With more than 6,800 FDA-approved drugs, many of which contain psychoactive or sedative pharmaceutical ingredients which could alter the ability to operate a motor vehicle, it is crucial to put in place a systematic effort to identify the drugs that increase the risk of motor vehicle accidents. This is a critical component in assessing drug risk and designing strategies to reduce this risk.

Click here to download a readable, PDF version of Issue 1: https://www.altasciences.com/sites/default/files/2022-03/The-Altascientist_issue1_driving_2022.pdf

CHAPTERS:

- 0:07 — Section 1: The FDA Finalizes Drug-Impaired Driving Guidance

- 2:39 — Section 2: Driving Simulation Testing and CNS Side Effect Specificity

- 5:26 — Section 3: Cognitive Studies with State-of-the-Art Driving Simulator

- 7:08 — Section 4: Case Study — Clinical Study Planning Challenges of Driving Studies

- 10:12 — Section 5: A Second Case Study — Driving Assessment of Filbanserin (Addyi)

- 12:42 — Section 6: Regulatory Recommendations and Requirements

About Altasciences:

Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.