New CDER Conversation: Model Informed Drug Development - Drug Information Update

Talking with Raj Madabushi, Ph.D., Team Leader, Guidance and Policy Team, Office of Translational Sciences, Office of Clinical Pharmacology, CDER.

Model-informed drug development (MIDD) is an approach that involves developing and applying exposure-based, biological and statistical models derived from preclinical and clinical data sources to inform drug development and decision-making. It aims to integrate information from diverse data sources to help decrease uncertainty and lower failure rates, and to develop information that cannot or would not be generated experimentally1. Integrating MIDD into more drug applications and advancing its use are some of FDA’s goals under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI).

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