Development and validation of a MedDRA-based signal detection construct for drug-induced neurobehavioral impairment
Therapeutic Advances in Drug Safety
Published online on August 03, 2026
Abstract
Therapeutic Advances in Drug Safety, Volume 17, January-December 2026.
Background:The FDA’s Guidance for an industry evaluating drug effects on the ability to operate a motor vehicle describes the need to evaluate drug-induced neurobehavioral impairment. However, the guidance does not provide instruction or the means to ...
Background:The FDA’s Guidance for an industry evaluating drug effects on the ability to operate a motor vehicle describes the need to evaluate drug-induced neurobehavioral impairment. However, the guidance does not provide instruction or the means to ...