With the finalization of the FDA guidance in 2017, driving simulation studies are now required for any drug that may affect cognition. Driving simulation studies are the ideal way to collect data required for the drug label when pre- and early clinical studies show that a drug may cause somnolence or impair cognition. Our experts can design and conduct driving simulation studies to efficiently determine the extent and duration of driving ability impairment.
At Altasciences, we design driving studies to achieve your objectives, leveraging extensive experience across clinical testing of cognitive effects. We partner with Cognitive Research Corporation to use their proprietary driving simulators, nine of which are permanently installed in our clinic. We have performed over 13,000 simulated drives to date, analyzing the impairment seen at peak exposure and/or the effect seen the morning after evening dosing.
We have a suite of ten simulators on site at our clinical facilities, with space for more than 20 additional, as needed. Professional oversight is provided by fully-certified, in-house driving simulation study specialists.
Consult our general Driving Simulation Fact Sheet
Contributed to the market approval of Addyi (flibanserin), a novel, non-hormonal, multifunctional serotonin agonist antagonist (MSAA) for the treatment of hypoactive sexual desire disorder in premenopausal women.
Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide comprehensive support research services and bioanalytical expertise.