Model Master File Framework: A Regulatory Path Advancing Modeling and Simulation Applications
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.
Authors
- Lanyan Fang (ORCID: https://orcid.org/0000-0001-5378-2948)
- Robert A. Lionberger (ORCID: https://orcid.org/0000-0002-0598-1771)
- Eleftheria Tsakalozou (ORCID: https://orcid.org/0000-0003-1993-8528)
- Lei Zhang (ORCID: https://orcid.org/0000-0002-0639-3162)
- Rachel Erdman (ORCID: https://orcid.org/0009-0006-1447-2297)
Institutions
- United States Food and Drug Administration (US)
- Center for Drug Evaluation and Research (US)
Publication Details
- Journal
- Clinical and Translational Science
- Published
- 2026-09-21
- DOI
- https://doi.org/10.1111/cts.70703
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 0.00