{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T17:50:04Z","timestamp":1792173004760,"version":"4.4.0"},"reference-count":10,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T00:00:00Z","timestamp":1789948800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T00:00:00Z","timestamp":1789948800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>To advance drug product development, regulatory decision making, and improve patient care, FDA has committed to the quantitative medicine paradigm that involves, among others, quantitative in silico methodologies and tools developed based on nonclinical, clinical, and real\u2010world sources. In this Perspective, Model Master File (MMF) submissions as Type V Drug Master Files (DMF) are discussed as a path towards this commitment.<\/jats:p>","DOI":"10.1111\/cts.70703","type":"journal-article","created":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T13:12:14Z","timestamp":1789996334000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Model Master File Framework: A Regulatory Path Advancing Modeling and Simulation Applications"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1993-8528","authenticated-orcid":false,"given":"Eleftheria","family":"Tsakalozou","sequence":"first","affiliation":[{"name":"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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-1447-2297","authenticated-orcid":false,"given":"Rachel","family":"Erdman","sequence":"additional","affiliation":[{"name":"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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0639-3162","authenticated-orcid":false,"given":"Lei","family":"Zhang","sequence":"additional","affiliation":[{"name":"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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0598-1771","authenticated-orcid":false,"given":"Robert","family":"Lionberger","sequence":"additional","affiliation":[{"name":"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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5378-2948","authenticated-orcid":false,"given":"Lanyan","family":"Fang","sequence":"additional","affiliation":[{"name":"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"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,21]]},"reference":[{"key":"e_1_2_5_2_1","unstructured":"U.S. Food and Drug Administration \u201cFederal Register Notice: Establishment of a Public Docket: Use of a Type V Drug Master File for Model Master File Submissions to Support Abbreviated New Drug Applications \u201d(2026) https:\/\/www.govinfo.gov\/content\/pkg\/FR\u20102025\u201001\u201017\/pdf\/2025\u201001182.pdf."},{"key":"e_1_2_5_3_1","unstructured":"U.S. Food and Drug Administration \u201cGuidance for Industry: M15 General Principles for Model\u2010Informed Drug Development \u201d(2026) https:\/\/www.fda.gov\/media\/184747\/download."},{"key":"e_1_2_5_4_1","unstructured":"\u201cFDA and the Center for Research on Complex Generics (CRCG) Co\u2010Hosted Workshop: Considerations and Potential Regulatory Applications for a Model Master File \u201d(2024) https:\/\/www.complexgenerics.org\/education\u2010training\/considerations\u2010and\u2010potential\u2010regulatory\u2010applications\u2010for\u2010a\u2010model\u2010master\u2010file\/."},{"key":"e_1_2_5_5_1","unstructured":"Pharmaceutical Research \u201cThemed Issue: FDA Modeling Master File \u201d(2026) https:\/\/link.springer.com\/collections\/ahbfbhjjjg."},{"key":"e_1_2_5_6_1","unstructured":"FDA \u201cGuidance for Industry. Drug Master Files \u201d(2019) https:\/\/www.fda.gov\/media\/131861\/download."},{"key":"e_1_2_5_7_1","volume-title":"Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions","author":"FDA\/CDER and Small Business & Industry Aassistance","year":"2025"},{"key":"e_1_2_5_8_1","unstructured":"European Medicines Agency \u201cQualification of Novel Methodologies for Medicine Development \u201d(2026) https:\/\/www.ema.europa.eu\/en\/human\u2010regulatory\u2010overview\/research\u2010development\/scientific\u2010advice\u2010protocol\u2010assistance\/qualification\u2010novel\u2010methodologies\u2010medicine\u2010development."},{"key":"e_1_2_5_9_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-024-00897-8"},{"key":"e_1_2_5_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11095-025-03861-z"},{"key":"e_1_2_5_11_1","unstructured":"American Conference of Pharmacometrics 2025 \u201cFDA's Model Master Files: Paving the Path for Innovative Technologies and Increased Regulatory Acceptance of Modeling and Simulation Approaches \u201d(2026) https:\/\/acop2025.eventscribe.net\/fsPopup.asp?Mode=sessioninfo&PresentationID=1648346."}],"container-title":["Clinical and Translational Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.70703","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/cts.70703","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.70703","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T17:17:47Z","timestamp":1792171067000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1111\/cts.70703"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,21]]},"references-count":10,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2026,10]]}},"alternative-id":["10.1111\/cts.70703"],"URL":"https:\/\/doi.org\/10.1111\/cts.70703","archive":["Portico"],"relation":{},"ISSN":["1752-8054","1752-8062"],"issn-type":[{"value":"1752-8054","type":"print"},{"value":"1752-8062","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,21]]},"assertion":[{"value":"2026-05-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-03","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-21","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70703"}}