ITC Commentary on Metformin Clinical Drug-Drug Interaction Study Design That Enables an Efficacy- and Safety-Based Dose Adjustment Decision

Author:

Zamek-Gliszczynski Maciej J.1,Chu Xiaoyan2,Cook Jack A.3,Custodio Joseph M.4,Galetin Aleksandra5,Giacomini Kathleen M.6,Lee Caroline A.7,Paine Mary F.8,Ray Adrian S.9,Ware Joseph A.10,Wittwer Matthias B.11,Zhang Lei12,

Affiliation:

1. Quantitative Drug Disposition; GlaxoSmithKline plc; King of Prussia Pennsylvania USA

2. Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism; Merck & Co., Inc; Kenilworth New Jersey USA

3. Clinical Pharmacology, Global Product Development; Pfizer Inc.; Groton Connecticut USA

4. Clinical Pharmacology; Gilead Sciences Inc.; Foster City California USA

5. Centre for Applied Pharmacokinetic Research, School of Health Sciences; University of Manchester; Manchester UK

6. Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine; University of California; San Francisco California USA

7. Drug Metabolism and Clinical Pharmacology; DMPK Solutions; San Diego California USA

8. Department of Pharmaceutical Sciences, College of Pharmacy; Washington State University; Spokane Washington USA

9. Clinical Research; Gilead Sciences, Inc.; Foster City California USA

10. Clinical Pharmacology; Genentech; South San Francisco California USA

11. Roche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel; F. Hoffmann-La Roche Ltd; Basel Switzerland

12. Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration; Silver Spring; Maryland USA

Funder

National Institute of General Medical Sciences

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

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