Why the study?
Does moxifloxacin affect QT interval compared to placebo in thorough QT studies?
Does moxifloxacin affect QT interval compared to placebo in thorough QT studies?
This meta-analysis evaluates statistical models for assessing the effect of moxifloxacin on QT intervals to validate assay sensitivity in thorough QT studies.
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Strengthens assay sensitivity validation in TQT studies; extends statistical model evaluation for moxifloxacin QT effects.
The ICH guidelines indicate that a single "thorough QT study" should be conducted to evaluate the effects of new drugs on cardiac repolarization. A positive control, such as moxifloxacin, is required to be assessed as part of the thorough QT study to validate the assay sensitivity of each study. In order to better understand the effect of moxifloxacin, a meta-analysis of nine thorough QT studies has been undertaken to assess the overall moxifloxacin effect. The data was analyzed using a repeated measures mixed model to test various covariance structures to identify the most suitable model for this and future meta-analyses of thorough QT studies.
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Stylianou et al. (2008) studied this question.
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