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Journal Abstract Search

134 related items for PubMed ID: 39067806

  • 1. N-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP.
    Powley MW, Sobol Z, Johnson GE, Clark RW, Dalby SM, Ykoruk BA, Galijatovic-Idrizbegovic A, Mowery MD, Escobar PA.
    Regul Toxicol Pharmacol; 2024 Sep; 152():105681. PubMed ID: 39067806
    [Abstract] [Full Text] [Related]

  • 2. Ames test study designs for nitrosamine mutagenicity testing: qualitative and quantitative analysis of key assay parameters.
    Thomas DN, Wills JW, Tracey H, Baldwin SJ, Burman M, Williams AN, Harte DSG, Buckley RA, Lynch AM.
    Mutagenesis; 2024 Mar 12; 39(2):78-95. PubMed ID: 38112628
    [Abstract] [Full Text] [Related]

  • 3. Permitted daily exposure limits for noteworthy N-nitrosamines.
    Johnson GE, Dobo K, Gollapudi B, Harvey J, Kenny J, Kenyon M, Lynch A, Minocherhomji S, Nicolette J, Thybaud V, Wheeldon R, Zeller A.
    Environ Mol Mutagen; 2021 Jun 12; 62(5):293-305. PubMed ID: 34089278
    [Abstract] [Full Text] [Related]

  • 4. Use of the benchmark-dose (BMD) approach to derive occupational exposure limits (OELs) for genotoxic carcinogens: N-nitrosamines.
    Blum K, FitzGerald R, Wilks MF, Barle EL, Hopf NB.
    J Appl Toxicol; 2023 Aug 12; 43(8):1183-1200. PubMed ID: 36840679
    [Abstract] [Full Text] [Related]

  • 5. Comparison of the transgenic rodent mutation assay, error corrected next generation duplex sequencing, and the alkaline comet assay to detect dose-related mutations following exposure to N-nitrosodiethylamine.
    Bercu JP, Zhang S, Sobol Z, Escobar PA, Van P, Schuler M.
    Mutat Res Genet Toxicol Environ Mutagen; 2023 Oct 12; 891():503685. PubMed ID: 37770142
    [Abstract] [Full Text] [Related]

  • 6. Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA).
    Kruhlak NL, Schmidt M, Froetschl R, Graber S, Haas B, Horne I, Horne S, King ST, Koval IA, Kumaran G, Langenkamp A, McGovern TJ, Peryea T, Sanh A, Siqueira Ferreira A, van Aerts L, Vespa A, Whomsley R.
    Regul Toxicol Pharmacol; 2024 Jun 12; 150():105640. PubMed ID: 38754805
    [Abstract] [Full Text] [Related]

  • 7. Estimation of acceptable daily intake values based on modeling and in vivo mutagenicity of NDSRIs of fluoxetine, duloxetine and atomoxetine.
    Jolly RA, Cornwell PD, Noteboom J, Sayyed FB, Thapa B, Buckley LA.
    Regul Toxicol Pharmacol; 2024 Sep 12; 152():105672. PubMed ID: 38968965
    [Abstract] [Full Text] [Related]

  • 8. Genotoxicity evaluation of nitrosamine impurities using human TK6 cells transduced with cytochrome P450s.
    Li X, He X, Le Y, Guo X, Bryant MS, Atrakchi AH, McGovern TJ, Davis-Bruno KL, Keire DA, Heflich RH, Mei N.
    Arch Toxicol; 2022 Nov 12; 96(11):3077-3089. PubMed ID: 35882637
    [Abstract] [Full Text] [Related]

  • 9. Are all nitrosamines concerning? A review of mutagenicity and carcinogenicity data.
    Thresher A, Foster R, Ponting DJ, Stalford SA, Tennant RE, Thomas R.
    Regul Toxicol Pharmacol; 2020 Oct 12; 116():104749. PubMed ID: 32777431
    [Abstract] [Full Text] [Related]

