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. 2010 May;20(3):615-31.
doi: 10.1080/10543400903582026.

Exposure-response modeling approach for assessing QT effect in "thorough" QT/QTc studies

Balakrishna Hosmane  1 , Charles Locke, Yi-Lin Chiu
Affiliations

Exposure-response modeling approach for assessing QT effect in "thorough" QT/QTc studies

Balakrishna Hosmane et al. J Biopharm Stat. 2010 May.

Abstract

We assess the QT effect using an exposure-response model in a "thorough QT/QTc study" 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.

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