Novel concentration‐QTc models for early clinical studies with parallel placebo controls: A simulation study-Reference-Cited by-同舟云学术

Novel concentration‐QTc models for early clinical studies with parallel placebo controls: A simulation study

Published:2020-12-08 Issue:2 Volume:20 Page:375-389
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Orihashi Yasushi¹^ORCID,Kumagai Yuji²,Shiosakai Kazuhito³

Affiliation:

1. Department of Clinical Pharmacology Tokai University School of Medicine Isehara Japan

2. Clinical Trial Center Kitasato University Hospital Sagamihara Japan

3. Data Intelligence Department Daiichi Sankyo Co., Ltd. Tokyo Japan

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2083

Reference26 articles.

1. ICH E14 Expert Working Group. The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non‐Antiarrhythmic Drugs E14.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Guideline.pdf. Published 2005.

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

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

4. Concentration-effect modeling based on change from baseline to assess the prolonging effect of drugs on QTc together with an estimate of the circadian time course

5. Detection of QTc Effects in Small Studies-Implications for Replacing the Thorough QT Study

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