Geno toxicity assays(5 marks only)
Gene-Tox Assays:
- Assays meet ICH S2(R1) recommendations
- Assays require a small amount of compound
- Rapid turnaround time (10 business days)
- Detect both frameshifts and base-pair substitutions
- The Ames fluctuation test utilizes 4 Salmonella typhimurium tester strains (TA98, TA100, TA1535 and TA1537)
- Testing can be performed with and without metabolic activation by rat liver S9 fraction
- Confirm the negative Ames test results
- Bacterial cytotoxicity assays are conducted concurrently with Ames test
- Objective and consistent data
- The in vitro micronucleus assay uses automated scoring by High Content Analysis (HCA) versus manual scoring.

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