Whether you’re studying sedatives, antidepressants, or cognitive enhancers, you must evaluate your drug’s effects on driving to ensure CNS drug safety. However, these studies require the right endpoints, expertise, and execution to avoid delays and support your NDA. What do you need to know to plan and run successful driving simulation studies?
Download our white paper for all the details, including:
- FDA’s 2015 guidance and the science behind it
- On-road and simulated driving assessments: use cases and key differences
- Tips for integrating PK/PD and cognitive assessments
- Clinilabs’ experience and capabilities in global driving studies