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ICH S1 prospective evaluation study: weight of evidence approach to predict outcome and value of 2-year rat carcinogenicity studies. A report from the regulatory authorities subgroup.
Bourcier T, McGovern T, Cavaliero T, Ebere G, Nishikawa A, Nishimura J, Ogawa K, Pasanen M, Vespa A, Van der Laan JW. Bourcier T, et al. Among authors: mcgovern t. Front Toxicol. 2024 Apr 11;6:1353783. doi: 10.3389/ftox.2024.1353783. eCollection 2024. Front Toxicol. 2024. PMID: 38665214 Free PMC article.
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, Ferreira AS, van Aerts L, Vespa A, Whomsley R. Kruhlak NL, et al. Among authors: mcgovern tj. Regul Toxicol Pharmacol. 2024 May 14:105640. doi: 10.1016/j.yrtph.2024.105640. Online ahead of print. Regul Toxicol Pharmacol. 2024. PMID: 38754805 Free article.
Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays.
Li X, Le Y, Seo JE, Guo X, Li Y, Chen S, Mittelstaedt RA, Moore N, Guerrero S, Sims A, King ST, Atrakchi AH, McGovern TJ, Davis-Bruno KL, Keire DA, Elespuru RK, Heflich RH, Mei N. Li X, et al. Among authors: mcgovern tj. Regul Toxicol Pharmacol. 2023 Jun;141:105410. doi: 10.1016/j.yrtph.2023.105410. Epub 2023 May 18. Regul Toxicol Pharmacol. 2023. PMID: 37210026
236 results