Assessment of the effect of erdafitinib on cardiac safety: analysis of ECGs and exposure–QTc in patients with advanced or refractory solid tumors

Scientific white paper on concentration-QTc modeling

(2017) Christine Garnett et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Discovery and Pharmacological Characterization of JNJ-42756493 (Erdafitinib), a Functionally Selective Small-Molecule FGFR Family Inhibitor

(2017) Timothy P.S. Perera et al.   MOLECULAR CANCER 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

Phase I Dose-Escalation Study of JNJ-42756493, an Oral Pan–Fibroblast Growth Factor Receptor Inhibitor, in Patients With Advanced Solid Tumors

(2015) Josep Tabernero et al.   JOURNAL OF CLINICAL ONCOLOGY

Cardiac Safety Research Consortium: Can the thorough QT/QTc study be replaced by early QT assessment in routine clinical pharmacology studies? Scientific update and a research proposal for a path forward

(2014) Borje Darpo et al.   AMERICAN HEART JOURNAL

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

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

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

Baseline Correction in Parallel Thorough QT Studies

(2013) Joanne Zhang et al.   DRUG SAFETY

Assessing the Probability of Drug-Induced QTc-Interval Prolongation During Clinical Drug Development

(2011) A S Y Chain et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Comparison of QTc Data Analysis Methods Recommended by the ICH E14 Guidance and Exposure–Response Analysis: Case Study of a Thorough QT Study of Asenapine

(2010) S Chapel et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Challenges of characterizing proarrhythmic risk due to QTc prolongation induced by nonadjuvant anticancer agents

(2008) Nenad Sarapa et al.   Expert Opinion On Drug Safety

A Perspective on the Use of Concentration-QT Modeling in Drug Development

(2007) Tanya Russell et al.   JOURNAL OF CLINICAL PHARMACOLOGY

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