Article(id=1322180239166386308, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180233244038010, 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=1620144000000, acceptedDateStr=2021-05-05, onlineDate=1793161933937, onlineDateStr=2026-10-28, pubDate=1631635200000, pubDateStr=2021-09-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793161933937, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793161933937, creator=13701087609, updateTime=1793161933937, updator=13701087609, issue=Issue{id=1322180233244038010, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='17', pageStart='1537', pageEnd='1632', issueExtLink='null', onlineDate='null', pubDate='1631635200000', pubDateStr='2021-09-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793161932525, creator='13701087609', updateTime=1793162118166, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322181011941732619, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180233244038010, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322181011945926924, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180233244038010, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1546, endPage=1553, ext={EN=ArticleExt(id=1322180239359324293, articleId=1322180239166386308, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Research on adaptive licensing pathway for new drug registration, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Adaptive licensing (AL) is a prospectively planned, flexible approach for the regulation of drugs and biologics. AL is based on the stakeholder model of patients, health-care providers, payers, and regulators, seeking maximizing the positive impact of new drugs on public health by balancing timely access for patients with the need to assess and provide adequate evolving information on benefits and harms, so that better-informed patient-care decisions can be made. This paper reviews the emergence and development of AL, deeply analyzed the principles and design ideas of AL, and discussed the risk management and safeguard measures in AL. This paper will provide theoretical and practical reference for the construction of AL pathway in China.

, authors=Li YANG, Yu-wen CHEN, Di WU, Yan-yi WEI, Zu-guang WANG, authorsList=Li YANG, Yu-wen CHEN, Di WU, Yan-yi WEI, Zu-guang WANG, authorCompany=null, correspAuthors=Yu-wen CHEN, 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=1322180239669702790, articleId=1322180239166386308, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=新药注册适应性批准路径研究, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

适应性批准是基于监管科学理念下前瞻性、灵活地对药品和生物制品进行审评审批的路径。该路径建立在监管机构、患者、医药企业和医疗付费者的新药研发合作伙伴模式之上，兼顾各方利益，尽可能地减少风险，提高效率和效益，加快新药研发和上市批准进程。本文梳理了适应性批准的产生与发展，对适应性批准的原理和设计思想进行了深入分析，并对适应性批准中的风险管理和保障措施进行了探讨，为我国适应性批准路径的构建提供理论和实践参考。

, authors=杨莉, 陈玉文, 吴迪, 韦彦伊, 王祖光, authorsList=杨莉, 陈玉文, 吴迪, 韦彦伊, 王祖光, authorCompany=null, correspAuthors=陈玉文, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=GbbgzFPQsBk5WeAlVEClnQ==, magXml=xGFdWGp2YDX7FlU0sPXwBg==, pdfUrl=null, pdf=6FIS3ryLHVVc0RSq0tdjQg==, pdfFileSize=1931730, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=K7L6wsbweXP//jWs2i9u9Q==, mapNumber=null, fund=null)}, authors=[Author(id=1322180240114299019, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=yanglishanxi@126.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322180240198185101, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, authorId=1322180240114299019, language=EN, stringName=Li YANG, firstName=Li, middleName=null, lastName=YANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322180240269488270, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, authorId=1322180240114299019, language=CN, stringName=杨莉, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=沈阳药科大学工商管理学院，沈阳　110016, bio={"content":"

