The IQ-CSRC Prospective Clinical Phase 1 Study: “Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?”

Author:

Darpo Borje1,Sarapa Nenad2,Garnett Christine3,Benson Charles4,Dota Corina5,Ferber Georg6,Jarugula Venkateswar7,Johannesen Lars89,Keirns James10,Krudys Kevin11,Ortemann-Renon Catherine12,Riley Steve13,Rogers-Subramaniam Danise4,Stockbridge Norman14

Affiliation:

1. Karolinska Institutet; Division of Cardiovascular Medicine; Department of Clinical Sciences; Danderyd's Hospital; Stockholm; Sweden and iCardiac Technologies; Rochester NY

2. Clinical Science; Bayer Healthcare; Inc. Whippany NJ

3. Certara; St. Louis MO

4. Lilly Corporate Center; Eli Lilly & Co; Indianapolis IN

5. AstraZeneca R&D Mölndal; Mölndal Sweden

6. Statistik Georg Ferber GmbH; CH-4125 Riehen Switzerland

7. Drug Metabolism and Pharmacokinetics; Novartis Institute for Biomedical Research; East Hanover NJ

8. Division of Pharmacometrics; Office of Clinical Pharmacology; Center of Drug Evaluation and Research; US Food and Drug Administration; Silver Spring MD

9. Department of Clinical Physiology; Karolinska Institute; Karolinska University Hospital; Stockholm Sweden

10. Global Clinical Pharmacology & Exploratory Development; Astellas Pharma Global Development, Inc; Northbrook IL

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

12. Clinical and Exploratory Pharmacology; Sanofi; Bridgewater NJ

13. Clinical Pharmacology; Specialty Care Business Unit; Pfizer Inc. Groton CT

14. Division of Cardiovascular and Renal Products; Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring MD

Publisher

Wiley

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine,General Medicine

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