Time for a Fully Integrated Nonclinical–Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective-Reference-Cited by-同舟云学术

Time for a Fully Integrated Nonclinical–Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective

Published:2020-09-24 Issue:2 Volume:109 Page:310-318
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Vargas Hugo M.¹^ORCID,Rolf Michael G.²,Wisialowski Todd A.³,Achanzar William⁴,Bahinski Anthony⁵,Bass Alan⁶,Benson Charles T⁷,Chaudhary Khuram W.⁵,Couvreur Nicolas⁸,Dota Corina⁹,Engwall Michael J¹,Michael Foley C.¹⁰,Gallacher David¹¹,Greiter‐Wilke Andrea¹²,Guillon Jean‐Michel¹³,Guth Brian¹⁴,Himmel Herbert M.¹⁵,Hegele‐Hartung Christa¹⁵,Ito Maki¹⁶,Jenkinson Stephen¹⁷,Chiba Katsuyoshi¹⁸,Lagrutta Armando¹⁹,Levesque Paul⁴,Martel Eric¹⁴,Okai Yoshiko²⁰,Peri Ravikumar²¹,Pointon Amy²²,Qu Yusheng¹,Teisman Ard¹¹,Traebert Martin²³,Yoshinaga Takashi²⁴,Gintant Gary A.¹⁰,Leishman Derek J.⁷,Valentin Jean‐Pierre²⁵

Affiliation:

1. Translational Safety & Bioanalytical Sciences Amgen Research Thousand Oaks California USA

2. Research & Development, Clinical Pharmacology & Safety Sciences AstraZeneca Gothenburg Sweden

3. Global Safety Pharmacology Pfizer Global Research and Development Groton Connecticut USA

4. BMS Bristol‐Myers Squibb Company Princeton New Jersey USA

5. GlaxoSmithKline Collegeville Pennsylvania USA

6. Merck & Co., Inc. Boston Massachusetts USA

7. Eli Lilly and Company Indianapolis Indiana USA

8. Safety Pharmacology Institute de Recherches Servier Suresnes France

9. Research & Development, Chief Medical Officer Organization AstraZeneca Gothenburg Sweden

10. Integrative Pharmacology Abbvie, Inc North Chicago Illinois USA

11. Global Safety Pharmacology Janssen Research & Development Beerse Belgium

12. Roche Innovation Center Basel F. Hoffmann‐La Roche Ltd. Basel Switzerland

13. Sanofi R&D, Preclinical Safety Paris France

14. Department of Drug Discovery Sciences Boehringer Ingelheim Pharma GmbH & Co. KG Biberach an der Riss Germany

15. Safety Pharmacology Bayer AG Wuppertal Germany

16. Japan Pharmaceutical Manufacturers Association Tokyo Japan

17. Global Safety Pharmacology Pfizer Global Research and Development San Diego California USA

18. Medicinal Safety Research LaboratoriesDaiichi Sankyo Co., Ltd. Tokyo Japan

19. Merck & Co., Inc. West Point Pennsylvania USA

20. Takeda Pharmaceutical Company Ltd. Fujisawa Kanagawa Japan

21. Takeda Pharmaceutical Company Ltd. Cambridge Massachusetts USA

22. Research & Development, Clinical Pharmacology & Safety Sciences AstraZeneca Cambridge UK

23. Safety Pharmacology Novartis Institute of Biomedical Research Basel Switzerland

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

25. UCB Biopharma SPRL Braine‐l’Alleud Belgium

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2029

Reference61 articles.

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