Translational Models and Tools to Reduce Clinical Trials and Improve Regulatory Decision Making for QTc and Proarrhythmia Risk (ICH E14/S7B Updates)-Reference-Cited by-同舟云学术

Translational Models and Tools to Reduce Clinical Trials and Improve Regulatory Decision Making for QTc and Proarrhythmia Risk (ICH E14/S7B Updates)

Published:2021-01-07 Issue:2 Volume:109 Page:319-333
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Strauss David G.¹,Wu Wendy W.¹,Li Zhihua¹,Koerner John²,Garnett Christine³

Affiliation:

1. Division of Applied Regulatory Science Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

2. Division of Pharm/Tox for Cardiology, Hematology, Endocrinology and Nephrology Office of Cardiology, Hematology, Endocrinology and Nephrology Office of New Drugs Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

3. Division of Cardiology and Nephrology Office of Cardiology, Hematology, Endocrinology and Nephrology Office of New Drugs Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2137

Reference84 articles.

1. ICH E14/S7B draft guideline: clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential question and answers (2020). Accessed November 25 2020.

2. E14 and S7B clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential questions and answers draft guidance for industry (2020). Accessed November 25 2020.

3. New approaches for an integrated nonclinical‐clinical QT/proarrhythmic risk assessment (2020). Accessed November 25 2020.

4. Time for a fully integrated nonclinical‐clinical risk assessment to streamline QT prolongation liability determinations: a pharma industry perspective;Vargas H.M.;Clin. Pharmacol. Ther.,2021

5. ICH E14/S7B Implementation Working Group Final Concept Paper (2018). Accessed November 25 2020.

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