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N-Nitrosamine drug substance related impurities (NDSRIs) - A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da.
Bercu J, Dirat O, Dobo K, Jolly R, Kenyon M, Harvey J, Nudelman R, Smith G, Trejo-Martin A, Urquhart M. Bercu J, et al. Among authors: nudelman r. Regul Toxicol Pharmacol. 2024 Dec;154:105704. doi: 10.1016/j.yrtph.2024.105704. Epub 2024 Sep 24. Regul Toxicol Pharmacol. 2024. PMID: 39326488
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: nudelman r. Regul Toxicol Pharmacol. 2020 Feb;110:104524. doi: 10.1016/j.yrtph.2019.104524. Epub 2019 Nov 14. Regul Toxicol Pharmacol. 2020. PMID: 31734179
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes.
Ponting DJ, Czich A, Felter SP, Glowienke S, Harvey JS, Nudelman R, Schlingemann J, Simon S, Smith GF, Teasdale A, Thomas R. Ponting DJ, et al. Among authors: nudelman r. Regul Toxicol Pharmacol. 2024 Dec 9;156:105762. doi: 10.1016/j.yrtph.2024.105762. Online ahead of print. Regul Toxicol Pharmacol. 2024. PMID: 39662665 Free article. Review.
Sofosbuvir shows a protective effect against vertical transmission of Zika virus and the associated congenital syndrome in rhesus monkeys.
Gardinali NR, Marchevsky RS, Oliveira JM, Pelajo-Machado M, Kugelmeier T, Castro MP, Silva ACA, Pinto DP, Fonseca LB, Vilhena LS, Pereira HM, Lima SMB, Miranda EH, Trindade GF, Linhares JHR, Silva SA, Melgaço JG, Alves AMB, Moran J, Silva MCC, Soares-Bezerra RJ, Soriano A, Bentes GA, Bottino FO, Salvador Castro Faria SB, Nudelman RF, Lopes CAA, Perea JAS, Sarges K, Andrade MCR, Motta MCVA, Freire MS, Souza TML, Schmidt-Chanasit J, Pinto MA. Gardinali NR, et al. Among authors: nudelman rf. Antiviral Res. 2020 Oct;182:104859. doi: 10.1016/j.antiviral.2020.104859. Epub 2020 Jul 7. Antiviral Res. 2020. PMID: 32649965
Everolimus-eluting stents stabilize plaque inflammation in vivo: assessment by intravascular fluorescence molecular imaging.
Calfon Press MA, Mallas G, Rosenthal A, Hara T, Mauskapf A, Nudelman RN, Sheehy A, Polyakov IV, Kolodgie F, Virmani R, Guerrero JL, Ntziachristos V, Jaffer FA. Calfon Press MA, et al. Among authors: nudelman rn. Eur Heart J Cardiovasc Imaging. 2017 May 1;18(5):510-518. doi: 10.1093/ehjci/jew228. Eur Heart J Cardiovasc Imaging. 2017. PMID: 28039209 Free PMC article.
36 results