From the FDA’s Guidance for Industry - M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
GENOTOXICITY STUDIES
An assay for gene mutation is generally considered sufficient to support all single dose clinical development trials. To support multiple dose clinical development trials, an additional assessment capable of detecting chromosomal damage in a mammalian system(s) should be completed. A complete battery of tests for genotoxicity should be completed before initiation of phase 2 trial.
From the FDA’s Guidance for Industry - M3(R2) Nonclinical Safety...
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