Study Design Parameters Affecting Exposure Response Analysis of QT Data: Results From Simulation Studies-Reference-Cited by-同舟云学术

Study Design Parameters Affecting Exposure Response Analysis of QT Data: Results From Simulation Studies

Published:2018-02-08 Issue:5 Volume:58 Page:674-685
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Ferber Georg¹,Sun Yaning²,Darpo Borje³⁴,Garnett Christine⁵,Liu Jiang²

Affiliation:

1. Statistik Georg Ferber GmbH Riehen Switzerland

2. Division of Pharmacometrics Office of Clinical Pharmacology, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring MD USA

3. Karolinska Institutet Division of Cardiovascular Medicine Department of Clinical Sciences Danderyd's Hospital Stockholm Sweden

4. iCardiac Technologies Inc. Rochester NY USA

5. Division of Cardiovascular and Renal Products Office of New Drugs Center for Drug Evaluation and Research, US Food and Drug Administration Silver Spring MD USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.1065

Reference24 articles.

1. Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14

2. ICH E14 Questions & Answers (R3) December 10 2015.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Q_As_R3__Step4.pdf. Accessed January 10 2018.

3. ICH Harmonized Tripartite Guideline E14.The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non‐Antiarrhythmic Drugs. May2005.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Guideline.pdf. Accessed January 10 2018.

4. Concentration-QT Relationships Play a Key Role in the Evaluation of Proarrhythmic Risk During Regulatory Review

5. Statistical Issues Including Design and Sample Size Calculation in Thorough QT/QTc Studies

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