Evidence map›Paper›PMID 40437347›Full record

ArticlePharmaceutical research2025

Using Model Master Files to Support Oral Drug Product Development and Regulatory Submissions.

Yi-Hsien Cheng, Arindom Pal, Rebecca Moody, Tycho Heimbach, Viera Lukacova, Nikunjkumar Patel, Gregory Rullo, Yunming Xu, Tausif Ahmed, Essam Kerwash and 2 more

Abstract read
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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

12 authors.

Yi-Hsien ChengOffice 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, Maryland, USA.
Arindom PalOffice 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, Maryland, USA.
Rebecca MoodyOffice of Product Quality Assessment (OPQA), Office of Pharmaceutical Quality (OPQ), CDER, U.S. FDA, Silver Spring, Maryland, USA.
Tycho HeimbachPharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, New Jersey, USA.
Viera LukacovaSimulations Plus, Inc., 42505 10 th Street West, Lancaster, CA, 93534, USA.
Nikunjkumar PatelCertara Predictive Technologies Division, Sheffield, UK.
Gregory RulloRegulatory Excellence, Oncology R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Yunming XuOffice of Product Quality Assessment (OPQA), Office of Pharmaceutical Quality (OPQ), CDER, U.S. FDA, Silver Spring, Maryland, USA.
Tausif AhmedBiopharmaceutics Group, Global Clinical Management, Integrated Product Development Organization (IPDO), Dr. Reddy's Laboratories Ltd., Bachupally, Hyderabad, Telangana, India.
Essam KerwashMedicines and Healthcare Products Regulatory Agency (MHRA), 10 South Colonnade, Canary Wharf, London, E14 4PU, UK.
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, Maryland, 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, Maryland, USA. Fang.Wu@fda.hhs.gov.ORCID http://orcid.org/0009-0009-1485-8386

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This report summarizes the proceedings of Session 2 of the two-day public workshop titled "Considerations and Potential Regulatory Applications for a Model Master File" hosted by the U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) on May 2-3, 2024. The workshop aimed to discuss the frameworks and practical considerations for developing a model master file (MMF) and its applications to support drug product development and streamline regulatory review processes. This report provides a comprehensive and insightful overview of the second session of the workshop titled "MMF Applications for Oral Dosage Forms". The presentations, which included several case studies, covered potential frameworks and context of use (COU) of MMFs for oral drug products, practical considerations during model development, validation, and regulatory submission processes, as well as scientific justification for modification on approved MMFs. Additionally, the discussion highlighted the crucial role of global harmonization of MMFs, which can benefit both industry and regulatory authorities by making modeling more resource- and time-efficient while meeting high regulatory standards, ultimately reducing delays in drug development and accelerating the availability of new medicines. MMFs for oral dosage forms are especially advantageous due to the wealth of global resources from various organizations and the opportunity to extend these capabilities to complex generics. Lastly, the session also discussed the potential for using technology to track the lifecycle of accepted MMFs, enabling adaptations and ensuring transparency in their downstream reuse.

Indexed as

Drug ApprovalDrug DevelopmentDrugs, GenericAdministration, OralHumansPharmaceutical PreparationsUnited StatesUnited States Food and Drug AdministrationDrugs, GenericPharmaceutical Preparationsdrug product developmentmodeling and simulation (M&S)model master file (MMF)oral dosage formregulatory submission

Identifiers

PMID40437347

What OpenQuestion holds

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Registered trials

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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.