急性缺血性脑卒中治疗药物临床试验技术指导原则(国家食药监管总局通告2018年第28号) ...

2023-6-5 18:45| 发布者: 葆伢美| 查看: 691| 评论: 0|来自: 国家药监局

摘要: 本则主要适用于急性缺血性脑卒中(急性脑梗死)。旨在为治疗急性脑卒中的化学药物和治疗用生物制品临床试验的设计、实施和评价提供方法学指导,以期通过规范的临床试验,评价药物的有效性和安全性,为临床治疗的选择 ...


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七、参考文献

1.Recommendations for Standards Regarding Preclinical Neuroprotective and Restorative Drug Development. Stroke,1999;30:2752-2758

2.Recommendations for Clinical Trial Evaluation of Acute Stroke Therapies. Marc Fisher. Stroke,2001;32:1598-1606

3.Recommendations for Advancing Development of Acute Stroke Therapies:Stroke Therapy Academic Industry Roundtable 3. Marc Fisher,Stroke. 2003;34:1539-1546

4.Enhancing the Development and Approval of Acute Stroke Therapies:Stroke Therapy Academic Industry Roundtable. Marc Fisher,Stroke. 2005;36:1808-1813

5.Recommendations From the STAIR V Meeting on Acute Stroke Trials,Technology and Outcomes. Marc Fisher,Stroke. 2007;38:245-248

6.Stroke Therapy Academic Industry Roundtable (STAIR) Recommendations for Extended Window Acute Stroke Therapy Trials. Jeffrey L. Saver,Stroke. 2009;40:2594-2600

7.Stroke Treatment Academic Industry Roundtable (STAIR) Recommendations for Maximizing the Use of Intravenous Thrombolytics and Expanding Treatment Options With Intra-arterial and Neuroprotective Therapies. Gregory W. Albers, Stroke. 2011;42:2645-2650

8.Points to consider on clinical investigation of medicinal products for the treatment of acute stroke Stroke. CPMP/EWP/560/98,20 september 2001

9.Statistical Principles for Clinical Trials(ICH E9),

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002928.pdf

10.Choice of Control Group and Related Issues in Clinical Trials(ICH E10), http://www.ema.europa.eu/docs/en_GB/document_

library/Scientific_guideline/2009/09/WC500002925.pdf

11.《中药新药治疗中风临床研究技术指导原则》,

http://www.sfda.gov.cn/WS01/CL1616/134584.html

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