Incorporating exposure-response modeling into the assessment of QTc interval: A potential alternative to the thorough QT study
Author:
Affiliation:
1. Cardiovascular Global Clinical Development; Merck and Co., Inc. Rapporteur, ICH E14 Working Group
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Reference7 articles.
1. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Guideline.pdf
2. The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies;Bouvy;Clin. Pharmacol. Ther.,2012
3. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_QAs_R2_Step4.pdf
4. 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;Chapel;Clin. Pharmacol. Ther.,2011
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