Development and usage of virtual controls on nonclinical safety assessment studies

SOT 2025 -- In vivo studies are required for assessing nonclinical safety of products to which humans become exposed. Virtual control groups (VCGs) are one emerging strategy for the reduction of animal usage; VCGs are defined as the use of an on study representative dataset generated from historical control data to reduce or replace concurrent control animals. The purpose of this work was to determine the selection criteria required to generate a robust, consistent and representative virtual control dataset for a selected range of endpoints to support regulatory and industry movement towards the use of VCGs.