Genetic toxicology studies are conducted in a tiered approach to ensure that the toxicological relevance of earlier observations can be assessed.
Standard Genetic Toxicology Studies
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In vitro Ames test
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Chromosomal aberration
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Mouse lymphoma assays
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In vitro rodent micronucleus
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Comet Assay
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In vitro micronucleus assay
In addition, the following studies are available:
Blue Screen HC
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Detects direct acting mutagens
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Data available within 72 hours of dosing
Micro Ames
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Determines genotoxic potential
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Highly predictive of the eventual GLP study
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Results within 96 hours of dosing
Using these assays allows a number of candidate molecules to be screened simultaneously. Testing can typically be performed using 10 mg of test article.