Scientific Publications

Comparing QT interval variability of semiautomated and high-precision ECG methodologies in seven thorough QT studies—implications for the power of studies intended for definitive evaluation of a drug’s QT effect

Karin Meiser PhD, Pierre Jordaan MD, Sasha Latypova MBA, Borje Darpo MD, PhD

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Can Bias Evaluation Provide Protection Against False-Negative Results in QT Studies Without a Positive Control Using Exposure-Response Analysis?

Ferber G, Zhou M, Dota C, Garnett C, Keirns J, Malik M, Stockbridge N, Darpo B

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The Thorough QT Study: Is Its Demise on the Horizon?

Sager P, Kowey P

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The IQ-CSRC Prospective Clinical Phase 1 Study: Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?

Darpo B, Sarapa N, Garnett C, Benson C,  Dota C, Ferber G,  Jarugula V,  Johannesen L,  Keirns J, Krudys K, Ortemann-Renon C, Riley S, Rogers-Subramaniam D, Stockbridge N

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Differentiating the Effect of an Opioid Agonist on Cardiac Repolarization From µ-Receptor-mediated, Indirect Effects on the QT Interval: A Randomized, 3-way Crossover Study in Healthy Subjects

Darpo B, Zhou M, Bai SA, Ferber G, Xiang Q, Finn A.

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Albiglutide Does Not Prolong QTc Interval in Healthy Subjects: A Thorough ECG Study

Darpo B, Zhou M, Matthews J, Zhi H, Young MA, Perry C, Reinhardt RR

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Detection of QTc Effects in Small Studies – Implications for Replacing the Thorough QT Study

Ferber G., Zhou M., Darpo, B.

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Improving the Precision of QT measurements (Early Precision QT Method Validation)

Darpo B, Fossa A,  Couderc JP, Zhou M, Schreyer A, Ticktin M, Zapesochny, A

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Effect of lenvatinib (E7080) on the QTc interval: results from a thorough QT study in healthy volunteers

Shumaker RC, Zhou M, Ren M, Fan J, Martinez G, Aluri J, Darpo B.

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

Darpo B1, Garnett C.

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Highly automated QT measurement techniques in 7 thorough QT studies implemented under ICH E14 guidelines.

Couderc JP, Garnett C, Li M, Handzel R, McNitt S, Xia X, Polonsky S, Zareba W.

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