H-化学药物和生物制品临床试验的生物统计学技术指导原则 20080904.docVIP

下载本文档

0
0
约1.78万字
约 26页
2021-11-08 发布于上海
举报
版权申诉

H-化学药物和生物制品临床试验的生物统计学技术指导原则 20080904.doc

此“医疗卫生”领域文档为创作者个人分享资料，不作为权威性指导和指引，仅供参考

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

精品资料精品资料 PAGE / NUMPAGES 精品资料指导原则编号：【 H 】G C L 4 - 1 化学药物和生物制品临床试验的生物统计学技术指导原则二○○五年三月目录一、概述··················································································································································· 1 二、整个临床试验的基本考虑··································································································1 (一)探索性试验和确证性试验·······························································································1 (二)观察指标····································································································································2 (三)偏倚的控制······························································································································4 三、试验设计中的基本考虑········································································································8 (一)试验设计的类型····················································································································8 (二)多中心试验·······························································································································10 (三)比较的类型·······························································································································10 (四)样本量········································································································································11 (五)资料的收集·····························································································································12 四、试验进行中的基本考虑······································································································12 (一)期中分析···································································································································12 (二)试