Guidance

Safety pharmacology

Guidance on reducing or refining animal use for safety pharmacology or toxicology studies with functional measurements (e.g. cardiovascular, central nervous system and respiratory systems).

Introduction

Safety Pharmacology studies assess the functional effects of drugs on core systems such as cardiovascular, central nervous system (CNS) and respiration, primarily in rats or dogs. View our projects with guidance for refinements and evidence for the value of CNS assessments.

Guidance for performing telemetry studies in group housed animals.

Publication: Strategies to encourage the adoption of social housing during cardiovascular telemetry recordings in non-rodents - ScienceDirect

You can read more about this project on our project page: Social-housing during rodent and non-rodent telemetry recordings.

Abuse potential studies

Highlighting opportunities to improve the predictive validity of the rat self-administration model.

Publication: The predictive validity of the rat self-administration model for abuse liability - ScienceDirect

You can read more about this project on our project page: Abuse potential studies.

Assessing the predictive value of safety pharmacology studies

Evidence for lack of predictivity between rat/mouse functional observational battery (FOB)/Irwin studies and human adverse events. Survey data for industry use and perspective for the FOB/Irwin and 3Rs opportunities.

Publication: Assessing the predictive value of the rodent neurofunctional assessment for commonly reported adverse events in phase I clinical trials - ScienceDirect

You can read more about this project on our project page: Assessing the predictive value of safety pharmacology studies.