Evidence map›Paper›PMID 40011371›Full record

ArticlePharmaceutical research2025

Regulatory and Industry Perspective on the Model Master File Framework for Locally Acting Drug Products.

Ross L Walenga, Khondoker Alam, James F Clarke, Jan De Backer, Markus Fridén, Abdullah Hamadeh, Jay Mowli, Sujatha Sonti, Jessica Spires, Ming-Liang Tan and 2 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article 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. AI-powered in silico twins: redefining precision medicine through simulation, personalization, and predictive healthcare.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2025
    Review
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

12 authors.

Ross L WalengaDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak Building 75, Room 4700, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Ross.Walenga@fda.hhs.gov.
Khondoker AlamDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak Building 75, Room 4700, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
James F ClarkeCertara Predictive Technologies Division, Certara UK, Sheffield, UK.
Jan De BackerFLUIDDA INC., New York, NY, USA.
Markus FridénInhalation Product Development, Pharmaceutical Technology & Development, AstraZeneca, Gothenburg, Sweden.
Abdullah HamadehUniversity of Waterloo, Waterloo, Canada.
Jay MowliCapstone Development Services Co, LLC, Rosemont, IL, USA.
Sujatha SontiGSK, Collegeville, PA, USA.
Jessica SpiresSimulations Plus, Inc., Lancaster, CA, USA.
Ming-Liang TanDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak Building 75, Room 4700, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
Flora T MusuambaClinical Pharmacology and Toxicology Research Unit, University of Namur, Namur, Belgium.
Eleftheria TsakalozouDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak Building 75, Room 4700, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PubMed holds no abstract for this paper.

Indexed as

computational fluid dynamics (CFD)locally acting drug productsmodel master filephysiologically based pharmacokinetic (PBPK)

Identifiers

PMID40011371
PMCPMC12158826

What OpenQuestion holds

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LicenceCC BY
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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.