Article(id=1322245735077237688, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245734427112160, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1609171200000, acceptedDateStr=2020-12-29, onlineDate=1793177549379, onlineDateStr=2026-10-28, pubDate=1622304000000, pubDateStr=2021-05-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177549379, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177549379, creator=13701087609, updateTime=1793177549379, updator=13701087609, issue=Issue{id=1322245734427112160, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='10', pageStart='865', pageEnd='960', issueExtLink='null', onlineDate='null', pubDate='1622304000000', pubDateStr='2021-05-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793177549225, creator='13701087609', updateTime=1793177686658, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322246311269740715, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245734427112160, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322246311269740716, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245734427112160, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=865, endPage=870, ext={EN=ArticleExt(id=1322245735245009849, articleId=1322245735077237688, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=An overview of nonclinical study and evaluation of diagnostic radiopharmaceuticals approved for marketing in the United States in the last two decades, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

In recent years, with the development of radiochemistry, nuclear medicine and molecular biology technology and the interdisciplinary integration, diagnostic radiopharmaceuticals have become a hot field of drug research and development at home and abroad. In the past two decades, the US FDA has approved a number of new diagnostic radiopharmaceuticals for the diagnosis of tumor, cardiovascular disease, Parkinson's syndrome and other diseases. The nonclinical study of drugs is a key part of drug development. This paper sorted out the nonclinical study information of FDA-approved diagnostic radiopharmaceuticals and summarized the focus of nonclinical study and evaluation, aiming to provide information for such drugs' development in China.

, authors=Ai-fang LI, Hong-mei GUANG, Qing-li WANG, authorsList=Ai-fang LI, Hong-mei GUANG, Qing-li WANG, authorCompany=null, correspAuthors=Hong-mei GUANG, 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=1322245735580554170, articleId=1322245735077237688, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=美国近20年批准上市的放射性诊断药物的非临床研究评价概述, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

近年,随着放射性化学、核医学、分子生物学技术的发展和学科交叉融合,放射性诊断药物已成为国内外药品研发的热门领域。美国FDA近20年批准了多个新型放射性诊断药物上市,适应证涉及肿瘤、心血管疾病、帕金森综合征等诊断领域。药物的非临床研究是药物研发的关键部分,本文将梳理FDA批准上市的放射性诊断药物的非临床研究信息,总结非临床研究评价关注点,为国内该类药物的研发提供参考。

, authors=李艾芳, 光红梅, 王庆利, authorsList=李艾芳, 光红梅, 王庆利, authorCompany=null, correspAuthors=光红梅, authorNote=

李艾芳,女,助理研究员,研究方向:药物非临床研究评价。E-mail:。

, correspAuthorsNote=
光红梅,女,主任药师,研究方向:药物非临床研究评价。联系电话:(010)85243107,E-mail:。
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李艾芳,女,助理研究员,研究方向:药物非临床研究评价。E-mail:。

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李艾芳,女,助理研究员,研究方向:药物非临床研究评价。E-mail:。

