Concentration-Response Modeling of ECG Data From Early-Phase Clinical Studies as an Alternative Clinical and Regulatory Approach to Assessing QT Risk - Experience From the Development Program of Lemborexant

Operational Characteristics of Linear Concentration-QT Models for Assessing QTc Interval in the Thorough QT and Phase I Clinical Studies

(2016) C Garnett et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Results From the IQ-CSRC Prospective Study Support Replacement of the Thorough QT Study by QT Assessment in the Early Clinical Phase

(2015) B Darpo et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14

(2015) Borje Darpo et al.   DRUG SAFETY

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

(2014) Philip T. Sager et al.   ANNALS OF NONINVASIVE ELECTROCARDIOLOGY

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

(2014) Georg Ferber et al.   ANNALS OF NONINVASIVE ELECTROCARDIOLOGY

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

(2014) Robert C. Shumaker et al.   CANCER CHEMOTHERAPY AND PHARMACOLOGY

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

(2014) Borje Darpo et al.   Diabetes Therapy

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

(2013) Borje Darpo et al.   ANNALS OF NONINVASIVE ELECTROCARDIOLOGY

Early Investigation of QTc Liability

(2013) Rashmi R. Shah et al.   DRUG SAFETY

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

(2012) Borje Darpo et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Creation of a Knowledge Management System for QT Analyses

(2010) Christoffer W. Tornøe et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Statistical Issues Including Design and Sample Size Calculation in Thorough QT/QTc Studies∗

(2008) Joanne Zhang et al.   Journal of Biopharmaceutical Statistics

Performance Characteristics for Some Typical QT Study Designs Under the ICH E-14 Guidance

(2008) Matthew M. Hutmacher et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Near-Thorough QT Study as Part of a First-In-Man Study

(2008) Marek Malik et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Design of the “Thorough QT Study”

(2007) B Darpo et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Concentration-QT Relationships Play a Key Role in the Evaluation of Proarrhythmic Risk During Regulatory Review

(2007) Christin E. Garnett et al.   JOURNAL OF CLINICAL PHARMACOLOGY