Sample Size Calculation for Thorough QT/QTc Study Considering Various Factors Related to Multiple Time Points

被引：5
|
作者：
Meng, Zhaoling [1 ]
Kringle, Robert [1 ]
Chen, Xun [1 ]
Zhao, Peng-Liang [1 ]
机构：
[1] Sanofi Aventis, Biostat & Programming, Bridgewater, NJ 08807 USA
来源：
JOURNAL OF BIOPHARMACEUTICAL STATISTICS | 2010年 / 20卷 / 03期
关键词：
False positive; IUT test; Multiple test correction; Positive control; Power; QT; TRIALS; POWER;
D O I：
10.1080/10543400903581986
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
The sample size requirement in a thorough QT/QTc study is discussed under a balanced parallel or crossover study design. First, we explore the impacts of various factors on the study power, including the mean effect profile across time and correlation among time points. Then we estimate the variability parameters needed based on multiple historical studies. Different baseline usage is illustrated to have a significant impact on the analysis variability in the parallel studies. Finally, the sample size calculations and recommendations are given for demonstrating a onegativeo drug effect and the study assay sensitivity, respectively.
引用
收藏
页码：580 / 594
页数：15
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