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December 24, 2012British Journal of Clinical PharmacologyOpen Access

Early QT assessment – how can our confidence in the data be improved?

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BDBörje DarpöElectrophysiology CGChristine GarnettUnited States Food and Drug Administration

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Implication

May support QTc exclusion via phase 1 exposure-response analysis; leaves open replacement of thorough QT studies.

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Key points are not available for this paper at this time.

Cite This Study

Darpö et al. (2012) studied this question.

synapsesocial.com/papers/6a70b0ff31a3df824328f2a6 https://doi.org/10.1111/bcp.12068

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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

1The IQ‐CSRC Prospective Clinical Phase 1 Study: “Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?”2013 · 100 citations
2Evaluating cardiac risk: exposure response analysis in early clinical drug development2018 · 17 citations
3Enabling robust assessment of QTc prolongation in early phase clinical trials2017 · 14 citations
4The Power of Phase I Studies to Detect Clinical Relevant QTc Prolongation: A Resampling Simulation Study2015 · 23 citations
5Time for a Fully Integrated Nonclinical–Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective2020 · 97 citations