注意力缺失多动障碍(多动症,ADHD)治疗药物临床研究指导原则

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1、注意力缺失多动障碍（多动症，ADHD）治疗药物临床研究指导原则ClinicalInvestigationofMedicinalProductsfortheTreatmentofAttentionDeficitHyperactivityDisorder(ADHD)2008年12月欧洲药品管理局发布2010年3月药审中心组织翻译西安杨森制药有限公司翻译药审中心最终核准1目录概要...................................................................

2、...41.引言...................................................................41.1诊断..............................................................51.2鉴别诊断..........................................................51.3流行病学和合并病症.................................

3、...............62.范围...................................................................63.法律依据...............................................................64.患者特征和选择.........................................................74.1诊断和入选标准....................

4、................................74.2排除标准..........................................................85.疗效评价方法...........................................................85.1主要疗效终点......................................................85.2次要疗效终点...............

5、.......................................95.3其他的支持性疗效标准..............................................96.临床试验的策略和设计特点...............................................96.1在人体中的早期研究................................................96.1.1药效学........................

6、...............................96.1.2药代动力学/相互作用..........................................96.1.3剂量效应研究.................................................96.2治疗验证性研究...................................................106.2.1短期试验................................

7、....................106.2.2长期试验....................................................106.3在特殊人群中的研究...............................................116.3.1成人........................................................116.3.2学龄前儿童..................................

8、................127.临床安全性评价........................................................127.1一般建议.........................................................127.2特殊的不良事件...................................................122