If your investigational product affects the central nervous system, understanding its abuse potential is more than a regulatory requirement — it helps keep patients safe. Human abuse liability studies are a key part of this process, informing labeling, drug scheduling, and approval outcomes.
In this white paper, Clinilabs outlines the full abuse potential assessment process, based on FDA guidance and our own hands-on experience supporting CNS drug development. Read it now to explore:
- What regulators look for in abuse potential assessments
- The role of preclinical, animal, and human studies
- How post-market data and labeling influence outcomes
- Why choosing a CNS CRO like Clinilabs improves accuracy, enrollment, and execution
Whether you’re in early development or planning for submission, this white paper offers the clarity you need to move forward with confidence.
