Design of the “Thorough QT Study”
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology
Reference3 articles.
1. Cardiac Repolarization and the Safety of New Drugs Defined by Electrocardiography
2. 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
3. Modeling and Interpreting QTc Prolongation in Clinical Pharmacology Studies
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1. A Phase 1 Clinical Study Evaluating the Effects of Cenobamate on the QT Interval;Clinical Pharmacology in Drug Development;2022-02-19
2. Concentration-Response Modeling of ECG Data From Early-Phase Clinical Studies as an Alternative Clinical and Regulatory Approach to Assessing QT Risk - Experience From the Development Program of Lemborexant;The Journal of Clinical Pharmacology;2016-08-04
3. Detection of QTc Effects in Small Studies-Implications for Replacing the Thorough QT Study;Annals of Noninvasive Electrocardiology;2014-11-04
4. Early Investigation of QTc Liability;Drug Safety;2012-09
5. Early clinical development: Evaluation of drug-induced torsades de pointes risk;Pharmacology & Therapeutics;2008-08
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