摘要
药驾(即在药物影响下驾驶)可诱发交通事故,是重要的公共健康问题。美国食品药品管理局(FDA)为促进相关研究,于2015年1月发布了《供企业用评价药物影响驾驶机动车能力指导原则(草案)》,详细阐述了精神活性药物损害驾驶能力研究的一般要求。介绍该指导原则的主要内容:评估驾驶损害的需要、评价药物对驾驶影响的分层方法以及相关药品说明书的撰写,期望对我国相关规范的制订、研究工作的开展以及药品说明书的撰写有所帮助。
Drug driving （driving under the inference of drugs） can induce motor vehicle accidents （MVAs） and is a major public health problem. FDA issued the draft ＂Evaluating Drug Effects on the Ability to Operate a Motor Vehicle Guidance for Industry＂ in January, 2015 to promote the research in this area. The general principles of research on driving ability damaged by psychoactive drug are elaborated. The main contents of the guidance are introduced here, including the need to evaluate driving impairment, the tiered approach to evaluate drug effects on driving as well as the drugs＇ labeling. It is expected to be helpful to create corresponding guidance, do such research, and write its labeling in our country.
出处
《药物评价研究》
CAS
2015年第4期363-367,共5页
Drug Evaluation Research
