Abuse liability assessments: Drug discrimination
Evaluate your abuse liability testing requirements.
Prescription drug abuse is a worldwide health concern. Any compound that enters the brain and affects the central nervous system (CNS), regardless of the therapeutic indication, must undergo abuse liability testing, but the process is complex.
If you are developing a new molecular entity (NME) that needs preclinical and human abuse liability (HAL) studies, you need to add several steps to your development plans. Apply our experience as we work with you to evaluate your NME’s mechanism of action, pharmacokinetics and active metabolites, delivering a comprehensive proposal based on your drug.
Early discussions to enable success.
When it comes to abuse liability testing, a proactive plan is the best strategy to keep your timeline–and expectations–on track.
An early understanding of the “flags” from early development work is valuable as it informs preclinical and clinical abuse liability studies, which may be required downstream. We help you gain critical awareness of potential abuse risks as early as possible to ensure that your clinical phases and licensing proceed as planned.