Evidence map›Paper›PMID 40055245›Full record

ArticlePharmaceutical research2025

Considering Opportunities and Challenges When Implementing the Model Master File Framework - a Meeting Report.

Eleftheria Tsakalozou, Lanyan Fang, Erin Skoda, Timothy Nicholas, Sivacharan Kollipara, Ke Ren, Stella Grosser, Bhagwant Rege, Partha Roy, Hao Zhu and 1 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. 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

11 authors.

Eleftheria TsakalozouDivision of Quantitative Methods and Modeling, Office 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, 20993, USA. Eleftheria.Tsakalozou@fda.hhs.gov.ORCID http://orcid.org/0000-0003-1993-8528
Lanyan FangDivision of Quantitative Methods and Modeling, Office 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, 20993, USA.
Erin SkodaOffice of Product Quality Assessment III, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER), U. S. Food and Drug Administration (FDA), Silver Spring, MD, USA.
Timothy NicholasPfizer Inc., Cambridge, MA, USA.
Sivacharan KolliparaBiopharmaceutics Group, Global Clinical Management, Integrated Product Development Organization (IPDO), Dr. Reddy's Laboratories Ltd, Bachupally, Medchal Malkajgiri District, Hyderabad, 500 090, Telangana, India.
Ke RenOffice of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Stella GrosserOffice of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Bhagwant RegeOffice of Product Quality Assessment I, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, 20903-1058, USA.
Partha RoyOffice of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Hao ZhuOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.
Liang ZhaoDivision of Quantitative Methods and Modeling, Office 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, 20993, USA.

Funding

FDA HHS U18 FD007054U.S. Food and Drug Administration U18FD007054
6 · The paper itself

Abstract

PubMed holds no abstract for this paper.

Indexed as

modeling and simulationmodel master fileworkshop report

Identifiers

PMID40055245
PMCPMC12158848

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.