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Pharmaceutical Science and Clinical Pharmacology Advisory Committee

The use of model-informed drug development (MIDD) for new and generic drugs has significantly increased over the past several years. The Committee discussed strategies, approaches, and challenges in MIDD with specific focus on two areas. During the morning session, the Committee discussed approaches and evidentiary information needed for applying physiologically-based pharmacokinetic modeling and simulation throughout a drug’s lifecycle. During the afternoon session, the Committee discussed mechanistic model informed safety evaluation with a focus on drug potential for causing arrhythmias. The Comprehensive in Vitro Proarrhythmia Assay was discussed as an exemplar.