The Committee will discuss strategies, approaches, and challenges in model-informed drug development (MIDD) with specific focus on two areas. During the morning session, the Committee will discuss approaches and evidentiary information needed for applying physiologically-based pharmacokinetic modeling and simulation throughout a drug’s lifecycle. During the afternoon session, the Committee will discuss mechanistic model informed safety evaluation with a focus on drug potential for causing arrhythmias. The Comprehensive in Vitro Proarrhythmia Assay will be discussed as an exemplar.

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