The use of model-informed drug development (MIDD) for new and generic drugs has significantly increased over the past several years. The Committee will discuss strategies, approaches, and challenges in 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.

See the FDA Announcement