Results From the IQ-CSRC Prospective Study Support Replacement of the Thorough QT Study by QT Assessment in the Early Clinical Phase-Reference-Cited by-同舟云学术

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

Published:2015-03-16 Issue:4 Volume:97 Page:326-335
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Darpo B¹²,Benson C³,Dota C⁴,Ferber G⁵,Garnett C⁶,Green CL⁷,Jarugula V⁸,Johannesen L⁹,Keirns J¹⁰,Krudys K¹¹,Liu J¹¹,Ortemann-Renon C¹²,Riley S¹³,Sarapa N¹⁴,Smith B²,Stoltz RR¹⁵,Zhou M²,Stockbridge N¹⁶

Affiliation:

1. Karolinska Institutet; Division of Cardiovascular Medicine, Department of Clinical Sciences, Danderyd's Hospital; Stockholm Sweden

2. iCardiac Technologies; Rochester New York USA

3. Lilly Corporate Center; Eli Lilly & Co.; Indianapolis Indiana USA

4. AstraZeneca R&D Mölndal; Mölndal Sweden

5. Statistik Georg Ferber; Riehen Switzerland

6. Certara; St. Louis Missouri USA

7. Duke Clinical Research Institute, Duke University Medical Center; Durham North Carolina USA

8. Drug Metabolism and Pharmacokinetics; Novartis Institute for Biomedical Research; East Hanover New Jersey USA

9. Division of Pharmacometrics, Office of Clinical Pharmacology, Center of Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA, and Department of Clinical Physiology, Karolinska Institutet; Karolinska University Hospital; Stockholm Sweden

10. Global Clinical Pharmacology & Exploratory Development; Astellas Pharma Global Development; Northbrook Illinois USA

11. Division of Pharmacometrics; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration; Silver Spring Maryland USA

12. Clinical and Exploratory Pharmacology; Sanofi; Bridgewater New Jersey USA

13. Clinical Pharmacology; Global Innovative Pharma Business, Pfizer; Groton Connecticut USA

14. Clinical Science, Bayer Healthcare; Whippany New Jersey USA

15. Covance Clinical Research Unit; Evansville Indiana USA

16. Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference46 articles.

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5. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Guideline.pdf 2014

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