豆花瓣对《Design and Analysis of Clinical Trials》的笔记(6)

Design and Analysis of Clinical Trials
  • 书名: Design and Analysis of Clinical Trials
  • 作者: Shein-Chung Chow/Jen-Pei Liu
  • 副标题: Concepts and Methodologies
  • 页数: 892
  • 出版社: Wiley
  • 出版年: 2013-11-18
  • 第9页
    ICH(INTERNATIONAL CONFERENCE ON HARMONIZATION)
    2016-11-01 22:19:50 回应
  • 第11页
    Clinical trials are scientific investigations that examine and evaluate safty and efficacy of drug therapies in human subjects.
    2016-11-01 22:50:29 回应
  • 第15页
    Experimental Unit: usually refered to as a subject from a targeted population under study.
    Treatment: any intervention to be evaluated in human subjects regardless that it is a new intervention to be tested or serves as a referenced control group for comparision.
    2016-11-19 20:52:42 回应
  • 第16页
    remedy ailments
    median overall approval time平均
    2016-11-19 21:28:44 回应
  • 第21页
    the FDA is headed by a commissioner with several deputy or associate commissioners to assist him or her in various issues such as regulatory affairs, management and operations, health affairs, science, legislative affairs, public affairs, planning and evaluation, and consumer affairs.
    2016-11-19 21:34:48 回应
  • 第27页



    2016-11-19 21:53:39 回应