杨莉，女，副教授，研究方向：药品法规与政策、监管科学。E-mail：yanglishanxi@126.com。

"}, bioImg=null, bioContent=

杨莉，女，副教授，研究方向：药品法规与政策、监管科学。E-mail：yanglishanxi@126.com。

, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322180239875223687, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, xref=null, ext=[AuthorCompanyExt(id=1322180240009441416, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, companyId=1322180239875223687, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China), AuthorCompanyExt(id=1322180240022024329, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, companyId=1322180239875223687, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=沈阳药科大学工商管理学院，沈阳　110016)])]), Author(id=1322180240365957264, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, orderNo=1, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=cywwyc@163.com, emailSecond=null, emailThird=null, correspondingAuthor=1, authorType=1, ext={EN=AuthorExt(id=1322180240458231954, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, authorId=1322180240365957264, language=EN, stringName=Yu-wen CHEN, firstName=Yu-wen, middleName=null, lastName=CHEN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322180240533729427, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, authorId=1322180240365957264, language=CN, stringName=陈玉文, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=沈阳药科大学工商管理学院，沈阳　110016, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322180239875223687, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, xref=null, ext=[AuthorCompanyExt(id=1322180240009441416, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, companyId=1322180239875223687, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China), AuthorCompanyExt(id=1322180240022024329, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, companyId=1322180239875223687, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=沈阳药科大学工商管理学院，沈阳　110016)])]), Author(id=1322180240621809813, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, 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=1322180240701501591, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, authorId=1322180240621809813, language=EN, stringName=Di WU, firstName=Di, middleName=null, lastName=WU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322180240768610456, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, authorId=1322180240621809813, language=CN, stringName=吴迪, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=沈阳药科大学工商管理学院，沈阳　110016, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322180239875223687, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, xref=null, ext=[AuthorCompanyExt(id=1322180240009441416, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, companyId=1322180239875223687, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China), AuthorCompanyExt(id=1322180240022024329, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, companyId=1322180239875223687, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=沈阳药科大学工商管理学院，沈阳　110016)])]), Author(id=1322180240831525018, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, 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=1322180240902828188, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, authorId=1322180240831525018, language=EN, stringName=Yan-yi WEI, firstName=Yan-yi, middleName=null, lastName=WEI, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322180240982519965, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, authorId=1322180240831525018, language=CN, stringName=韦彦伊, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=沈阳药科大学工商管理学院，沈阳　110016, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322180239875223687, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, xref=null, ext=[AuthorCompanyExt(id=1322180240009441416, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, companyId=1322180239875223687, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China), AuthorCompanyExt(id=1322180240022024329, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, companyId=1322180239875223687, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=沈阳药科大学工商管理学院，沈阳　110016)])]), Author(id=1322180241070600351, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, orderNo=4, 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=1322180241213206689, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, authorId=1322180241070600351, language=EN, stringName=Zu-guang WANG, firstName=Zu-guang, middleName=null, lastName=WANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322180241322258594, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, authorId=1322180241070600351, language=CN, stringName=王祖光, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=沈阳药科大学工商管理学院，沈阳　110016, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322180239875223687, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, xref=null, ext=[AuthorCompanyExt(id=1322180240009441416, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, companyId=1322180239875223687, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China), AuthorCompanyExt(id=1322180240022024329, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, companyId=1322180239875223687, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=沈阳药科大学工商管理学院，沈阳　110016)])])], keywords=[Keyword(id=1322180241502613667, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, language=EN, orderNo=1, keyword=new drug), Keyword(id=1322180241628442788, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, language=EN, orderNo=2, keyword=registration), Keyword(id=1322180241741688997, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, language=EN, orderNo=3, keyword=adaptive licensing), Keyword(id=1322180241854935206, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, language=EN, orderNo=4, keyword=pathway), Keyword(id=1322180243524268201, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, language=CN, orderNo=1, keyword=新药), Keyword(id=1322180243587182762, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, language=CN, orderNo=2, keyword=注册), Keyword(id=1322180243650097323, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, language=CN, orderNo=3, keyword=适应性批准), Keyword(id=1322180243729789101, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, language=CN, orderNo=4, keyword=路径)], refs=[Reference(id=1322180244266660018, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, 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=European Medicines Agency. Press release: European Medicines Agency launches adaptive licensing pilot project[EB/OL]. (2014-03-19) [2020-12-25]. