ECG Evaluation as Part of the Clinical Pharmacology Strategy in the Development of New Drugs: A Review of Current Practices and Opportunities Based on Five Case Studies-Reference-Cited by-同舟云学术

ECG Evaluation as Part of the Clinical Pharmacology Strategy in the Development of New Drugs: A Review of Current Practices and Opportunities Based on Five Case Studies

Published:2022-07 Issue:12 Volume:62 Page:1480-1500
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharma

Author:

Darpo Borje¹,Borin Marie²,Ferber Georg³,Galluppi Gerald R.⁴,Hopkins Seth C.⁴,Landry Ishani⁵,Lo Arthur²,Rege Bhaskar⁶,Reyderman Larisa⁵,Sun Lei⁶,Watanabe Takao⁴,Xue Hongqi¹,Yasuda Sally⁵

Affiliation:

1. Clario Rochester New York USA

2. Clinical and Translational Pharmacology Theravance Biopharma US, Inc. South San Francisco California USA

3. Statistik Georg Ferber GmbH Riehen Switzerland

4. Sunovion Pharmaceuticals, Inc. Marlborough Massachusetts USA

5. Clinical Pharmacology and Translational Medicine Eisai Nutley New Jersey USA

6. Alkermes, Inc. Waltham Massachusetts USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.2095

Reference31 articles.

1. ICH E14.The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for nonantiarrhythmic drugs.https://www.ich.org/page/efficacy-guidelines. Accessed June 27 2022.

2. ICH E14.Questions & Answers (R3)December 10 2015.https://www.ich.org/page/efficacy‐guidelines. Accessed June 27 2022.

3. Early QT assessment - how can our confidence in the data be improved?

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

5. Results From the IQ-CSRC Prospective Study Support Replacement of the Thorough QT Study by QT Assessment in the Early Clinical Phase

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