Assessment of Multi‐Ion Channel Block in a Phase I Randomized Study Design: Results of the Ci PA Phase I ECG Biomarker Validation Study-Reference-Cited by-同舟云学术

Assessment of Multi‐Ion Channel Block in a Phase I Randomized Study Design: Results of the Ci PA Phase I ECG Biomarker Validation Study

Published:2019-01-18 Issue:4 Volume:105 Page:943-953
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Vicente Jose¹,Zusterzeel Robbert²,Johannesen Lars¹,Ochoa‐Jimenez Roberto²,Mason Jay W.³⁴,Sanabria Carlos⁴,Kemp Sarah⁴,Sager Philip T.⁵,Patel Vikram²,Matta Murali K.²,Liu Jiang²,Florian Jeffry¹,Garnett Christine¹,Stockbridge Norman¹,Strauss David G.²

Affiliation:

1. Office of New Drugs Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

2. Office of Clinical Pharmacology Office of Translational Science Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

3. Department of Medicine Division of Cardiology University of Utah Salt Lake City Utah USA

4. Spaulding Clinical Research West Bend Wisconsin USA

5. Stanford University Palo Alto California USA

Funder

U.S. Food and Drug Administration

U.S. Department of Energy

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1303

Reference46 articles.

1. International Council on Harmonisation.ICH topic S7B the nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals (2005).

2. International Council on Harmonisation.Guideline for industry E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non‐antiarrhythmic drugs (2005).

3. Early afterdepolarizations: mechanism of induction and block. A role for L-type Ca2+ current.

4. Mexiletine in the treatment of resistant ventricular arrhythmias: enhancement of efficacy and reduction of dose-related side effects by combination with quinidine.

5. Mexiletine-quinidine combination: Electrophysiologic correlates of a favorable antiarrhythmic interaction in humans

Cited by 70 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Chloroquine: Rapidly withdrawing from first-line treatment of COVID-19;Heliyon;2024-09

2. Assessment of corrected JT-peak (JTpc) and Tpeak-to-Tend (TpTec) as proarrhythmia biomarkers in non-human primates: Outcome from a HESI consortium;Journal of Pharmacological and Toxicological Methods;2024-09

3. The Current State of Realistic Heart Models for Disease Modelling and Cardiotoxicity;International Journal of Molecular Sciences;2024-08-24

4. An open-access database of lead-I ECG signals with practical variability scenarios;2024 IEEE 37th International Symposium on Computer-Based Medical Systems (CBMS);2024-06-26

5. Collaborative science in action: A 20 year perspective from the Health and Environmental Sciences Institute (HESI) Cardiac Safety Committee;Journal of Pharmacological and Toxicological Methods;2024-05