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Teratogenic Risk Impact Mitigation (TRIM): Development of Explicit Criteria to Facilitate Decisions Regarding Teratogenic Risk Mitigation Strategies.

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Title: Teratogenic Risk Impact Mitigation (TRIM): Development of Explicit Criteria to Facilitate Decisions Regarding Teratogenic Risk Mitigation Strategies.
Authors: Ewig CLY; Department of Pharmaceutical Outcomes and Policy, University of Florida, College of Pharmacy, Malachowsky Hall, 1889 Museum Road, Suite 6300, Gainesville, FL, 32611, USA., Wang Y; Department of Pharmaceutical Outcomes and Policy, University of Florida, College of Pharmacy, Malachowsky Hall, 1889 Museum Road, Suite 6300, Gainesville, FL, 32611, USA.; Center for Drug Evaluation and Safety, University of Florida, Gainesville, FL, USA., Smolinski NE; Department of Pharmaceutical Outcomes and Policy, University of Florida, College of Pharmacy, Malachowsky Hall, 1889 Museum Road, Suite 6300, Gainesville, FL, 32611, USA.; Center for Drug Evaluation and Safety, University of Florida, Gainesville, FL, USA., Toyserkani GA; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., LaCivita C; Independent, Potomac, 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., Sahin L; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Abu-Rustum RS; Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville, FL, USA., Bateman BT; Stanford University School of Medicine, Palo Alto, CA, USA., Berard A; Faculty of Pharmacy, University of Montreal; and CHU Sainte-Justine, Montreal, Canada., Chambers CD; University of California, San Diego, CA, USA., Choby B; Independent, Memphis, TN, USA., Conover EA; University of Nebraska Medical Center, Omaha, NE, USA., Greene MF; Department of Obstetrics and Gynecology, Harvard Medical School, Boston, MA, USA., Hernández-Díaz S; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA., Jamieson DJ; University of Iowa Health Care, Iowa City, IA, USA., Običan SG; Department of Obstetrics and Gynecology, University of South Florida, Tampa, FL, USA., Polifka JE; University of Washington, Seattle, WA, USA., Roussos-Ross K; Departments of OBGYN, Psychiatry, University of Florida, Gainesville, FL, USA., Sheffield JS; Johns Hopkins Medicine, Baltimore, MD, USA., Lavigne SV; UConn Health, Farmington, CT, USA., Zimmermann EM; Division of Gastroenterology, Hepatology and Nutrition, University of Florida, Gainesville, FL, USA., Laffan SB; Amgen R&D, Translational Safety and Bioanalytical Sciences, Thousand Oaks, CA, USA., DeLise AM; Novartis Pharmaceutical Company, East Hanover, NJ, USA., Gilsenan AW; RTI Health Solutions, Research Triangle Park, NC, USA., Hammad TA; Takeda Development Center Americas, Inc., Cambridge, MA, USA., Hampp C; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Hardy JR; Independent, Greater Montreal, Quebec, Canada., Knox CA; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Shields K; Independent, Philadelphia, PA, USA., Smith MY; Evidera, Inc., New London, NH, USA.; University of Southern California Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, Los Angeles, CA, USA., Sobel RE; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Tassinari MS; Independent, Harwich Port, 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 University School of Medicine, Baltimore, MD, USA., Winterstein AG; Department of Pharmaceutical Outcomes and Policy, University of Florida, College of Pharmacy, Malachowsky Hall, 1889 Museum Road, Suite 6300, Gainesville, FL, 32611, 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.
Source: Drug safety [Drug Saf] 2025 Dec; Vol. 48 (12), pp. 1387-1397. Date of Electronic Publication: 2025 Aug 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
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