Rodent home cage monitoring for preclinical safety pharmacology assessment: results of a multi-company validation evaluating nonclinical and clinical data from three compounds.

ABSTRACT:

Introduction

The presence of central nervous system (CNS) safety concerns during early clinical testing that were not picked up in standard preclinical assessment is a major cause of attrition in drug development. It is also very expensive, time consuming and potentially dangerous for clinical trial participants. Rodent home cage monitoring approaches have previously been shown to deliver significant animal welfare benefits through group/social housing, minimal interventions avoiding stress that can confound results, and in some cases also animal reduction benefits with the multiplex data acquisition requiring fewer total animals. Here we looked at the utility of home cage monitoring to uncover potential CNS effects not identified using standard safety pharmacology tests.

Method

SUBMITTER: Sillito RR 

PROVIDER: S-EPMC12626872 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature