Abuse liability solutions
Test your compound for abuse liability potential with the help of an experienced partner who offers comprehensive nonclinical solutions.
Drug abuse liability assessment: Early evaluation for regulatory success
Drug abuse liability assessment is a critical component of nonclinical drug development for compounds (or metabolites) that have CNS activity, evaluating the potential for misuse, dependence, and reinforcing properties. Beyond regulatory expectations, these findings directly influence clinical trial design/requirements, labeling, scheduling, and patient safety, making early and integrated assessment essential.
Assessing abuse potential presents several challenges across therapeutic areas. Compounds with CNS activity may produce unexpected reinforcing or dependence-related effects with risk influenced by pharmacology, exposure, formulation, and route of administration.
An abuse liability assessment is typically conducted late Phase II/Phase III; however, discussions/planning should start early in the development program.