Operational Characteristics of Linear Concentration-QT Models for Assessing QTc Interval in the Thorough QT and Phase I Clinical Studies-Reference-Cited by-同舟云学术

Operational Characteristics of Linear Concentration-QT Models for Assessing QTc Interval in the Thorough QT and Phase I Clinical Studies

Published:2016-05-09 Issue:2 Volume:100 Page:170-178
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Garnett C¹,Needleman K²,Liu J³,Brundage R⁴,Wang Y³

Affiliation:

1. Division of Cardiovascular and Renal Products, Office of New Drugs, Center for Drug Evaluation and Research; FDA; Silver Spring Maryland USA

2. Office of the Commissioner; FDA; Silver Spring Maryland USA

3. Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research; FDA; Silver Spring Maryland USA

4. University of Minnesota, College of Pharmacy, Department of Experimental and Clinical Pharmacology; Minneapolis Minnesota USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference15 articles.

1. International Conference on Harmonisation Guideline for the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (E14) http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

2. Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review;Garnett;J. Clin. Pharmacol.,2008

3. International Conference on Harmonisation Questions & Answers (R3): The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (E14) http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

4. The IQ-CSRC prospective clinical phase 1 study: Can early QT assessment using exposure response analysis replace the thorough QT study;Darpo;A.N.E.,2014

5. Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase;Darpo;Clin. Pharmacol. Ther.,2015

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