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

Author:

Valade Elodie,Dosne Anne-Gaëlle,Xie Hong,Kleiman RobertORCID,Li Lilian Y.,Perez-Ruixo Juan JoséORCID,Ouellet Daniele

Funder

Janssen Research & Development, LLC, USA

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Cancer Research,Pharmacology,Toxicology,Oncology

Reference23 articles.

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2. Chapel S, Hutmacher MM, Bockbrader H, de Greef R, Lalonde RL (2011) 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. Clin Pharmacol Ther 89(1):75–80. https://doi.org/10.1038/clpt.2010.220

3. Darpo B, Benson C, Dota C, Ferber G, Garnett C, Green CL, Jarugula V, Johannesen L, Keirns J, Krudys K, Liu J, Ortemann-Renon C, Riley S, Sarapa N, Smith B, Stoltz RR, Zhou M, Stockbridge N (2015) Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase. Clin Pharmacol Ther 97(4):326–335. https://doi.org/10.1002/cpt.60

4. Darpo B, Garnett C, Benson CT, Keirns J, Leishman D, Malik M, Mehrotra N, Prasad K, Riley S, Rodriguez I, Sager P, Sarapa N, Wallis R (2014) 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. Am Heart J 168(3):262–272. https://doi.org/10.1016/j.ahj.2014.06.003

5. Darpo B, Nebout T, Sager PT (2006) Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs: the international conference on harmonization of technical requirements for registration of pharmaceuticals for human Use E14 guideline. J Clin Pharmacol 46(5):498–507. https://doi.org/10.1177/0091270006286436

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