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; Liang Zhao

doi:10.1007/s11095-025-03839-x

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

Pharm Res. 2025 May;42(5):737-746. doi: 10.1007/s11095-025-03839-x. Epub 2025 Mar 7.

Authors

Eleftheria Tsakalozou¹, Lanyan Fang², Erin Skoda³, Timothy Nicholas⁴, Sivacharan Kollipara⁵, Ke Ren⁶, Stella Grosser⁷, Bhagwant Rege⁸, Partha Roy⁶, Hao Zhu⁹, Liang Zhao²

Affiliations

¹ Division 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.
² Division 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.
³ Office 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.
⁴ Pfizer Inc., Cambridge, MA, USA.
⁵ Biopharmaceutics Group, Global Clinical Management, Integrated Product Development Organization (IPDO), Dr. Reddy's Laboratories Ltd, Bachupally, Medchal Malkajgiri District, Hyderabad, 500 090, Telangana, India.
⁶ Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
⁷ Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
⁸ Office 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.
⁹ Office 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.

Abstract

Supplementary Information: The online version contains supplementary material available at 10.1007/s11095-025-03839-x.

Keywords: model master file; modeling and simulation; workshop report.

Abstract

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