  • 10. A deep dive into historical Ames study data for N-nitrosamine compounds.
    Tennant RE, Ponting DJ, Thresher A.
    Regul Toxicol Pharmacol; 2023 Sep 12; 143():105460. PubMed ID: 37495012
    [Abstract] [Full Text] [Related]

  • 11. Use of less-than-lifetime (LTL) durational limits for nitrosamines: Case study of N-Nitrosodiethylamine (NDEA).
    Bercu JP, Masuda-Herrera M, Johnson G, Czich A, Glowienke S, Kenyon M, Thomas R, Ponting DJ, White A, Cross K, Waechter F, Rodrigues MAC.
    Regul Toxicol Pharmacol; 2021 Jul 12; 123():104926. PubMed ID: 33862169
    [Abstract] [Full Text] [Related]

  • 12. Assessing the genotoxicity of N-nitrosodiethylamine with three in vivo endpoints in male Big Blue® transgenic and wild-type C57BL/6N mice.
    Zhang S, Coffing SL, Gunther WC, Homiski ML, Spellman RA, Van P, Schuler M.
    Environ Mol Mutagen; 2024 Jul 12; 65(6-7):190-202. PubMed ID: 39012003
    [Abstract] [Full Text] [Related]

  • 13. Genotoxicity assessments of N-nitrosoethylisopropylamine (NEIPA) and N-nitrosodiisopropylamine (NDIPA) in the C57BL/6J mouse.
    Ye Q, Geng X, Jiang H, Qin C, Wu H, Wang S, Wen H.
    Mutat Res Genet Toxicol Environ Mutagen; 2024 Jul 12; 896():503763. PubMed ID: 38821676
    [Abstract] [Full Text] [Related]

  • 14. Estimated Cancer Risks Associated with Nitrosamine Contamination in Commonly Used Medications.
    Li K, Ricker K, Tsai FC, Hsieh CJ, Osborne G, Sun M, Marder ME, Elmore S, Schmitz R, Sandy MS.
    Int J Environ Res Public Health; 2021 Sep 08; 18(18):. PubMed ID: 34574388
    [Abstract] [Full Text] [Related]

  • 15. Setting limits for N-nitrosamines in drugs: A defined approach based on read-across and structure-activity relationship for N-nitrosopiperazine impurities.
    Dos Santos CEM, Dorta DJ, de Oliveira DP.
    Regul Toxicol Pharmacol; 2022 Dec 08; 136():105288. PubMed ID: 36384172
    [Abstract] [Full Text] [Related]

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  • 17. Maximizing use of existing carcinogenicity data to support acceptable intake levels for mutagenic impurities in pharmaceuticals: Learnings from N-nitrosamine case studies.
    Felter SP, Ponting DJ, Mudd AM, Thomas R, Oliveira AAF.
    Regul Toxicol Pharmacol; 2023 Sep 08; 143():105459. PubMed ID: 37474097
    [Abstract] [Full Text] [Related]

  • 18. Chronic nitrosamine ingestion in 1040 rodents: the effect of the choice of nitrosamine, the species studied, and the age of starting exposure.
    Gray R, Peto R, Brantom P, Grasso P.
    Cancer Res; 1991 Dec 01; 51(23 Pt 2):6470-91. PubMed ID: 1933908
    [Abstract] [Full Text] [Related]

  • 19. Comparing BMD-derived genotoxic potency estimations across variants of the transgenic rodent gene mutation assay.
    Wills JW, Johnson GE, Battaion HL, Slob W, White PA.
    Environ Mol Mutagen; 2017 Dec 01; 58(9):632-643. PubMed ID: 28945287
    [Abstract] [Full Text] [Related]

  • 20. Presence of nitrosamine impurities in medicinal products.
    Sedlo I, Kolonić T, Tomić S.
    Arh Hig Rada Toksikol; 2021 Mar 01; 72(1):1-5. PubMed ID: 33787187
    [Abstract] [Full Text] [Related]

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