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Tauvid US label[S]. 2020., articleTitle=null, refAbstract=null), Reference(id=1322245740861182932, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245735077237688, 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=FDA. Tauvid Intergrated Review (NDA 212123)[R]. 2020., articleTitle=null, refAbstract=null), Reference(id=1322245742538904533, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245735077237688, 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=FDA. 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Axumin US label[S]. 2016., articleTitle=null, refAbstract=null), Reference(id=1322245743411319774, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245735077237688, 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=FDA. Axumin Pharmacology Review (NDA 208054)[R]. 2016., articleTitle=null, refAbstract=null), Reference(id=1322245743486817247, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245735077237688, 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=FDA. Neuraceq US label[S]. 2020., articleTitle=null, refAbstract=null), Reference(id=1322245743604257760, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245735077237688, 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=FDA. Neuraceq Pharmacology Review (NDA 204677)[R]. 2014., articleTitle=null, refAbstract=null), Reference(id=1322245743709115361, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245735077237688, 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=FDA. Vizamyl US label[S]. 2019., articleTitle=null, refAbstract=null), Reference(id=1322245743784612834, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245735077237688, 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=FDA. Vizamyl Pharmacology Review (NDA 203137)[R]. 2013., articleTitle=null, refAbstract=null), Reference(id=1322245743860110307, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245735077237688, 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=FDA. Choline C11 Injection US label[S]. 2012., articleTitle=null, refAbstract=null), Reference(id=1322245743935607780, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245735077237688, 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=FDA. Choline C11 Injection Pharmacology Review (NDA 203155)[R]. 2012., articleTitle=null, refAbstract=null), Reference(id=1322245744023688165, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245735077237688, 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=FDA. Amyvid US label[S]. 2019., articleTitle=null, refAbstract=null), Reference(id=1322245744099185638, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245735077237688, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[20], rfOrder=19, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Amyvid Pharmacology Review (NDA 202008)[R]. 2012., articleTitle=null, refAbstract=null), Reference(id=1322245744191460327, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245735077237688, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[21], rfOrder=20, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. 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美国近20年批准上市的放射性诊断药物的非临床研究评价概述
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李艾芳 , 光红梅 , 王庆利
中国新药杂志 | 新药注册与审评技术 2021,30(10): 865-870
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中国新药杂志 |新药注册与审评技术 2021 , 30 (10) : 865 -870
美国近20年批准上市的放射性诊断药物的非临床研究评价概述
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李艾芳 , 光红梅 , 王庆利
作者信息
  • 国家药品监督管理局药品审评中心,北京 100022
通讯作者:
光红梅,女,主任药师,研究方向:药物非临床研究评价。联系电话:(010)85243107,E-mail:。
作者简介:

李艾芳,女,助理研究员,研究方向:药物非临床研究评价。E-mail:。

An overview of nonclinical study and evaluation of diagnostic radiopharmaceuticals approved for marketing in the United States in the last two decades
Ai-fang LI , Hong-mei GUANG , Qing-li WANG
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
出版时间: 2021-05-30
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近年,随着放射性化学、核医学、分子生物学技术的发展和学科交叉融合,放射性诊断药物已成为国内外药品研发的热门领域。美国FDA近20年批准了多个新型放射性诊断药物上市,适应证涉及肿瘤、心血管疾病、帕金森综合征等诊断领域。药物的非临床研究是药物研发的关键部分,本文将梳理FDA批准上市的放射性诊断药物的非临床研究信息,总结非临床研究评价关注点,为国内该类药物的研发提供参考。

放射性诊断药物  /  美国FDA  /  非临床研究评价

In recent years, with the development of radiochemistry, nuclear medicine and molecular biology technology and the interdisciplinary integration, diagnostic radiopharmaceuticals have become a hot field of drug research and development at home and abroad. In the past two decades, the US FDA has approved a number of new diagnostic radiopharmaceuticals for the diagnosis of tumor, cardiovascular disease, Parkinson's syndrome and other diseases. The nonclinical study of drugs is a key part of drug development. This paper sorted out the nonclinical study information of FDA-approved diagnostic radiopharmaceuticals and summarized the focus of nonclinical study and evaluation, aiming to provide information for such drugs' development in China.

diagnostic radiopharmaceuticals  /  FDA  /  nonclinical study and evaluation
李艾芳, 光红梅, 王庆利. 美国近20年批准上市的放射性诊断药物的非临床研究评价概述. 中国新药杂志, 2021 , 30 (10) : 865 -870 .
Ai-fang LI, Hong-mei GUANG, Qing-li WANG. An overview of nonclinical study and evaluation of diagnostic radiopharmaceuticals approved for marketing in the United States in the last two decades[J]. Chinese Journal of New Drugs, 2021 , 30 (10) : 865 -870 .

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2021年第30卷第10期
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  • 首发时间:2026-10-28
  • 出版时间:2021-05-30
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  • 录用日期:2020-12-29
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    国家药品监督管理局药品审评中心,北京 100022

通讯作者:

光红梅,女,主任药师,研究方向:药物非临床研究评价。联系电话:(010)85243107,E-mail:。
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2种不同金属材料的力学参数
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属
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种数
Number of
species
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Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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