GUIDANCE ON GENOTOXICITY TESTING AND DATA INTERPRETATION FOR PHARMACEUTICALS INTENDED FO RHUMAN USE

With the ultimate goal of improving risk characterization for carcinogenic effects that have their basis in changes in the genetic material .Mechanistic information that contributes to a weight of evidence for a lack of relevant genotoxicity is often generated in vitro , for example evidence that a test compound that induces chromosome aberrations .Or by the single cell gel electrophoresis or Comet assay in which cells embedded in a thin layer of gel on a microscope slides are subjected to electric current , causing shorter pieces of DNA to migrate o.