Evidence map›Paper›PMID 40461748›Full record

ReviewPharmaceutical research2025

Adopting the Model Master File Framework to Enhance Modeling and Simulations Approaches for Regulatory Use.

Lanyan Fang, Eleftheria Tsakalozou, Fang Wu, Daniel Ritterbeck, Liang Zhao, Lei Zhang, Robert Lionberger

Abstract readReview
PubMed Publisher
In one paragraph

Review in Pharmaceutical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

7 authors.

Lanyan FangOffice of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA. lanyan.fang@fda.hhs.gov.ORCID http://orcid.org/0000-0001-5378-2948
Eleftheria TsakalozouOffice of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.
Fang WuOffice of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.
Daniel RitterbeckOffice of Generic Drug Policy (OGDP), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.
Liang ZhaoOffice of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.
Lei ZhangOffice of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.
Robert LionbergerOffice of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This overview summarizes the history and advancements of the modeling and simulation programs utilized in drug development and regulatory assessment, including the FDA's Model-Informed Drug Development (MIDD) Paired Meeting Program and the Model-Integrated Evidence (MIE) Meeting Pilot Between FDA and Generic Drug Applicants. The U.S. Food and Drug Administration's (FDA) recent notice concerning the use of the Type V Drug Master File (DMF) for Model Master File (MMF) submissions to support abbreviated new drug applications (ANDAs) encourages and facilitates model-sharing and model-reusability in drug development, supporting MIE programs using a broad range of quantitative models, including, but not limited to physiologically based pharmacokinetic (PBPK), population pharmacokinetics (PPK) and computational fluid dynamics (CFD) modeling. This overview also introduces the considerations and representative mock examples of MMFs discussed in the workshop titled "Considerations and Potential Regulatory Applications for a Model Master File (MMF)" co-hosted by the U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) on May 2-3, 2024. MMFs promote modeling and simulation approaches by reducing the burden of resources in developing this type of approaches for the pharmaceutical industry while increasing consistency and efficiency in regulatory assessments.

Indexed as

Computer SimulationDrug DevelopmentModels, BiologicalDrug ApprovalHumansUnited StatesUnited States Food and Drug Administrationdrug product developmentModel-Informed Drug Development (MIDD)Model-Integrated Evidence (MIE)Model Master File (MMF)regulatory assessment

Identifiers

PMID40461748

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.