Improving the in vivo QTc assay: Nonclinical concentration-QTc modeling for risk assessment

Author:

Wisialowski Todd A.,Ether Nick,Foley C. Michael,Kleiman Robert,Koshman Yevgeniya,Leishman Derek,Martel Eric,Nichols Jill V.,Popp Julia,Rajamani Sridharan,Riley Steve,Rossman Eric I.,Vargas Hugo M.

Publisher

Elsevier BV

Reference22 articles.

1. ICH E14/S7B Implementation Working Group: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Questions and Answers;Anonymous,2022

2. ICH E14/S7B implementation working group: E14/S7B questions and answers: Clinical and nonclinical evaluation of QT/QTc interval prolongation and Proarrhythmic potential;Anonymous;Training Materials.,2022

3. Evaluation of moxifloxacin in canine and non-human primate telemetry assays: Comparison of QTc interval prolongation by timepoint and concentration-QTc analysis;Chui;Clinical and Translational Science,2021

4. Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase;Darpo;Clinical Pharmacology and Therapeutics,2015

5. The IQ-CSRC prospective clinical phase 1 study: “can early QT assessment using exposure response analysis replace the thorough QT study?”;Darpo;Annals of Noninvasive Electrocardiology,2014

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1. Innovative approaches to cardiovascular safety pharmacology assessment;Journal of Pharmacological and Toxicological Methods;2024-07

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