Method of data interpretation for the determination of abuse liability in rodent self-administration studies under the FDA guidance document

All new molecular entities that enter the CNS and exert an activity in the brain must be assessed for abuse liability prior to a New Drug Application approval by the US Food and Drug Administration. One element of the screening process is the assessment of the reinforcing properties of the drug candidate using the regulatory-preferred species, the rat. We describe one method of data review from the standard rat IV SA study design that can be used to conclude the relative abuse liability of the new drug entity. While we do not claim the process as the only way to review or interpret the data, we believe the steps described highlight a process that the pharmaceutical development team can use as a starting point for a discussion during study protocol development.