April 1, 2018Drug Healthcare and Patient SafetyOpen Access

Evaluating cardiac risk: exposure response analysis in early clinical drug development

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Comparison

Exposure response modeling of intensive… vs Dedicated thorough QT (TQT) study

Design

Review

Authors

JGJulie GrenierPharmaxis (Canada)SPSabina PaglialungaCelerion (United States)BMBruce H. MorimotoBooz Allen Hamilton (United States)

Discussion

Member takes

Implication

Regulators now accept ER modeling of early ECG data for proarrhythmia risk; extends flexibility for drug developers beyond dedicated TQT studies.

Structured PICO

Intervention

Exposure response (ER) modeling of intensive electrocardiogram (ECG) data

Comparator

Dedicated thorough QT (TQT) study

Outcome

Assessment of proarrhythmia risk (QT liability)safety

Exposure response modeling of intensive ECG data during early clinical development provides an alternative to dedicated thorough QT studies for evaluating drug-induced proarrhythmia risk.

Cite This Study

Grenier et al. (2018) studied this question.

synapsesocial.com/papers/6a70b0ff31a3df824328f297 https://doi.org/10.2147/dhps.s133286

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Implication

Regulators now accept ER modeling of early ECG data for proarrhythmia risk; extends flexibility for drug developers beyond dedicated TQT studies.

Evaluating cardiac risk: exposure response analysis in early clinical drug development

Discussion

Member takes

Implication

Structured PICO

Cite This Study

Evaluating cardiac risk: exposure response analysis in early clinical drug development

Discussion

Member takes

Implication

Structured PICO

Cite This Study

Also Consider

Also Consider