期刊
DRUG INFORMATION JOURNAL
卷 40, 期 4, 页码 451-461出版社
SAGE PUBLICATIONS INC
DOI: 10.1177/216847900604000411
关键词
dose-response; adaptive; Bayesian; frequentist
Insufficient exploration of the dose-response is a shortcoming of clinical drug development, and failure to characterize dosing early is often cited as a key contributor to the high late-stage attrition rate currently faced by the industry. Adaptive methods, for example, make it feasible to design a proof-of-concept study as an adaptive dose-response trial. Efficient learning about the dose response earlier in development will ultimately reduce overall costs and provide better information on dose in the filing package. This article presents the Pharmaceutical Research and Manufacturers of America working group's main recommendations regarding adaptive dose-response studies. As background, traditional fixed and adaptive dose-response design's are briefly reviewed. Information on developing a Bayesian adaptive dose design and some monitoring and processing issues are also discussed.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据