Weaning off Thorough <scp>QT</scp> Studies-Reference-Cited by-同舟云学术

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Weaning off Thorough QT Studies

Published:2024-06-16 Issue:1 Volume:116 Page:11-13
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Mehanna Mai¹,van der Graaf Piet H.²³

Affiliation:

1. Division of Applied Regulatory Sciences (DARS), Office of Clinical Pharmacology (OCP)/Office of Translational Sciences (OTS)/Center for Drug Evaluation and Research (CDER) U.S. FDA Silver Spring Maryland USA

2. Certara, Applied BioSimulation Canterbury UK

3. Leiden Academic Centre for Drug Research Leiden The Netherlands

Publisher

Wiley

Link

https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.3294

Reference8 articles.

1. Toward Replacement of Thorough QT Studies

2. ICH E14/S7B draft guideline: clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential question and answers (2020) Accessed April 17 2024.

3. Time for a Fully Integrated Nonclinical–Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective

4. Should you run a dedicated TQT study? Sponsor and regulatory considerations on substitution pathways to assess QT liability;Lester R.M.;Clin. Pharmacol. Ther.,2024

5. Results from a joined prospective study to evaluate the sensitivity of the in vivo dog QT assay in line with the ICH E14/S7B Q&a best practices;Betat A.M.;Clin. Pharmacol. Ther.,2024

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