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.
One partner to handle it all.
Your drug is unique—and so is your abuse liability testing strategy. By coordinating information gained throughout the development of your drug, both in the pre-clinical and clinical arena, we help you understand the abuse liability potential of your drug and identify gaps in the development plan.
Regulatory advice and consultancy throughout development.
With the FDA Opioids Action Plan and increasing attention on the abuse of prescription drugs, it’s crucial to understand the shifting regulatory environment.
From pre-IND to NDA review, we prepare your protocols and support their review with the FDA’s Controlled Substance Staff (CSS), help you engage with the DEA and guide your scheduling and labeling discussions. As your partner, we offer deep agency experience and leadership to ensure your program is aligned to the latest regulatory guidance, anywhere in the world.
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.
A collaborative approach with market access.
Depending on the findings from your abuse liability tests, many factors in the market may be affected. From specific labeling to record keeping and dispensing limits, you need to understand how your treatment will deal with distribution restrictions and competing drugs on the market.
Tap into our working relationship with our Market Access Consulting experts. Together, we understand and evaluate the challenges from a market perspective and reveal opportunities to maximize your product’s value.
End-to-end solutions for abuse liability testing.
Integrating the assessment of abuse potential in the drug development process is critical. A well-formed collaboration between sponsors, regulators and CRO partners like us, will help overcome challenges and guide major decision points.
We provide more than consultancy on your entire evaluation for abuse liability. Our experts will apply preclinical and clinical data generated throughout your development process to run effective, efficient studies that ensure a straightforward regulatory preparation and help advance your drug to its next milestone.