Lizarraga LE, Patlewicz G , Dean JL II, Zhao QJ, Kaiser JP. 2021. Provisional peer-reviewed toxicity values for 3,4-toluenediamine (CASRN 496-72-0). Cincinnati (OH): U.S. Environmental Protection Agency; 2021 Aug. PMID: 36191119.
Publication: Report
/ Topics: chemical safety assessment
Tate T, Wambaugh J, Patlewicz G , Shah I. 2021. Repeat-dose toxicity prediction with Generalized Read-Across (GenRA) using targeted transcriptomic data: A proof-of-concept case study. Comput Toxicol 19(Aug):100171; doi: 10.1016/j.comtox.2021.100171 . PMID: 37309449.
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Publication: Manuscripts
/ Topics: transcriptomics
Doepker CD , Heintz MM , van de Ligt JLG, Wikoff DS . 2021. Review of potential risks associated with supplementary dietary exposure to nitrate-containing compounds in swine — A paradox in light of emerging benefits. Trans Anim Sci 5(4):txab203; doi: 10.1093/tas/txab203 . PMID: 34909600.
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Publication: Manuscripts
/ Topics: Food science , nutrition
Wikoff D , Fitch S , Borghoff S . Case-study applications using evidence-based approaches to assess endocrine activity for risk assessment. Invited speaker (Wikoff): 61st Annual Meeting of the Society for Birth Defects Research & Prevention, Virtual, June 2021.
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Publication: Abstracts and Presentations
/ Topics: risk assessment
Parker JA, Boles C, Buerger AN , Fung ES, Maier A. 2021. Derivation of an occupational exposure limit for β-glucans. Regul Toxicol Pharmacol 123(July):104959; doi: 10.1016/j.yrtph.2021.104959 . PMID: 34019963.
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Publication: Manuscripts
/ Topics: Occupational , Occupational exposure limits (OELs)
Revollo JR, McKinzie PB, Robison TW , Dobrovolsky VN. 2021. Mutational signatures in T-lymphocytes of rats treated with N-propyl-N-nitrosourea and procarbazine. Environ Mol Mutagen 62(6):350-363; doi: 10.1002/em.22448 . PMID: 34117657.
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Publication: Manuscripts
/ Topics: Cancer , flow cytometry , pharmacology
Werner JA, Davies R, Wahlstrom J, Dahal UP, Jiang M, Stauber J, David B, Siska W…, Monticello TM . 2021. Mercapturate pathway metabolites of sotorasib, a covalent inhibitor of KRASG12C, are associated with renal toxicity in the Sprague Dawley rat. Toxicol Appl Pharmacol 423(July 15):11578; doi: 10.1016/taap.2021.115578 . PMID: 34004237.
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Publication: Manuscripts
/ Topics: metabolites , nonclinical safety assessment
Ishida K, Werner J, Lafleur N, Wisler J, Wannberg S, Kalanzi J, Bussiere J, Monticello TM . 2021. Phosphatidylinositol 3-kinase δ-specific inhibitor-induced changes in the ovary and testis in the Sprague Dawley rat and cynomolgus monkey. Int J Toxicol 40(4):344-354; doi: 10.1177/109158211008175 . PMID: 33866838.
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Publication: Manuscripts
/ Topics: pharmacology
Wikoff D . The [acceptable daily intake] for low- and no-calorie sweeteners: Origin, interpretation, and application. Invited speaker: Continuing education webinar, Institute for the Advancement of Food and Nutrition Sciences, July 2021.
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Publication: Abstracts and Presentations
/ Topics: food safety , Food science
Mayne TJ, Nordyke RJ , Schold JD, Weir MR, Mohan S. 2021. Defining a minimal clinically meaningful difference in 12-month estimated glomerular filtration rate for clinical trials in deceased donor kidney transplantation. Clin Transplant 35(7):e14326; doi: 10.1111/ctr.14326 . PMID: 33896052.
