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

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Publication Details

Journal
Pharmaceutical Research
Published
2025-02-26
DOI
https://doi.org/10.1007/s11095-025-03823-5
Citations
1
Primary Topic
Safe Handling of Antineoplastic Drugs
Type
article
Field-Weighted Citation Impact
5.77
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article

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

Eleftheria Tsakalozou, Jessica Spires, James F. Clarke, Flora T. Musuamba et al.
1 citations
Pharmaceutical Research
Safe Handling of Antineoplastic Drugs
5.77
article

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

Eleftheria Tsakalozou, Jessica Spires, James F. Clarke, Flora T. Musuamba, Markus Fridén, Abdullah Hamadeh, Ming‐Liang Tan, Ross Walenga, Khondoker Alam, Jan De Backer, Sujatha Sonti, Jay Mowli
article en
1 citations

Abstract

No abstract available for this paper.
Pharmaceutical ResearchVol. 42(5)
United States Food and Drug Administration (US), Center for Drug Evaluation and Research (US), University of Namur (BE), University of Waterloo (CA), Fluidda (United States) (US), GlaxoSmithKline (United States) (US), AstraZeneca (Sweden) (SE), Simulations Plus (United States) (US)
Partnerships for the goals
Openalex Percentile: Top 8%
Safe Handling of Antineoplastic Drugs
5.77
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Regulatory and Industry Perspective on the Model Master File Framework for Locally Acting Drug Products — Eleftheria Tsakalozou, Jessica Spires, et al. · Pharmaceutical Research (2025) | TGRS Research Map | TGRS