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Pharmacometrics: Implications and Impact in Preclinical to Early Phase Clinical Development
Session Chair(s)
Royce A. Morrison, MD, MS, FACP
Senior Consultant
Pacific Pharma Group, LLC, United States
Increasingly, sponsors' and regulators' decisions in drug programs are being driven by pharmacometric methods. Early phase trials will change to give the right range of data for physiologically- and pharmacologically-based modeling and simulations.
Learning Objective : Discuss pharmacometrics as a discipline in drug development and regulatory decision-making; Explain the range and impact of pharmacometric methods in preclinical, translational and early-phase clinical development; Discuss when to collaborate and consult to apply methods to program and study design.
Speaker(s)
Pharmacometrics Drives Drug Approval and Labeling Decisions
Jogarao V. Gobburu, PhD, MBA
Vivpro Corp, United States
President
Pharmacometrics Impacts Drug Development Decisions: Big Pharma Experience
Arnab Mukherjee
Pfizer Inc, United States
Director, Specialty Care Clinical Pharmacology
Opportunities to Take Advantage of Pharmacometrics
Royce A. Morrison, MD, MS, FACP
Pacific Pharma Group, LLC, United States
Senior Consultant
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