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

Year: 2025

Type: article

Abstract: Graphical Abstract

Source: Pharmaceutical Research

DOI: 10.1007/s11095-025-03839-x

Authors: Eleftheria Tsakalozou, Lanyan Fang, Erin Skoda, Timothy Nicholas, Sivacharan Kollipara, Ke Ren, Stella Grosser, Bhagwant Rege, Partha Roy, Hao Zhu, Liang Zhao

Institutions: United States Food and Drug Administration, Center for Drug Evaluation and Research, Pfizer (United States), Dr. Reddy's Laboratories (India)

Language: English

Topic: Pharmaceutical Economics and Policy

Subfield: Economics and Econometrics

Field: Economics, Econometrics and Finance

Domain: Social Sciences

Open Access status: hybrid

Estimated APC paid: $4,690

Funder: U.S. Food and Drug Administration

Award: G4186222243

OpenAlex ID: W4408212823

FWCI:

Cites: 27

Cited by:

Related to: 10