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抗肿瘤药物Ⅰ期临床研究设计的考虑要点作者：陈晓媛，王海学，钱思源，彭健，CHENXiao-yuan，WANGHai-xue，QIANSi-yuan，PENGJian作者单位：国家食品药品监督管理局药品审评中心,北京,100038刊名：中国临床药理学杂志英文刊名：THECHINESEJOURNALOFCLINICALPHARMACOLOGY年，卷(期)：2009,25(2)参考文献(14条)1.国家食品药品监督管理局技术评价指导原则:抗肿瘤药物临床试验技术指导原则20082.FDACenterfordrugevaluationandresearchpackageforapplication:cliniealpharmacologyandbiopharmaceutiereview20093.FaivreSSafety,pharmacokinetic,andantitumoractivivtyofSU11248,anoveloralmultitargettyrosinekinaseinhibitor,inpatientwithcancer20064.FDACenterfordrugevaluationandresearchpackageforapplication:cliniealpharmacologyandbiopharmaceuticreview20095.FDACenterfordrugevaluationandresearchpackageforapplication:clinicalpharmacologyandbiopharmaceuticreview6.FDAGuidanceforindustry,investigtor,reviewer:ExploratoryINDstudies(draft)20057.EMEACPMP/SWP/2599/02/Rev.Positionpaperonnon-clinicalsatetystudiestosurrpertclinicaltrialswithasiglemicrodose.120048.DeGeorgeJJ;AhnChang-Ho;AndrewsPARegulatoryconsiderationsforpreclinicaldevelopmentofanticancerdrugs[外文期刊]1998(3)9.FDAGuidanceforindustry:Estimatingthemaximumsafestartingdoseininitialeliniealtrialsfortherapeuticsinadulthealthyvolunteers200510.国家食品药品监督管理局技术评价指导原则:细胞毒类抗肿瘤药物非临床评价技术指导原则200611.FDAICHGuidanee.M3(R2):Nonclinicalsafetystudiesfortheconductofhumanclinicaltrialsforpharmaceuticals200812.EMEACHMP/SWP/28367/07Strategiestoidentifyandmitigaterisksforfirst-in-humanclinicaltrialswithinvestigutionalmedicinalproducts200713.ParulekarWR;EisenhauerEAPhaseItrialdesignforsolidtumorstudiesoftargeted,non-eytotoxicagents200414.CareyKDKineticanalysisofepidermalgrowthfactorreceptorsomaticmutantproteinsshowsincreasedsensitivitytotheepidermalgrowthfactorreeeptortyrosinekinaseinhibitor,edotinib[外文期刊]2006(16)本文读者也读过(3条)1.于浩.陈晓媛.柏建岭.赵杨.陈峰.夏结来.YUHao.CHENXiao-yuan.BAIJian-ling.ZHAOYang.CHENFeng.XIAJie-lai肿瘤新药Ⅱ期临床试验中的多阶段设计[期刊论文]-肿瘤2008,28(1)2.王柳春.黄纯.袁静.吴春娃.林丽.陈鹏.李凯.WANGkiuchun.HUANGChun.YUANJing.WUChunwa.LINLi.CHENPeng.LIKai卢比替康胶囊Ⅰ期临床耐受试验结果分析[期刊论文]-中国肿瘤临床2009,36(1)3.陈晓媛.钱思源.王海学.彭健.CHENXiao-yuan.QIANSi-yuan.WANGHai-xue.PENGJian抗肿瘤药物Ⅱ期临床研究设计考虑要点[期刊论文]-中国临床药理学杂志2009,25(3)本文链接：