Article(id=1322246406081991160, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246381633389353, 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=1601222400000, acceptedDateStr=2020-09-28, onlineDate=1793177709360, onlineDateStr=2026-10-28, pubDate=1623686400000, pubDateStr=2021-06-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177709360, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177709360, creator=13701087609, updateTime=1793177709360, updator=13701087609, issue=Issue{id=1322246381633389353, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='11', pageStart='961', pageEnd='1056', issueExtLink='null', onlineDate='null', pubDate='1623686400000', pubDateStr='2021-06-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793177703531, creator='13701087609', updateTime=1793178125547, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322248152208486593, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246381633389353, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322248152212680898, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246381633389353, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1014, endPage=1016, ext={EN=ArticleExt(id=1322246406283317753, articleId=1322246406081991160, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=The measures of oral administration successfully in phase Ⅰ clinical trial, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Phase Ⅰ clinical trial is a preliminary clinical pharmacology and safety evaluation trial in human body to observe human tolerance to new drugs and its pharmacokinetics, providing basis for the drug administration strategy. The subjects are mainly healthy volunteers. Phase Ⅰ clinical trials are usually non-therapeutic, thus whether the drug can be successfully administered is the key of the trial. Oral administration is the most commonly used and the easiest way for administration in phase Ⅰ clinical trials; however, it is usually overlooked due to the most facility when application. To prevent errors in administration and ensure effective, smooth and correct administration, this article discusses how to deal with the risk of oral medicine, take measures, formulate the response system, and then to strengthen the management of oral administration, in order to effectively control the risk of oral medicine and guarantee the success through subject, researcher, drug administrator, quality control personnel before, during and after the drug administration.

, authors=Xiao-na LIU, Ze-juan WANG, Li-na ZHANG, Dan ZHANG, Ya-nan ZHANG, Ai-hua DU, Min LI, Ying ZHANG, Si-qi ZANG, Jin WANG, authorsList=Xiao-na LIU, Ze-juan WANG, Li-na ZHANG, Dan ZHANG, Ya-nan ZHANG, Ai-hua DU, Min LI, Ying ZHANG, Si-qi ZANG, Jin WANG, authorCompany=null, correspAuthors=Jin WANG, 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=1322246406782439930, articleId=1322246406081991160, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=Ⅰ期临床试验口服给药成功性措施的探讨, 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=

药物Ⅰ期临床试验，是初步的临床药理学及人体安全性评价试验，观察人体对于新药的耐受程度和药动学特征，为制定给药方案提供依据。试验对象以健康志愿者为主。Ⅰ期临床试验通常是非治疗性的，因此能否成功给药是试验的关键环节。口服给药在Ⅰ期临床试验中是最常见也是最容易的给药方式，但是通常最容易的也是最会被忽略的。防止临床试验过程中发生给药错误，保证能有效、顺利、正确地给药。本文通过给药前、给药中、给药后从受试者、研究者、药品管理员、质控员等多方面的角度探讨如何应对口服给药的风险，采取一定的应对措施，制定相应的制度，从而加强口服给药的管理，有效控制口服给药的风险，更好地保障给药的成功性。

, authors=刘晓娜, 王泽娟, 张丽娜, 张丹, 张娅喃, 杜爱华, 李敏, 张颖, 臧思琦, 王进, authorsList=刘晓娜, 王泽娟, 张丽娜, 张丹, 张娅喃, 杜爱华, 李敏, 张颖, 臧思琦, 王进, authorCompany=null, correspAuthors=王进, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=DY0XNFYBZVbyoZL+sQna3g==, magXml=jV7h0GSO/nYKI74WX5LYNA==, pdfUrl=null, pdf=WaEZhKibtyYyknWIfayI3g==, pdfFileSize=775941, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=fS4ACbNDKtlesaNWOJXDcw==, mapNumber=null, fund=null)}, authors=[Author(id=1322246409055752703, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322246406081991160, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=liuxiaona2449@163.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322246409143833089, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322246406081991160, authorId=1322246409055752703, language=EN, stringName=Xiao-na LIU, firstName=Xiao-na, middleName=null, lastName=LIU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Phase Ⅰ Clinical Trial Center, Aerospace Center Hospital, Beijing 100049, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322246409403879938, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322246406081991160, authorId=1322246409055752703, language=CN, stringName=刘晓娜, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=航天中心医院药物Ⅰ期临床试验研究室，北京　100049, bio={"content":"

刘晓娜，女，主管护师，主要从事临床试验质量管理研究。联系电话：（010）59972324，E-mail：liuxiaona2449@163.com。

"}, bioImg=null, bioContent=

刘晓娜，女，主管护师，主要从事临床试验质量管理研究。联系电话：（010）59972324，E-mail：liuxiaona2449@163.com。

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