Statistcal design and analysis for dose-response relationship in clinical trial
ZHANG Chun-mao
XIA Jie-lai
WANG Su-zhen
JIANG Zhi-wei
WANG Ling
Abstract：Dose-response relationship study is an important factor for the new drug development program and it is the foundation to determine drug efficacy and safety. Through clinical trials,the study provide the basis for dosage regimen. However, the domestic studies pay little attention to dose-response relationship. Usually, only one fixed-dose or 2 ～3 dose groups are designed in clinical trial, dose-response study is ignored. This article focuses on the importance of the research, and reviews the experimental design and analysis methods in Phase II clinical trial.
Keywords：dose-response relationshipclinical trialadaptive designmultiple comparisonsmodeling
Publication Date：2009-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 1930-1934 )