East A , Brady S, Isaacs K, Vallero D. The role of the Product Use Scheduler (PUS) in determining product use categories (PUCs) for owners and renters in the Combined Human Exposure Model (CHEM). Symposium presented at International Society of Exposure Science Annual Meeting, virtual, September 2021; doi: 10.23645/epacomptox.16632271 .
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Publication: Abstracts and Presentations
/ Topics: Exposure Assessment
Fisher H, East A , Vallero D. Estimating longitudinal aggregate exposure — The third module of CHEM: Source to dose. Symposium presented at International Society of Exposure Science Annual Meeting, virtual conference, September 2021; doi: 10.23645/epacomptox.16630675 .
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Publication: Abstracts and Presentations
/ Topics: consumer products , Exposure Assessment
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 (virtual) of the Society for Birth Defects Research & Prevention, 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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Publication: Manuscripts
/ Topics: carcinogens , pharmacology
Wang Y, Mittelstaedt RA, Wynne R, Chen Y, Cao X, Muskhelishvili L, Davis K, Robison TW , et al. 2021. Genetic toxicity testing using human in vitro organotypic airway cultures: Assessing DNA damage with the CometChip and mutagenesis by duplex sequencing. Environ Mol Mutagen 62(5):306-318; doi: 10.1002/em22444 . PMID: 34050964.
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