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Genotoxicity testing regulatory

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]

A rationale for determination, testing and control of genotoxic impurities. Regulatory Toxicology and Pharmacology, 44, 198-211. [Pg.268]

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]

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See also in sourсe #XX -- [ Pg.264 ]



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GENOTOXIC

Genotoxicity tests

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