Model Master File Framework: A Regulatory Path Advancing Modeling and Simulation Applications.
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| Title: | Model Master File Framework: A Regulatory Path Advancing Modeling and Simulation Applications. |
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| Authors: | Tsakalozou E; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Erdman R; Office of Generic Drug Policy, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Zhang L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Lionberger R; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Fang L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA. |
| Source: | Clinical and translational science [Clin Transl Sci] 2026 Oct; Vol. 19 (10), pp. e70703. |
| Publication Type: | Journal Article |
| Journal Info: | Publisher: WileyBlackwell Pub Country of Publication: United States NLM ID: 101474067 Publication Model: Print Cited Medium: Internet ISSN: 1752-8062 (Electronic) Linking ISSN: 17528054 NLM ISO Abbreviation: Clin Transl Sci Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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| ISSN: | 1752-8062 |
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| DOI: | 10.1111/cts.70703 |