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Publication: Manuscripts
/ Topics: Epidemiology
Haddadin Z, Rankin DA, Lipworth L, Suh M , McHenry R, Blozinski A, Salib George S, Fernandez KN, et al. 2021. Respiratory virus surveillance in infants across different clinical settings. J Pediat 234(July):p164-p171; doi: 10.1016/j.jpeds.2021.03.036 . PMID: 33774057.
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Publication: Manuscripts
/ Topics: Epidemiology
Fitch SE , Payne LE, van de Ligt JLG, Doepker C , Handu D, Cohen SM, Anyangwe N, Wikoff D . 2021. Use of acceptable daily intake (ADI) as a health-based benchmark in nutrition research studies that consider the safety of low-calorie sweeteners (LCS): A systematic map. BMC Pub Health 21(1):956; doi: 10.1186/s12889-021-10934-2 . PMID: 34016063.
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Publication: Manuscripts
/ Topics: nutrition , Systematic Review
Borghoff SJ , Fitch SE , Black MVB, McMullen PD, Andersen ME, Chappell GA. 2021. A systematic approach to evaluate plausible modes of [action] for mouse lung tumors in mice exposed to 4-methylimidozole. Regul Toxicol Pharmacol 124(Aug):104977; doi: 10.1016/j.yrtph.2021.104977 . PMID: 34174380.
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Publication: Manuscripts
/ Topics: mode of action
Pittman CA, Roura R, Price C , Lin FR, Marrone N, Nieman CL. 2021. Racial/ethnic and sex representation in US-based clinical trials of hearing loss management in adults: A systematic review. JAMA Otolaryngol Head Neck Surg 147(7):656–662; doi: 10.1001/jamaoto.2021.0550 . PMID: 33885733.
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Publication: Manuscripts
/ Topics: hearing loss , Systematic Review
Yi JS, Pittman CA, Price CL , Nieman CL, Oh ES. 2021. Telemedicine and dementia care: A systematic review of barriers and facilitators. J Am Med Direct Assoc; 22(7):P1396-P1402; doi: 10.1016/j.jamda.2021.03.015 . PMID: 33887231.
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Publication: Manuscripts
/ Topics: Systematic Review
Wallace E, Sacks NC , Cyr P , Baker-Wagner M. An observational cohort analysis on the economic impact of chronic kidney disease in patients with fabry disease. Poster presentation, ISPOR Annual International Meeting, Virtual, May 2021.
Publication: Abstracts and Presentations
/ Topics: Health Economics and Outcomes Research (HEOR)
Yin W, Nie Z, Dingley K , Trzoss M, Krilov G, Marshall N et al. 2021. Characterization of potent paracaspase MALT1 inhibitors for hematological malignancies. Blood 138 (Sup 1):1187; doi: 10.1182/blood-2021-153159 .
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Publication: Manuscripts
/ Topics: Cancer , modeling
Rehorn MR, Sacks NM, Cyr PL , Emden, MR, Sherwood R, Pokorney SD. Rates of catheter ablation for paroxysmal supraventricular tachycardia in the United States. J Am Coll Cardiol 77 (18-Sup1):330. Poster Contribution, American College of Cardiology, 2021.
Publication: Abstracts and Presentations
/ Topics: Epidemiology
Kimzey A , Mease K , Mounho-Zamora B, Wood M. 2021. 13. Biosimilar products—A review of past and current regulatory approval standards for preclinical safety studies. In: Translational Medicine : Optimising Preclinical Safety Evaluation of Biopharmaceuticals. CRC Press: Boca Raton, FL .
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Publication: Book Chapters
/ Topics: regulatory toxicology
Jaeschke H, Murray FJ, Monnot AD, Jacobson-Kram D, Cohen SM, Hardisty JF, Atillasoy E… Wikoff D , et al. 2021. Assessment of the biochemical pathways for acetaminophen toxicity: Implications for its carcinogenic hazard potential. Regul Toxicol Pharmacol 120(March):104859; doi: 10.1016/j.yrtph.2020.104859 . PMID: 33388367.
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