General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy-Reference-Cited by-同舟云学术

General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy

Published:2019-11-10 Issue:1 Volume:107 Page:102-111
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Li Zhihua¹,Mirams Gary R.²,Yoshinaga Takashi³,Ridder Bradley J.¹,Han Xiaomei¹,Chen Janell E.⁴,Stockbridge Norman L.⁵,Wisialowski Todd A.⁶,Damiano Bruce⁷,Severi Stefano⁸,Morissette Pierre⁹,Kowey Peter R.¹⁰,Holbrook Mark¹¹,Smith Godfrey¹²¹³,Rasmusson Randall L.¹⁴,Liu Michael¹⁵,Song Zhen¹⁵,Qu Zhilin¹⁵,Leishman Derek J.¹⁶,Steidl‐Nichols Jill¹⁷,Rodriguez Blanca¹⁸,Bueno‐Orovio Alfonso¹⁹,Zhou Xin²⁰,Passini Elisa¹⁸,Edwards Andrew G.¹⁹,Morotti Stefano¹⁹,Ni Haibo¹⁹,Grandi Eleonora¹⁹,Clancy Colleen E.¹⁹,Vandenberg Jamie²⁰²¹,Hill Adam²⁰²¹,Nakamura Mikiko²²,Singer Thomas²³,Polonchuk Liudmila²³,Greiter‐Wilke Andrea²³,Wang Ken²³,Nave Stephane²⁴,Fullerton Aaron²⁵,Sobie Eric A.²⁶,Paci Michelangelo²⁷,Musuamba Tshinanu Flora²⁸²⁹,Strauss David G.¹

Affiliation:

1. Division of Applied Regulatory Science Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

2. Centre for Mathematical Medicine & Biology School of Mathematical Sciences University of Nottingham Nottingham UK

3. Global Cardiovascular Assessment Eisai Co., Ltd. Tokyo Japan

4. Division of Biometrics VI Office of Biostatistics Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

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

6. Global Safety Pharmacology Pfizer, Inc. Groton Connecticut USA

7. Global Safety Pharmacology/Nonclinical Safety Janssen Research & Development Raritan New Jersey USA

8. Department of Electrical, Electronic, and Information Engineering University of Bologna Cesena Italy

9. Department of Safety Assessment and Laboratory Animal Resources Merck & Co. Kenilworth New Jersey USA

10. Main Line Health and Sidney Kimmel Medical College Philadelphia Pennsylvania USA

11. Certara, Ltd. Sheffield UK

12. Clyde Biosciences Ltd Glasgow UK

13. Institute of Cardiovascular and Medical Sciences Glasgow University Glasgow UK

14. Department of Physiology and Biophysics Jacobs School of Medicine and Biomedical Sciences University at Buffalo Buffalo New York USA

15. Division of Cardiology Department of Medicine University of California, Los Angeles Los Angeles California USA

16. Department of Toxicology and Pathology Eli Lilly and Company Indianapolis Indiana USA

17. Covance Inc. Madison Wisconsin USA

18. Department of Computer Science University of Oxford Oxford UK

19. Department of Pharmacology University of California Davis Davis California USA

20. Victor Chang Cardiac Research Institute Darlinghurst New South Wales Australia

21. St Vincent's Clinical School UNSW Sydney Darlinghurst New South Wales Australia

22. Clinical Pharmacology Department Chugai Pharmaceutical Co., Ltd. Tokyo Japan

23. Roche Pharma Research and Early Development Pharmaceutical Sciences Roche Innovation Center Basel F. Hoffmann‐La Roche Ltd. Basel Switzerland

24. Roche Product Development, Safety Science/Licensing & Early Development F. Hoffmann‐La Roche Ltd. Basel Switzerland

25. Department of Safety Assessment Genentech, Inc. South San Francisco California USA

26. Icahn School of Medicine at Mount Sinai New York New York USA

27. BioMediTech Faculty of Medicine and Health Technology Tampere University Tampere Finland

28. Federal Agency for Medicines and Health Products Brussels Belgium

29. European Medicines Agency Amsterdam The Netherlands

Funder

Wellcome Trust

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1647

Reference76 articles.

1. Rechanneling the cardiac proarrhythmia safety paradigm: A meeting report from the Cardiac Safety Research Consortium

2. The Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative — Update on progress

3. Mechanistic Model-Informed Proarrhythmic Risk Assessment of Drugs: Review of the “CiPA” Initiative and Design of a Prospective Clinical Validation Study

4. Evolution of strategies to improve preclinical cardiac safety testing

5. Uncertainty Quantification Reveals the Importance of Data Variability and Experimental Design Considerations for in Silico Proarrhythmia Risk Assessment

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