Concentration-Response Modeling of ECG Data From Early-Phase Clinical Studies as an Alternative Clinical and Regulatory Approach to Assessing QT Risk - Experience From the Development Program of Lemborexant-Reference-Cited by-同舟云学术

Concentration-Response Modeling of ECG Data From Early-Phase Clinical Studies as an Alternative Clinical and Regulatory Approach to Assessing QT Risk - Experience From the Development Program of Lemborexant

Published:2016-08-04 Issue:1 Volume:57 Page:96-104
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Murphy Patricia J.¹,Yasuda Sanae²,Nakai Kenya²,Yoshinaga Takashi²,Hall Nancy¹,Zhou Meijian³,Aluri Jagadeesh¹,Rege Bhaskar¹,Moline Margaret¹,Ferry Jim¹,Darpo Borje³⁴

Affiliation:

1. Eisai Inc; Woodcliff Lake NJ USA

2. Eisai Co., Ltd; Bunkyo-ku Tokyo Japan

3. iCardiac Technologies; Rochester NY USA

4. Karolinska Institute; Stockholm Sweden

Funder

Eisai Inc.

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference22 articles.

1. ICH Harmonized Tripartite Guideline E14 The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs 2005 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Guideline.pdf

2. Design of the “Thorough QT Study.”;Darpo;Clin Pharmacol Ther,2008

3. Statistical issues including design and sample size calculation in thorough QT/QTc studies;Zhang;J Biopharm Stat,2008

4. Performance characteristics for some typical QT study designs under the ICH E-14 guidance;Hutmacher;J Clin Pharmacol,2008

5. Early QT assessment-how can our confidence in the data be improved?;Darpo;Br J Clin Pharmacol,2013

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