新药研究中的非临床药物依赖性研究与评价  

Investigation and appraisal of non-clinical drug dependence in new drug development

作　　者：朱家谷[1] 宁可永[1] 刘炳林[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国药科大学学报》2008年第4期373-375,共3页Journal of China Pharmaceutical University

摘　　要：药物依赖性试验是评价一个药物可能被滥用潜力的重要手段,本文简要介绍了药物依赖性的研究与评价方法,并通过我国新药研究现状,分析了申报资料中存在的问题,介绍了当前新药申报过程中对药物依赖性研究的相关要求。Investigantion and appraisal of drug dependence is an integral link of assessing the potential of drug to be abused. This article introduced the investigation and evaluation methods involved in drug dependence in brief, and analyze the problems in the submitted data and the status quo in the new drug development. In addition, the relevant requirements for assessing drug dependence in the new drug application process were introduced.

关 键 词：新药 药物依赖性 研究与评价 

分 类 号：R969[医药卫生—药理学]