Article(id=1322245744183067120, 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=1603900800000, acceptedDateStr=2020-10-29, onlineDate=1793177551551, onlineDateStr=2026-10-28, pubDate=1622304000000, pubDateStr=2021-05-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177551551, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177551551, creator=13701087609, updateTime=1793177551551, 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=893, endPage=897, ext={EN=ArticleExt(id=1322245744363422193, articleId=1322245744183067120, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Overview of the nonclinical study and evaluation of therapeutic drugs for transthyretin amyloidosis disease, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Transthyretin amyloidosis (ATTR) disease is caused by abnormal folding of transthyretin (TTR) in tissues, which mainly involves the peripheral nervous system and heart, progressively aggravates to even be life-threatening. Currently, 3 TTR-targeted therapeutic drugs have been marketed in the United States and Europe. The information from these drugs' nonclinical pharmacology and toxicology studies has important implications for 3 clinical effectiveness and safety. This article summarized the key points of the nonclinical studies of these three TTR-targeted therapeutic drugs and elaborated the focus of nonclinical study and evaluation of TTR-targeted therapeutic drugs for ATTR disease from the aspects of nonclinical effectiveness and nonclinical safety to provide information for new drug 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=1322245744657023474, articleId=1322245744183067120, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=转甲状腺素蛋白淀粉样变性疾病治疗药物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=

转甲状腺素蛋白淀粉样变性（transthyretin amyloidosis，ATTR）疾病是由转甲状腺素蛋白（transthyretin，TTR）错误折叠导致其在组织中异常沉积引起的疾病，主要累及外周神经系统和心脏，表现为进行性加重至危及生命。目前，国外已有3个靶向TTR的治疗药物在美国和欧洲上市，其非临床药效学及毒理学研究信息对临床有效性及安全性具有重要的提示意义。本文将梳理靶向TTR治疗药物的非临床研究要点，从非临床有效性评价、非临床安全性评价两方面阐述ATTR疾病靶向TTR治疗药物的非临床研究评价关注点，为国内药物研发提供参考。

, 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=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=EgiiJGAt93j+ShUx6Y5j/A==, magXml=sgtqjQDoMsOjE3AVwjKBNw==, pdfUrl=null, pdf=DGvM3svK27xKuGqhxXCUCA==, pdfFileSize=968919, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=KBhmeic5Gw+VohZvnuMFcw==, mapNumber=null, fund=null)}, authors=[Author(id=1322245745021927927, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245744183067120, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=behealthy@163.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322245745105814009, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245744183067120, authorId=1322245745021927927, language=EN, stringName=Ai-fang LI, firstName=Ai-fang, middleName=null, lastName=LI, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322245745172922874, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322245744183067120, authorId=1322245745021927927, language=CN, stringName=李艾芳, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评中心，北京　100022, bio={"content":"

李艾芳，女，助理研究员，研究方向：药物非临床研究评价。E-mail：behealthy@163.com。

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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：behealthy@163.com。

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