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Teratogenic Risk Impact and Mitigation (TRIM): Study Protocol for the Development of a Decision Support Tool to Prioritize Medications for Risk Mitigation.

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Title: Teratogenic Risk Impact and Mitigation (TRIM): Study Protocol for the Development of a Decision Support Tool to Prioritize Medications for Risk Mitigation.
Authors: Winterstein AG; Department of Pharmaceutical Outcomes and Policy, University of Florida, Gainesville, FL, USA. almut@ufl.edu.; Center for Drug Evaluation and Safety, University of Florida, Gainesville, FL, USA. almut@ufl.edu.; Department of Epidemiology, University of Florida, Gainesville, FL, USA. almut@ufl.edu., Ewig CLY; Department of Pharmaceutical Outcomes and Policy, University of Florida, Gainesville, FL, USA., Wang Y; Department of Pharmaceutical Outcomes and Policy, University of Florida, Gainesville, FL, USA.; Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL, USA., Smolinski NE; Department of Pharmaceutical Outcomes and Policy, University of Florida, Gainesville, FL, USA., Toyserkani GA; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., LaCivita C; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Lackey L; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Eggers S; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Zhou EH; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Diaby V; Health Economics and Value Evidence Partnership, Otsuka Pharmaceutical Development Corporation Inc, Princeton, NJ, USA., Sarayani A; Janssen Research and Development, Johnson & Johnson, Brisbane, CA, USA., Thai T; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA., Maro JC; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA., Rasmussen SA; Department of Genetic Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Source: Drug safety [Drug Saf] 2025 Feb; Vol. 48 (2), pp. 107-117. Date of Electronic Publication: 2024 Nov 05.
Publication Type: Journal Article
Journal Info: Publisher: Adis, Springer International Country of Publication: New Zealand NLM ID: 9002928 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1179-1942 (Electronic) Linking ISSN: 01145916 NLM ISO Abbreviation: Drug Saf Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="AU" term="%22Winterstein+AG%22">Winterstein AG</searchLink>; Department of Pharmaceutical Outcomes and Policy, University of Florida, Gainesville, FL, USA. almut@ufl.edu.; Center for Drug Evaluation and Safety, University of Florida, Gainesville, FL, USA. almut@ufl.edu.; Department of Epidemiology, University of Florida, Gainesville, FL, USA. almut@ufl.edu.<br /><searchLink fieldCode="AU" term="%22Ewig+CLY%22">Ewig CLY</searchLink>; Department of Pharmaceutical Outcomes and Policy, University of Florida, Gainesville, FL, USA.<br /><searchLink fieldCode="AU" term="%22Wang+Y%22">Wang Y</searchLink>; Department of Pharmaceutical Outcomes and Policy, University of Florida, Gainesville, FL, USA.; Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL, USA.<br /><searchLink fieldCode="AU" term="%22Smolinski+NE%22">Smolinski NE</searchLink>; Department of Pharmaceutical Outcomes and Policy, University of Florida, Gainesville, FL, USA.<br /><searchLink fieldCode="AU" term="%22Toyserkani+GA%22">Toyserkani GA</searchLink>; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22LaCivita+C%22">LaCivita C</searchLink>; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Lackey+L%22">Lackey L</searchLink>; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Eggers+S%22">Eggers S</searchLink>; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Zhou+EH%22">Zhou EH</searchLink>; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Diaby+V%22">Diaby V</searchLink>; Health Economics and Value Evidence Partnership, Otsuka Pharmaceutical Development Corporation Inc, Princeton, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Sarayani+A%22">Sarayani A</searchLink>; Janssen Research and Development, Johnson & Johnson, Brisbane, CA, USA.<br /><searchLink fieldCode="AU" term="%22Thai+T%22">Thai T</searchLink>; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Maro+JC%22">Maro JC</searchLink>; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Rasmussen+SA%22">Rasmussen SA</searchLink>; Department of Genetic Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.
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              Text: 2025 Feb
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