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資料３－３ ストラテラカプセル及びストラテラ内用液にて検出された新規ニトロソアミンの限度値について（企業見解）［7.8MB］ (34 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_42464.html |
| 出典情報 | 薬事審議会 医薬品等安全対策部会安全対策調査会（令和6年度第5回 8／28）《厚生労働省》 |
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R.A. Jolly et al.
Regulatory Toxicology and Pharmacology 152 (2024) 105672
Trejo-Martin, A., Bercu, J.P., Thresher, A., Tennant, R.E., Thomas, R.F., Cross, K.,
Czich, A., Waese, K., Nicolette, J.J., Murray, J., et al., 2022. Use of the bacterial
reverse mutation assay to predict carcinogenicity of N-nitrosamines. Regul. Toxicol.
Pharmacol. 135, 105247 https://doi.org/10.1016/j.yrtph.2022.105247.From.NLM.
Medline.
Valentine, CC 3rd, Young, R.R., Fielden, M.R., Kulkarni, R., Williams, L.N., Li, T.,
Minocherhomji, S., Salk, J.J., 2020. Direct quantification of in vivo mutagenesis and
carcinogenesis using duplex sequencing. Proc. Natl. Acad. Sci. U. S. A. 117 (52),
33414–33425. https://doi.org/10.1073/pnas.2013724117. Epub 2020 Dec 14.
PMID: 33318186; PMCID: PMC7776782.
Walker, M., Harvey, A.J.A., Sen, A., Dessent, C.E.H., 2013. Performance of M06, M06-2X,
and M06-HF density functionals for conformationally flexible anionic clusters: M06
functionals perform better than B3LYP for a model system with dispersion and ionic
hydrogen-bonding interactions. J. Phys. Chem. A 117, 12590–12600.
Wenzel, J., Schmidt, F., Blumrich, M., Amberg, A., Czich, A., 2022. Predicting DNAreactivity of N-nitrosamines: a quantum chemical approach. Chem. Res. Toxicol. 35
(11), 2068–2084. https://doi.org/10.1021/acs.chemrestox.2c00217. Epub 2022 Oct
27. PMID: 36302168.
White, P.A., Long, A.S., Johnson, G.E., 2020. Quantitative interpretation of genetic
toxicity dose-response data for risk assessment and regulatory decision-making:
current status and emerging priorities. Environ. Mol. Mutagen. 61 (1), 66–83.
https://doi.org/10.1002/em.22351.
Yu, G., Li, G.F., Markowitz, J.S., 2016. Atomoxetine: a review of its pharmacokinetics
and pharmacogenomics relative to drug disposition. J. Child Adolesc.
Psychopharmacol. 26 (4), 314–326. https://doi.org/10.1089/cap.2015.0137. Epub
2016 Feb 9. PMID: 26859445; PMCID: PMC4876529.
Zhao, Y., Truhlar, D.G., 2008. The M06 suite of density functionals for main group
thermochemistry, thermochemical kinetics, noncovalent interactions, excited states,
and transition elements: two new functionals and systematic testing of four M06class functionals and 12 other functionals. Theor. Chem. Acc. 120, 215–241.
12
34 / 34 ページ
Regulatory Toxicology and Pharmacology 152 (2024) 105672
Trejo-Martin, A., Bercu, J.P., Thresher, A., Tennant, R.E., Thomas, R.F., Cross, K.,
Czich, A., Waese, K., Nicolette, J.J., Murray, J., et al., 2022. Use of the bacterial
reverse mutation assay to predict carcinogenicity of N-nitrosamines. Regul. Toxicol.
Pharmacol. 135, 105247 https://doi.org/10.1016/j.yrtph.2022.105247.From.NLM.
Medline.
Valentine, CC 3rd, Young, R.R., Fielden, M.R., Kulkarni, R., Williams, L.N., Li, T.,
Minocherhomji, S., Salk, J.J., 2020. Direct quantification of in vivo mutagenesis and
carcinogenesis using duplex sequencing. Proc. Natl. Acad. Sci. U. S. A. 117 (52),
33414–33425. https://doi.org/10.1073/pnas.2013724117. Epub 2020 Dec 14.
PMID: 33318186; PMCID: PMC7776782.
Walker, M., Harvey, A.J.A., Sen, A., Dessent, C.E.H., 2013. Performance of M06, M06-2X,
and M06-HF density functionals for conformationally flexible anionic clusters: M06
functionals perform better than B3LYP for a model system with dispersion and ionic
hydrogen-bonding interactions. J. Phys. Chem. A 117, 12590–12600.
Wenzel, J., Schmidt, F., Blumrich, M., Amberg, A., Czich, A., 2022. Predicting DNAreactivity of N-nitrosamines: a quantum chemical approach. Chem. Res. Toxicol. 35
(11), 2068–2084. https://doi.org/10.1021/acs.chemrestox.2c00217. Epub 2022 Oct
27. PMID: 36302168.
White, P.A., Long, A.S., Johnson, G.E., 2020. Quantitative interpretation of genetic
toxicity dose-response data for risk assessment and regulatory decision-making:
current status and emerging priorities. Environ. Mol. Mutagen. 61 (1), 66–83.
https://doi.org/10.1002/em.22351.
Yu, G., Li, G.F., Markowitz, J.S., 2016. Atomoxetine: a review of its pharmacokinetics
and pharmacogenomics relative to drug disposition. J. Child Adolesc.
Psychopharmacol. 26 (4), 314–326. https://doi.org/10.1089/cap.2015.0137. Epub
2016 Feb 9. PMID: 26859445; PMCID: PMC4876529.
Zhao, Y., Truhlar, D.G., 2008. The M06 suite of density functionals for main group
thermochemistry, thermochemical kinetics, noncovalent interactions, excited states,
and transition elements: two new functionals and systematic testing of four M06class functionals and 12 other functionals. Theor. Chem. Acc. 120, 215–241.
12
34 / 34 ページ