天然药物临床研究资料综述撰写技术指导原则.DOCVIP

下载本文档

7
0
约8.47千字
约 19页
2016-01-05 发布于湖北
举报
版权申诉

天然药物临床研究资料综述撰写技术指导原则.DOC

1、有哪些信誉好的足球投注网站（book118）网站文档一经付费（服务费），不意味着购买了该文档的版权，仅供个人/单位学习、研究之用，不得用于商业用途，未经授权，严禁复制、发行、汇编、翻译或者网络传播等，侵权必究。。
2、本站所有内容均由合作方或网友上传，本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺！文档内容仅供研究参考，付费前请自行鉴别。如您付费，意味着您自己接受本站规则且自行承担风险，本站不退款、不进行额外附加服务；查看《如何避免下载的几个坑》。如果您已付费下载过本站文档，您可以点击这里二次下载。
3、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等，请点击“版权申诉”（推荐），也可以打举报电话：400-050-0827(电话支持时间：9:00-18:30)。
4、该文档为VIP文档，如果想要下载，成为VIP会员后，下载免费。
5、成为VIP后，下载本文档将扣除1次下载权益。下载后，不支持退款、换文档。如有疑问请联系我们。
6、成为VIP后，您将拥有八大权益，权益包括：VIP文档下载权益、阅读免打扰、文档格式转换、高级专利检索、专属身份标志、高级客服、多端互通、版权登记。
7、VIP文档为合作方或网友上传，每下载1次，网站将根据用户上传文档的质量评分、类型等，对文档贡献者给予高额补贴、流量扶持。如果你也想贡献VIP文档。上传文档

天然药物临床研究资料综述撰写技术指导原则.DOC

中药、天然药物临床研究资料综述撰写格式和要求技术指导原则（第二稿草稿）二OO 五年三月 1 目录一. 概述································································································································ 1 二. 撰写格式和要求· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·· · · · · · · · · · · · · · 1 (一) 申请临床研究········································································································· 1 1. 主要内容··················································································································· 1 1.1 命名依据·············································································································· 1 1.2 立题目的和依据································································································ 1 1.3 临床研究计划····································································································· 2 1.3.1 人体耐受性试验方案················································································ 2 1.3.2 Ⅱ期临床试验方案························································································· 2 2. 分析与评价···························································································· 3 (二) 申请生产·················································································································· 3 1. 主要内容··················································································································· 4 1.1 Ⅰ期临床试验概要··························································································· 4 1.1.1 人体耐受性试验概要··············································································· 4 1.1.2 临床药理学试验概要··············································································· 4 1.2 Ⅱ期临床试验概要····························································································· 5 1.3 Ⅲ期临床试验概要····························································································· 5 2. 分析与评价········································