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Genotoxicity tests for

S1 C(R1) Dose Selection for Carcinogenicity Studies of Pharmaceuticals Limit Dose S2A Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals S2B Genotoxicity A Standard Battery for Genotoxicity Testing of Pharmaceuticals Toxicokinetics and Pharmacokinetics... [Pg.60]

S2A Genotoxicity Guidance on specific aspects of regulatory genotoxicity tests for pharmaceuticals Jul 95... [Pg.77]

ICH (1996). Technical Requirements for Registration of Pharmaceuticals for Human Use. Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals. S2A document recommended for adoption at step 4 of the ICH process on July 19, 1995. Federal Register 61 18198-18202, April 24, 1996. [Pg.230]

Genotoxiciiy Studies ICH S2A Genotoxicity guidance on specific aspects of regulatory tests for pharmaceuticals ICH S2B Genotoxicity a standard battery for genotoxicity testing for pharmaceuticals Step 5 (1997) Step 5 (1997)... [Pg.554]

P.J. Duerksen-Hughes, J. Yang, and O. Ozcan, P. 53 Induction as a genotoxic test for twenty-five chemicals undergoing in vivo carcinogenicity testing. Environ. Health Perspect. 107 805, 1999. [Pg.57]

S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals... [Pg.905]

S2A Genotoxicity Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals CPMP/ICH/141/95 Step 5... [Pg.762]

F. K. Ennever, T. J. Noonan, and H. S. Rosenkranz, Mutagenesis, 2, 73 (1987). The Prediction of Animal Bioassays and Short-term Genotoxicity Tests for Carcinogenicity and Non-carcinogenicity to Humans. [Pg.212]

Genotoxicity tests for monitoring DNA damage and repair (exposure assessment)... [Pg.235]

Koppen, G. (1996) Protocol of the alkaline comet test on plant cells. Comet Newsl., 4, 2-4. Koppen, G. and Verschaeve, L. (1997) The alkaline comet test on plant cells. A new genotoxicity test for DNA strand breaks in Viciafaba. Mutat. Res., 360, 193-200. [Pg.253]

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See also in sourсe #XX -- [ Pg.48 ]



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