Drug development model's opportunities and challenges outlined by CDER official

Mindful that integrating model-informed drug development (MIDD) into more drug applications and advancing its use are the US Food and Drug Administration’s (FDA) goals under the Prescription Drug User Fee Amendments of 2017, the agency has stepped up its publicizing of the potential benefits to drugmakers.

Raj Madabushi, team leader of the guidance and policy team for the Office of Translational Sciences, Office of Clinical Pharmacology at the Center for Drug Evaluation and Research, has spoken about the opportunities that MIDD offers.

MIDD involves developing and applying exposure-based, biological and statistical models derived from preclinical and clinical data sources to inform drug development and decision-making.