SRPC/INHAND GESC Survey: Evaluation Practices and Regulatory Considerations in 2-Year Rodent Bioassays
The International Harmonization of Nomenclature and Diagnostic Criteria—Global Editorial & Steering Committee (INHAND-GESC), through the auspices of the Scientific & Regulatory Policy Committee (SRPC), is conducting this survey to gather information from pathologists involved in the evaluation of 2-year rodent bioassays for pharmaceutical or chemical registration. The survey aims to understand current practices in histopathology evaluation, peer review, immunohistochemistry (IHC), molecular characterization, and regulatory submission preparation, as well as the impact of these analyses on nonclinical study interpretation and human health risk assessment.
Your responses will help us better understand the scope and frequency of these activities over the past decade (2016–2026), identify trends in molecular and immunohistochemical approaches for hematolymphoid tumors, and provide insights into how such data influence regulatory submissions and human risk assessment decisions.
Your responses are truly appreciated. Please complete the survey by June 1.
The survey will be comprised of the following parts:
1. Demographics/Work Experience
2. Characterization of lymphoid tumors
If you have any questions or concerns about this survey, please contact the GESC Chair, Emily Meseck.