=13041195026, updatedBy=13041195026, submissionGuidelinesUrl=, submissionAuthorUrl=http://draft.newdrug.cn/journalx_zgxy/authorLogOn.action, submissionEditorUrl=http://draft.newdrug.cn/journalx_zgxy/editorLogOn.action, submissionReviewUrl=http://draft.newdrug.cn/journalx_zgxy/expertLogOn.action, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""}), JournalExt(id=1304509781025255688, language=EN, name=Chinese Journal of New Drugs, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1788948968416, updatedTime=1788948968416, createdBy=13041195026, updatedBy=13041195026, submissionGuidelinesUrl=, submissionAuthorUrl=http://draft.newdrug.cn/journalx_zgxy/authorLogOn.action, submissionEditorUrl=http://draft.newdrug.cn/journalx_zgxy/editorLogOn.action, submissionReviewUrl=http://draft.newdrug.cn/journalx_zgxy/expertLogOn.action, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""})], databaseList=null, tenantJournalId=1235980733773295621, websiteList=[Website(id=1235982099191222761, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1235980733773295621, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/zgxyzz/CN, language=CN, createTime=1772610695884, createBy=18614031015, updateTime=1772610860397, updateBy=18614031015, name=中国新药杂志-中文, tplId=1146099689490845704, title=中国新药杂志, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1235983918629966444, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=articleTextType, value=kx, createTime=1772611129672, updateTime=1772611129672, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918604800617, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=banner, value=null, createTime=1772611129666, updateTime=1772611129666, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918655132271, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=grayFlag, value=0, createTime=1772611129678, updateTime=1772611129678, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918596412008, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=logo, value=https://castjournals.cast.org.cn/joweb/zgxyzz/CN/file/pic?fileId=W567vm71kFC7UhK9TSU6xw==, createTime=1772611129664, updateTime=1772611129664, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918667715185, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=minRunFlag, value=0, createTime=1772611129681, updateTime=1772611129681, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918617383531, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/zgxyzz/CN/file/pic, createTime=1772611129669, updateTime=1772611129669, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918659326576, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=silenceFlag, value=0, createTime=1772611129679, updateTime=1772611129679, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918613189226, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_cn_619/, createTime=1772611129668, updateTime=1772611129668, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918634160749, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=themeColor, value=null, createTime=1772611129673, updateTime=1772611129673, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918646743662, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=themeStyle, value=null, createTime=1772611129676, updateTime=1772611129676, creator=18614031015, updator=18614031015)]), Website(id=1235982099270914542, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1235980733773295621, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/zgxyzz/EN, language=EN, createTime=1772610695903, createBy=18614031015, updateTime=1772610875891, updateBy=18614031015, name=中国新药杂志-英文, tplId=1146101810881728533, title=Chinese Journal of New Drugs, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1235983955829248630, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=articleTextType, value=kx, createTime=1772611138541, updateTime=1772611138541, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955804082803, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=banner, value=null, createTime=1772611138535, updateTime=1772611138535, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955854414457, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=grayFlag, value=0, createTime=1772611138547, updateTime=1772611138547, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955795694194, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=logo, value=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/file/pic?fileId=W567vm71kFC7UhK9TSU6xw==, createTime=1772611138533, updateTime=1772611138533, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955866997371, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=minRunFlag, value=0, createTime=1772611138550, updateTime=1772611138550, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955820860021, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/file/pic, createTime=1772611138539, updateTime=1772611138539, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955862803066, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=silenceFlag, value=0, createTime=1772611138549, updateTime=1772611138549, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955812471412, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_en_623/, createTime=1772611138537, updateTime=1772611138537, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955837637239, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=themeColor, value=null, createTime=1772611138543, updateTime=1772611138543, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955846025848, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=themeStyle, value=null, createTime=1772611138545, updateTime=1772611138545, creator=18614031015, updator=18614031015)])], journalTitle=中国新药杂志, weixinUrl=null, journalUrl=http://www.newdrug.cn/, iacademicId=null, status=1, seqNo=null, journalTitleEn=Chinese Journal of New Drugs, journalPhotoCn=ohPEEN//Vz1tDT3ZBNTp4Q==, journalPhotoEn=f9WK9bvTM4guTmS/iGhOMg==, journalFirstLetter=Z, journalRecommend=null, journalNew=null, journalCollection=null, jcrJf=null, cjcrJf=null, jcrJfStr=null, cjcrJfStr=null, submissionFirstDecision=null, sciSubjectClassification=null, casSubjectClassification=null, citeScore=null, totalCitationFrequency=null, icpCode=null, psCode=null, advertisingLicenseCode=null, copyrightInformation=null, country=null, option=, provinceCode=null, provinceName=null, collectFlag=false, interPubPlatform=, interPubPlatformUrl=null), detailUrlCn=https://castjournals.cast.org.cn/joweb/zgxyzz/CN/10.20251/j.cnki.1003-3734.2026.19.010, detailUrlEn=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/10.20251/j.cnki.1003-3734.2026.19.010, pdfUrlCn=https://castjournals.cast.org.cn/joweb/zgxyzz/CN/PDF/10.20251/j.cnki.1003-3734.2026.19.010, pdfUrlEn=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/PDF/10.20251/j.cnki.1003-3734.2026.19.010, aliStartDate=0, aliEndDate=0, collectionFlag=false, citedCount=null, citedUrl=null, previewStatus=0, delFlag=0, hasFullText=0, orderTime=1791993600000, fullTextJson=null, articleText=null, reference=null)