Preventing Late Stage Failure due to Genotoxic Liabilities by ProQuest


Two options for genotoxicity screening have been proposed for revising the current guidelines. The first option is to retain the in vitro mammalian tests in the battery but change the test protocol. The top concentration of compound tested will be reduced from 10 mM to 1 mM, as will the level of cytotoxicity at which the tests are performed. There will no longer be a need to test into the precipitating range for insoluble compounds.

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