附录3---附录6 略(请首页下载全文阅读) 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 |