药械指南

订阅

MedSci主页 / 所有栏目 / 药械指南

新药Ⅱ期和Ⅲ期临床试验药学申报资料的内容及格式要求

2013-08-01 美国食品和药品监督管理局 FDA

申报

新药Ⅱ期和Ⅲ期临床试验药学申报资料的内容及格式要求

中文标题：

新药Ⅱ期和Ⅲ期临床试验药学申报资料的内容及格式要求

发布机构：

美国食品和药品监督管理局

发布日期：

2013-08-01

简要介绍：

新药Ⅱ期和Ⅲ期临床试验药学申报资料的内容及格式要求

相关资料下载：
[AttachmentFileName(sort=1, fileName=新药Ⅱ期和Ⅲ期临床试验药学申报资料的内容及格式要.pdf)] GetToolGuiderByIdResponse(projectId=1, id=5f16c1c0021a509d, title=新药Ⅱ期和Ⅲ期临床试验药学申报资料的内容及格式要求, enTitle=, guiderFrom=FDA, authorId=0, author=, summary=新药Ⅱ期和Ⅲ期临床试验药学申报资料的内容及格式要求, cover=, journalId=0, articlesId=null, associationId=486, associationName=美国食品和药品监督管理局, associationIntro=美国食品和药品监督管理局是美国公共卫生及服务部的一个代理商，其由委员会办公室和4个监督核心功能理事机构组成。, copyright=0, guiderPublishedTime=Thu Aug 01 00:00:00 CST 2013, originalUrl=, linkOutUrl=, content=<h3 class="doc-title" style="color: #222222;">新药Ⅱ期和Ⅲ期临床试验药学申报资料的内容及格式要求</h3>, tagList=[TagDto(tagId=17725, tagName=申报)], categoryList=[CategoryDto(categoryId=11, categoryName=药械, tenant=100), CategoryDto(categoryId=85, categoryName=指南&解读, tenant=100), CategoryDto(categoryId=21100, categoryName=达仁堂循证e学界, tenant=100)], articleKeywordId=0, articleKeyword=, articleKeywordNum=6, guiderKeywordId=0, guiderKeyword=, guiderKeywordNum=6, haveAttachments=1, attachmentList=null, guiderType=0, guiderArea=指南, guiderLanguage=0, guiderRegion=3, opened=0, paymentType=, paymentAmount=30, recommend=0, recommendEndTime=null, sticky=0, stickyEndTime=null, allHits=1564, appHits=36, showAppHits=0, pcHits=403, showPcHits=1528, likes=2, shares=5, comments=2, approvalStatus=1, publishedTime=Tue Aug 03 18:01:55 CST 2021, publishedTimeString=2013-08-01, pcVisible=1, appVisible=1, editorId=4754896, editor=fbzhang, waterMark=0, formatted=0, memberCards=[], isPrivilege=0, deleted=0, version=2, createdBy=null, createdName=fbzhang, createdTime=Tue Aug 03 18:01:50 CST 2021, updatedBy=4754896, updatedName=fbzhang, updatedTime=Sat Jan 06 17:43:55 CST 2024, courseDetails=[], otherVersionGuiders=[], isGuiderMember=false, ipAttribution=, attachmentFileNameList=[AttachmentFileName(sort=1, fileName=新药Ⅱ期和Ⅲ期临床试验药学申报资料的内容及格式要.pdf)])
新药Ⅱ期和Ⅲ期临床试验药学申报资料的内容及格式要.pdf
下载请点击：
评论区 (2)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1004944, encodeId=f6ef1004944a9, content=很有意义帮助很大, beContent=null, objectType=guider, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=42f95542972, createdName=beautifullive, createdTime=Tue Aug 03 19:41:05 CST 2021, time=2021-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1004933, encodeId=983c1004933e0, content=沙发, beContent=null, objectType=guider, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210803/6cc13e7743304d2eabaa612d31f93f43/bc9ac25186d5401c8963fab3bf477fff.jpg, createdBy=19445562994, createdName=ms8000000863622125, createdTime=Tue Aug 03 18:31:20 CST 2021, time=2021-08-03, status=1, ipAttribution=)]
    2021-08-03 beautifullive

    很有意义帮助很大

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1004944, encodeId=f6ef1004944a9, content=很有意义帮助很大, beContent=null, objectType=guider, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=42f95542972, createdName=beautifullive, createdTime=Tue Aug 03 19:41:05 CST 2021, time=2021-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1004933, encodeId=983c1004933e0, content=沙发, beContent=null, objectType=guider, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210803/6cc13e7743304d2eabaa612d31f93f43/bc9ac25186d5401c8963fab3bf477fff.jpg, createdBy=19445562994, createdName=ms8000000863622125, createdTime=Tue Aug 03 18:31:20 CST 2021, time=2021-08-03, status=1, ipAttribution=)]
    2021-08-03 ms8000000863622125

    沙发

    0