Modeling Cancer Data with EPA's Benchmark Dose Software

Presentation to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) panel on nitrosamines in pharmaceuticals on the use of EPA cancer modeling methodologies and Benchmark Dose Software (BMDS).  Information will be provided on how EPA's technical guidelines are used for cancer data, including situations where multiple, independent tumors are observed or increase mortality is observed in exposed animals.

Impact/Purpose

Training will provide federal, international, and industry participants with information on how EPA applies its dose-response technical guidance when modeling cancer data (including multitumor and time-to-tumor analyses) and provide worked examples on nitrosamine cancer datasets.

Citation

Davis, Allen. Modeling Cancer Data with EPA's Benchmark Dose Software. BMD Training (Carcinogenicity Data) ICH M& EWG Nitrosamine SubGroup, Nashville, TN, October 01, 2025.