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.
Citations
1 citations
Journal
Pharmaceutical Research
Topics
Safe Handling of Antineoplastic Drugs
Field-Weighted Citation Impact (FWCI)
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.
Publication Tag
Pharmaceutical ResearchVol. 42(5)
Institutions
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)
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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