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Pharmacometric Methods: Essential for Optimal Drug Development Strategy
Session Chair(s)
Royce A. Morrison, MD, MS, FACP
Senior Consultant
Pacific Pharma Group, LLC, United States
This session will explore the definition of pharmacometrics, its key role in strategy, program planning, study design, labeling and regulatory decision-making, and its rapidly developed implementation by regulatory agencies.
Learning Objective : Define pharmacometrics and describe examples of its application across the range of drug development and decision-making activities; Explain the need for all decision-makers in drug development to know how and when to implement pharmacometric methods.
Speaker(s)
Clinical Implications of Population Pharmacokinetics of rFIXFc in Management of Hemophilia B
Haiyan Jiang, PhD
Biogen Idec, United States
Senior Director, Preclinical and Clinical Research (Hemophilia)
Seeing into the Future: The Prasugrel Story of Pharmacometric Support for Dose Adjustments in Higher-risk Subgroups
David S. Small, PhD
Eli Lilly and Company, United States
Research Advisor, Global Pharmacokinetics/Pharmacodynamics
Impact of Pharmacometrics on Pediatric Drug Development
Amit Roy
Bristol-Myers Squibb Company, United States
Group Director, Clinical Pharmacology and Pharmacometrics R&D
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