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/03/news_detail_002046.jsp&mid=WC0b01ac058004d5c1>(2014)., articleTitle=null, refAbstract=null), Reference(id=1322180244384100532, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, 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=衡明莉, 王北琪, 王骏. 对美国FDA适应性设计指导原则的介绍[J]. 中国临床药理学杂志, 2019, 35(12): 1316-1320., articleTitle=null, refAbstract=null), Reference(id=1322180244451209397, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, 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=白桦, 张抒扬. 有关促进国内罕见病药物临床试验的几点建议[J]. 国际药学研究杂志, 2019, 46(9): 679-684., articleTitle=null, refAbstract=null), Reference(id=1322180244530901174, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, 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=刘炳林. 药物临床试验中有效性指标的分类[J]. 中国新药杂志, 2016, 25(10): 1103-1107., articleTitle=null, refAbstract=null), Reference(id=1322180244618981559, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, 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=孙宇昕, 魏芬芳, 杨悦. 美国FDA药品审评中替代终点开发与应用[J]. 中国药学杂志, 2017, 52(5): 414-419., articleTitle=null, refAbstract=null), Reference(id=1322180244694479032, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, 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=国家药品监督管理局药品审评中心. 药物临床试验富集策略与设计指导原则(征求意见稿)[S]. 2020., articleTitle=null, refAbstract=null), Reference(id=1322180244761587897, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, 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=杨志敏, 李宁, 高晨燕, 等. 富集设计的理论与方法及其在新药临床开发中的应用[J]. 中国新药杂志, 2014, 23(8): 915-920, 947., articleTitle=null, refAbstract=null), Reference(id=1322180244832891066, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, 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=ROLAND M, TORGERSON DJ. What are pragmatic trials[J]? BMJ, 1998, 316(7127): 285., articleTitle=null, refAbstract=null), Reference(id=1322180244908388539, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, 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=SINGH J. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use[J]. J Pharmacol Pharmacother, 2015, 6(3): 185-187., articleTitle=null, refAbstract=null), Reference(id=1322180244996468924, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[11], rfOrder=9, authorNames=null, journalName=null, refType=null, unstructuredReference=KESHAV BS. Non-inferiority and equivalence trials: Need for a standardized process[J]. Perspect Clin Res, 2011, 2(4): 115-118., articleTitle=null, refAbstract=null), Reference(id=1322180245071966397, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[12], rfOrder=10, authorNames=null, journalName=null, refType=null, unstructuredReference=毛静怡, 柳丽丽, 潘永卉. 美国药物治疗管理对我国药学服务的启示[J]. 现代药物与临床, 2017, 32(10): 2031-2035., articleTitle=null, refAbstract=null), Reference(id=1322180245155852478, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[13], rfOrder=11, authorNames=null, journalName=null, refType=null, unstructuredReference=Medication therapy management in pharmacy practice: core elements of an MTM service model (version 2.0)[J]. J Am Pharm Assoc, 2008, 48(3): 341-353., articleTitle=null, refAbstract=null), Reference(id=1322180245239738559, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[14], rfOrder=12, authorNames=null, journalName=null, refType=null, unstructuredReference=杨悦.《21世纪治愈法案》[M]. 北京: 中国医药科技出版社, 2018: 5-7., articleTitle=null, refAbstract=null), Reference(id=1322180245348790465, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[15], rfOrder=13, authorNames=null, journalName=null, refType=null, unstructuredReference=董铎, 吴桂枝, 程刚. 欧盟新法规下的药物警戒制度简介[J]. 中国药物警戒, 2012, 9(11): 662-665., articleTitle=null, refAbstract=null), Reference(id=1322180245449453762, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[16], rfOrder=14, authorNames=null, journalName=null, refType=null, unstructuredReference=MIT. About MIT NEWDIGS[EB/OL]. (2020-10-23) [2020-12-23]. http://newdigs.mit.edu/about., articleTitle=null, refAbstract=null), Reference(id=1322180245520756931, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[17], rfOrder=15, authorNames=null, journalName=null, refType=null, unstructuredReference=EICHLER HG, BAIRD LG, BARKER R, et al. From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients[J]. Clin Pharmacol Ther, 2015, 97(3): 234-246., articleTitle=null, refAbstract=null)], funds=[Fund(id=1322180244023390383, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, awardId=null, language=CN, fundingSource=中国药品监督管理研究会2021年研究课题, fundOrder=null, country=null), Fund(id=1322180244098887856, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, awardId=GGJJ20181015, language=CN, fundingSource=沈阳药科大学归国人员启动基金(GGJJ20181015), fundOrder=null, country=null), Fund(id=1322180244178579633, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, awardId=2019WFW02, language=CN, fundingSource=辽宁省教育厅科学研究经费项目(2019WFW02), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1322180239875223687, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, xref=null, ext=[AuthorCompanyExt(id=1322180240009441416, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, companyId=1322180239875223687, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China), AuthorCompanyExt(id=1322180240022024329, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180239166386308, companyId=1322180239875223687, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=沈阳药科大学工商管理学院，沈阳　110016)])], 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/Y2021/V30/I17/1546, detailUrlEn=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/Y2021/V30/I17/1546, pdfUrlCn=https://castjournals.cast.org.cn/joweb/zgxyzz/CN/PDF/Y2021/V30/I17/1546, pdfUrlEn=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/PDF/Y2021/V30/I17/1546, aliStartDate=0, aliEndDate=0, collectionFlag=false, citedCount=null, citedUrl=null, previewStatus=0, delFlag=0, hasFullText=0, orderTime=1631635200000, fullTextJson=null, articleText=null, reference=null)