This paper describes the use of data about the eects of medicinal drugs on driving that are submitted by applicants for product licensing in the European Union. Existing European guidelines and directives are discussed in order to illustrate the need to review the requirements of data pertaining to
Driving, drug research and the pharmaceutical industry
โ Scribed by A. Patat
- Publisher
- John Wiley and Sons
- Year
- 1998
- Tongue
- English
- Weight
- 139 KB
- Volume
- 13
- Category
- Article
- ISSN
- 0885-6222
No coin nor oath required. For personal study only.
โฆ Synopsis
It is known that psychoactive drugs may produce impairment of attention and skills involved in driving performance and thus may increase the risk of trac accident involvement. Several reliable and sensitive methods are available to assess dierent aspects of driving performance in safe conditions. They include various laboratory tests which explore psychomotor performance and cognitive functions (selective and divided attention, speed of reaction, sustained attention), electrophysiological measures (spectral analysis of resting EEG, multiple sleep latency test, saccadic eye movement) and other more complex measures such as driving simulators and on-the-road actual driving tests. Various combinations of these techniques should be used to demonstrate potential drug-induced changes in driving or skills related to driving in standardized placebo-controlled studies with healthy volunteers and/or patients. In my opinion, in addition to ecacy, behavioural toxicity should be assessed during drug development in order to obtain a reliable evaluation of the beneยฎt/risk ratio for the patients and should be included in the registration ยฎle of all new psychoactive drugs.
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