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Model Integrated Evidence as Pivotal Information for Drug Regulatory Decision Making: When, Where, and Why
Session Chair(s)
Liang Zhao, PhD
Director, Division of Quantitative Methods and Modeling, OGD, CDER
FDA, United States
The use of advanced quantitative methods and computational modeling has become part of modern drug development and assessment. Model Integrated Evidence (MIE) is an approach for generating evidence of bioequivalence via modeling and simulation.
Learning Objective : Identify the core modeling and simulation capabilities (PBPK and QCP) that a generic drug manufacturer must posses; Evaluate lessons learned from the use of a model informed drug development process for new drugs, and apply common processes to generic drug development programs; Define and prepare for the future use of model informed evidence (MIE) in a generic drug submission and identify the value.
Speaker(s)
Industry Update
Michael A. Eldon, PhD, RPh
NDA Partners LLC, United States
Expert Consultant
FDA Update From New Drugs Perspective
Yaning Wang, PhD
FDA, United States
Director, Division of Pharmacometrics, OCP, OTS, CDER
FDA Update from Generic Drugs Perspective
Liang Zhao, PhD
FDA, United States
Director, Division of Quantitative Methods and Modeling, OGD, CDER
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