昆虫迷

 找回密码
 立即注册

QQ登录

只需一步,快速开始

查看: 330|回复: 0

Statistical Thinking for Non-Statisticians in Drug Regulation[PDF]

[复制链接]

59

主题

81

帖子

454

积分

木虫

Rank: 2

积分
454
发表于 2015-7-22 07:55:52 | 显示全部楼层
Statistical Thinking for Non-Statisticians in Drug Regulation

Statistical Thinking for Non-Statisticians in Drug Regulation

Statistical Thinking for Non-Statisticians in Drug Regulation


内容简介

Written by a well-known lecturer and consultant to the pharmaceutical industry, this book focuses on the pharmaceutical non-statisticianworking within a very strict regulatory environment. Statistical Thinking for Clinical Trials in Drug Regulation presents the concepts and statistical thinking behind medical studies with a direct connection to the regulatory environment so that readers can be clear where the statistical methodology fits in with industry requirements. Pharmaceutical-related examples are used throughout to set the information in context.As a result, this book provides a detailed overview of the statistical aspects of the design, conduct, analysis and presentation of data from clinical trials within drug regulation. Statistical Thinking for Clinical Trials in Drug Regulation: Assists pharmaceutical personnel in communicating effectively with statisticians using statistical language Improves the ability to read and understand statistical methodology in papers and reports and tocritically appraise that methodology Helps to understand the statistical aspects of the regulatory framework better quoting extensively from regulatory guidelines issued by the EMEA (European Medicines Evaluation Agency), ICH (International Committee on Harmonization and the FDA (Food and Drug Administration)


Statistical_Thinking_for_Non-Statisticians_in_Drug_Regulation.pdf (2.65 MB, 下载次数: 21)
回复

使用道具 举报

您需要登录后才可以回帖 登录 | 立即注册

本版积分规则

QQ|小黑屋|手机版|昆虫迷  

滇ICP备13003927号-1 滇公网安备 53010302000180号

Powered by Discuz X3.2

快速回复 返回顶部 返回列表