In vitro genotoxicity test package of antibiotics for human use submitted to the Japanese regulatory agency during 2004–2015
Author:
Affiliation:
1. Division of Office of New Drugs, Pharmaceuticals and Medical Devices Agency
2. Present address: Department of Veterinary Pathophysiology and Animal Health, Graduate School of Agricultural and Life Sciences, The University of Tokyo
Publisher
Japanese Society of Toxicology
Link
https://www.jstage.jst.go.jp/article/fts/4/5/4_241/_pdf
Reference11 articles.
1. Ames, B.N., Gurney, E.G., Miller, J.A. and Bartsch, H. (1972): Carcinogens as Frameshift Mutagens: Metabolites and Derivatives of 2-acetylaminofluorene and other Aromatic Amine Carcinogens. Proc. Natl. Acad. Sci. USA, 69, 3128-3132.
2. Chen, T., Harrington-Brock, K. and Moore, M.M. (2002): Mutant frequency and mutational spectra in the Tk and Hprt genes of N-ethyl-N-nitrosourea-treated mouse lymphoma cellsdagger. Environ. Mol. Mutagen., 39, 296-305.
3. ICH guidance, M3(R2) (2009): Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (Revision 1).
4. ICH guidance, S2(R1) (2011): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use.
5. Johnson, G.E. (2012): Mammalian cell HPRT gene mutation assay: test methods. Methods Mol. Biol., 817, 55-67.
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