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[Session 4] Statistical Strategies for Early Phase QT Assessment
Session Chair(s)
Katsuyoshi Chiba, PhD
Senior Director and Head, Group III, Medicinal Safety Research Laboratories, R&D
Daiichi Sankyo Co., Ltd., Japan
Tadashi Koga, PhD
Research Support Department, Drug Safety Research Laboratories
Shin Nippon Biomedical Laboratories, Ltd., Japan
Speaker(s)
White Paper on Best Practices in Concentration-QTc Modelling
Christine E. Garnett, PharmD
FDA, United States
Associate Director, Pharmacometric Operations,OCP, CDER
Concentration-QT Analysis: How to Select the Best Model?
Georg Ferber
Statistik Georg Ferber GmbH, Switzerland
Statistical Consultant
Concentration-QT Analysis: How to Control False Positive and False Negative Rates
Georg Ferber
Statistik Georg Ferber GmbH, Switzerland
Statistical Consultant
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