Why the study?
Does concentration-response modeling provide valid and unbiased estimates of drug-induced QT prolongation compared to standard time-matched analysis?
Population
Data sets of New Drug Applications used for assessing drug-induced QT prolongation
Comparison
Concentration-response modeling vs Standard time-matched mean effect analysis
Design
Other
Authors
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Caution against uncritical concentration-response modeling for QTc; leaves open its validity versus time-matched analysis.
Does concentration-response modeling provide valid and unbiased estimates of drug-induced QT prolongation compared to standard time-matched analysis?
The uncritical use of linear concentration-response modeling for assessing drug-induced QT prolongation can lead to severe statistical bias.
Tsong et al. (2008) studied this question.
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