Comparison of QTc Data Analysis Methods Recommended by the ICH E14 Guidance and Exposure–Response Analysis: Case Study of a Thorough QT Study of Asenapine-Reference-Cited by-同舟云学术

Comparison of QTc Data Analysis Methods Recommended by the ICH E14 Guidance and Exposure–Response Analysis: Case Study of a Thorough QT Study of Asenapine

Published:2010-11-24 Issue:1 Volume:89 Page:75-80
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:
Short-container-title:Clin Pharmacol Ther

Author:

Chapel S,Hutmacher M M,Bockbrader H,de Greef R,Lalonde R L

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference9 articles.

1. 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

2. Exposure-Response Analysis in Patients With Schizophrenia to Assess the Effect of Asenapine on QTc Prolongation

3. Performance Characteristics for Some Typical QT Study Designs Under the ICH E-14 Guidance

4. A Perspective on the Use of Concentration-QT Modeling in Drug Development

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