Model Master File Framework: A Regulatory Path Advancing Modeling and Simulation Applications.

Authors

Eleftheria Tsakalozou, Rachel Erdman, Lei Zhang, Robert Lionberger, Lanyan Fang

Published in

Clinical and translational science. Volume 19. Issue 10. Pages e70703.

Abstract

To advance drug product development, regulatory decision making, and improve patient care, FDA has committed to the quantitative medicine paradigm that involves, among others, quantitative in silico methodologies and tools developed based on nonclinical, clinical, and real-world sources. In this Perspective, Model Master File (MMF) submissions as Type V Drug Master Files (DMF) are discussed as a path towards this commitment.

PMID:
42765768
Bibliographic data and abstract were imported from PubMed on 21 Sep 2026.

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