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Setting impurity limits for endogenous substances: Recommendations for a harmonized procedure and an example using fatty acids.
Jolly RA, Bandara S, Bercu J, Callis CM, Dolan DG, Graham J, HaMai D, Barle EL, Maier A, Masuda-Herrera M, Moudgal C, Parker JA, Reichard J, Sandhu R, Fung ES. Jolly RA, et al. Among authors: bandara s. Regul Toxicol Pharmacol. 2022 Oct;134:105242. doi: 10.1016/j.yrtph.2022.105242. Epub 2022 Aug 11. Regul Toxicol Pharmacol. 2022. PMID: 35964842
A critical review of the acetaminophen preclinical carcinogenicity and tumor promotion data and their implications for its carcinogenic hazard potential.
Murray FJ, Monnot AD, Jacobson-Kram D, Cohen SM, Hardisty JF, Bandara SB, Kovochich M, Deore M, Pitchaiyan SK, Gelotte CK, Lai JCK, Atillasoy E, Hermanowski-Vosatka A, Kuffner E, Unice KM, Yang K, Gebremichael Y, Howell BA, Eichenbaum G. Murray FJ, et al. Regul Toxicol Pharmacol. 2020 Dec;118:104801. doi: 10.1016/j.yrtph.2020.104801. Epub 2020 Oct 9. Regul Toxicol Pharmacol. 2020. PMID: 33039518 Free article. Review.
A hazard evaluation of the reproductive/developmental toxicity of cobalt in medical devices.
Monnot AD, Kovochich M, Bandara SB, Wilsey JT, Christian WV, Eichenbaum G, Perkins LEL, Hasgall P, Taneja M, Connor K, Sague J, Nasseri-Aghbosh B, Marcello S, Vreeke M, Katz LB, Reverdy EE, Thelen H, Unice K. Monnot AD, et al. Among authors: bandara sb. Regul Toxicol Pharmacol. 2021 Jul;123:104932. doi: 10.1016/j.yrtph.2021.104932. Epub 2021 Apr 17. Regul Toxicol Pharmacol. 2021. PMID: 33872739 Free article.
Assessment of the biochemical pathways for acetaminophen toxicity: Implications for its carcinogenic hazard potential.
Jaeschke H, Murray FJ, Monnot AD, Jacobson-Kram D, Cohen SM, Hardisty JF, Atillasoy E, Hermanowski-Vosatka A, Kuffner E, Wikoff D, Chappell GA, Bandara SB, Deore M, Pitchaiyan SK, Eichenbaum G. Jaeschke H, et al. Regul Toxicol Pharmacol. 2021 Mar;120:104859. doi: 10.1016/j.yrtph.2020.104859. Epub 2021 Jan 1. Regul Toxicol Pharmacol. 2021. PMID: 33388367 Free article. Review.
162 results