The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has announced the establishment of a new quantitative medicine (QM) Center of Excellence to promote the uptake of modeling and simulation approaches in drug development and assessment.
The agency defines QM as “the application of exposure-based, biological, and quantitative modeling and simulation approaches derived from nonclinical, clinical, and real-world sources to inform drug development, regulatory decision-making, and patient care.”
FDA told Focus that the center builds on existing quantitative approaches to facilitate drug development and review, such as model-informed drug development (MIDD), complex innovative trial design (CID), and the Fit-for-Purpose initiative…
