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26 results

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Page 1
Using default methodologies to derive an acceptable daily exposure (ADE).
Faria EC, Bercu JP, Dolan DG, Morinello EJ, Pecquet AM, Seaman C, Sehner C, Weideman PA. Faria EC, et al. Among authors: bercu jp. Regul Toxicol Pharmacol. 2016 Aug;79 Suppl 1:S28-38. doi: 10.1016/j.yrtph.2016.05.026. Epub 2016 May 24. Regul Toxicol Pharmacol. 2016. PMID: 27233926 Review.
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs).
Bercu JP, Masuda-Herrera M, Trejo-Martin A, Sura P, Jolly R, Kenyon M, Thomas R, Ponting DJ, Snodin D, Tuschl G, Simon S, De Vlieger K, Hutchinson R, Czich A, Glowienke S, Reddy MV, Johanssen S, Vock E, Claude N, Weaver RJ. Bercu JP, et al. Regul Toxicol Pharmacol. 2023 Aug;142:105415. doi: 10.1016/j.yrtph.2023.105415. Epub 2023 May 29. Regul Toxicol Pharmacol. 2023. PMID: 37257751 Free article.
A proposed framework for assessing risk from less-than-lifetime exposures to carcinogens.
Felter SP, Conolly RB, Bercu JP, Bolger PM, Boobis AR, Bos PM, Carthew P, Doerrer NG, Goodman JI, Harrouk WA, Kirkland DJ, Lau SS, Llewellyn GC, Preston RJ, Schoeny R, Schnatter AR, Tritscher A, van Velsen F, Williams GM. Felter SP, et al. Among authors: bercu jp. Crit Rev Toxicol. 2011 Jul;41(6):507-44. doi: 10.3109/10408444.2011.552063. Epub 2011 May 18. Crit Rev Toxicol. 2011. PMID: 21591905 Review.
Use of the bacterial reverse mutation assay to predict carcinogenicity of N-nitrosamines.
Trejo-Martin A, Bercu JP, Thresher A, Tennant RE, Thomas RF, Cross K, Czich A, Waese K, Nicolette JJ, Murray J, Sonders P, Kondratiuk A, Cheung JR, Thomas D, Lynch A, Harvey J, Glowienke S, Custer L, Escobar PA. Trejo-Martin A, et al. Among authors: bercu jp. Regul Toxicol Pharmacol. 2022 Nov;135:105247. doi: 10.1016/j.yrtph.2022.105247. Epub 2022 Aug 23. Regul Toxicol Pharmacol. 2022. PMID: 35998738 Free article.
Qualification of impurities based on metabolite data.
Weidolf L, Andersson T, Bercu JP, Brink A, Glowienke S, Harvey J, Hayes MA, Jacques P, Lu C, Manevski N, Muster W, Nudelman R, Ogilvie R, Ottosson J, Teasdale A, Trela B. Weidolf L, et al. Among authors: bercu jp. Regul Toxicol Pharmacol. 2020 Feb;110:104524. doi: 10.1016/j.yrtph.2019.104524. Epub 2019 Nov 14. Regul Toxicol Pharmacol. 2020. PMID: 31734179
A harmonization effort for acceptable daily exposure application to pharmaceutical manufacturing - Operational considerations.
Hayes EP, Jolly RA, Faria EC, Barle EL, Bercu JP, Molnar LR, Naumann BD, Olson MJ, Pecquet AM, Sandhu R, Shipp BK, Sussman RG, Weideman PA. Hayes EP, et al. Among authors: bercu jp. Regul Toxicol Pharmacol. 2016 Aug;79 Suppl 1:S39-47. doi: 10.1016/j.yrtph.2016.06.001. Epub 2016 Jun 3. Regul Toxicol Pharmacol. 2016. PMID: 27267172 Review.
In Silico Assessment of Biomolecule Reactivity with Leachables.
Johnson C, Kiehl D, Christiaens P, Jodar FS, Cuyvers R, Bassan A, Beilke L, Bercu JP, Costelloe T, Cross KP, Feilden A, Filler R, Lucas MF, Masuda-Herrera MJ, Moghimi M, Morley N, Paskiet D, Pavan M, Pletz J, Reddy MV, Waine CJ, Myatt GJ. Johnson C, et al. Among authors: bercu jp. PDA J Pharm Sci Technol. 2024 Jun 28;78(3):214-236. doi: 10.5731/pdajpst.2022.012818. PDA J Pharm Sci Technol. 2024. PMID: 38942477
26 results