Exposure-Response Modeling Approach for Assessing QT Effect in Thorough QT/QTc Studies

被引：3
|
作者：
Hosmane, Balakrishna [1 ]
Locke, Charles [2 ]
Chiu, Yi-Lin [2 ]
机构：
[1] No Illinois Univ, Div Stat, De Kalb, IL 60115 USA
[2] Abbott Labs, Abbott Pk, IL 60064 USA
来源：
JOURNAL OF BIOPHARMACEUTICAL STATISTICS | 2010年 / 20卷 / 03期
关键词：
Alternative strategy; Exposure-response model; Intersection-union test;
D O I：
10.1080/10543400903582026
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
We assess the QT effect using an exposure-response model in a othorough QT/QTc studyo with a four-period crossover design in which the treatments are placebo, positive control, higher dose of investigational drug, and therapeutic dose of investigational drug. In the study, QTc interval values and the drug concentrations are obtained for several specified times during treatment. This approach to the assessment of non-inferiority of the higher dose to placebo is an alternative strategy suggested in ICH-E14 guideline (Section 2.2.5) to the intersection-union test.
引用
收藏
页码：624 / 640
页数：17
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