Why the study?
Does bias evaluation provide protection against false-negative results in QT studies without a positive control using exposure-response analysis?
Does bias evaluation provide protection against false-negative results in QT studies without a positive control using exposure-response analysis?
Severe and detectable bias must be introduced into reported QTc values to cause false-negative predictions with exposure-response analysis, suggesting bias evaluation can protect against false negatives in QT studies without a positive control.
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Bias evaluation may protect QT studies without positive controls from false-negatives; leaves open real-world validation before routine adoption.
Ferber et al. (2016) studied this question.
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