Individual-Specific QT Interval Correction for Drugs With Substantial Heart Rate Effect Using Holter ECGs Extracted Over a Wide Range of Heart Rates-Reference-Cited by-同舟云学术

Individual-Specific QT Interval Correction for Drugs With Substantial Heart Rate Effect Using Holter ECGs Extracted Over a Wide Range of Heart Rates

Published:2018-05-18 Issue:8 Volume:58 Page:1013-1019
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Panicker Gopi Krishna¹,Kadam Pramod¹,Chakraborty Saikat¹,Kothari Snehal²,Turner J. Rick³,Karnad Dilip R.¹

Affiliation:

1. Cardiac Safety Services; IQVIA; Mumbai India

2. Lilavati Hospital & Research Centre; Mumbai India

3. Campbell University College of Pharmacy & Health Sciences; Buies Creek NC USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference16 articles.

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3. ICH. E14 Implementation Working Group ICH E14 Guideline: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs: Questions & Answers (R3) 2015 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Q_As_R3__Step4.pdf

4. 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

5. Incorporating exposure-response modeling into the assessment of QTc interval: a potential alternative to the thorough QT study;Bloomfield;Clin Pharmacol Ther,2015

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