Quantitative Interpretation of Genetic Toxicity Dose Response Data for Risk Assessment and Regulatory Decision-Making: Current Status, Persistent Challenges, and Emerging Priorities

The workshop will provide:

1. A brief overview of the state of the science regarding quantitative interpretation of genetic toxicity dose-response data, including a brief overview of the BMD combined covariate approach for potency ranking and MOA investigation,
2. A summary of recent genotoxicity risk assessment case studies, particularly those related the pharmaceutical impurities such as NDMA,
3. An in-depth overview of issues pertaining to developing consensus CES values for genotoxicity endpoints,
4. An in-depth overview of issues pertaining to the determination of effective AF values for routine interpretation of genotoxicity dose-response data for establishment of HBGVs, and
5. A brief overview of issues pertaining to interpretation of in vitro genotoxicity dose-response data in a risk context.

The workshop will include two one-hour time slots for structured discussion aimed at delineating action items and next steps.

Workshop registration is free to HESI GTTC members. Learn more and register here: https://www.emgs-us.org/p/cm/ld/fid=544