Evidence map›Paper›PMID 42765768›Full record

ArticleClinical and translational science2026

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

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

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical and translational science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Eleftheria TsakalozouOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.ORCID https://orcid.org/0000-0003-1993-8528
Rachel ErdmanOffice of Generic Drug Policy, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.ORCID https://orcid.org/0009-0006-1447-2297
Lei ZhangOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.ORCID https://orcid.org/0000-0002-0639-3162
Robert LionbergerOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.ORCID https://orcid.org/0000-0002-0598-1771
Lanyan FangOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.ORCID https://orcid.org/0000-0001-5378-2948

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Computer SimulationDrug ApprovalHumansUnited StatesUnited States Food and Drug AdministrationDrug Master File (DMF)generic drugmodel‐integrated evidence (MIE)Model Master File (MMF)

Identifiers

PMID42765768
PMCPMC13592223

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.