Science Pool

Genotoxicity Risk Assessment During Lead Optimization Phase in Pharmaceutical Drug Development

  • The genotoxic potential is one of the major risks associated to potential pitfalls in drug development.
  • True positive results in the genotoxicity screening observed during the Lead Optimization phase not always represent a showstopper, but need to be carefully characterized.
  • In this scenario, the toxicologist could provide a strategy supporting the next IND enabling phase by adopting the most effective risk management to allow the highest success rate possible.
  • The process proposed can be adapted to any scenario, and provides data supporting the risk assessment ensuring the lowest attrition and the ethical use of animals.