抗肿瘤药物临床试验技术指导原则

Wewillcontinuetoimprovethecompany'sinternalcontrolsystem,andsteadyimprovementinabilitytomanageandcontrol,optimizebusinessprocesses,toensuresmoothprocesses,responsibilitiesinplace;tofurtherstrengtheninternalcontrols,playacontrolpostindependentoversightroleofevaluationcomplyingwiththird-partyresponsibility;toactivelymakeuseofinternalaudittoolsdetectpotentialmanagement,streamline,standardizerelatedtransactions,strengtheningoperationsinaccordancewithlaw.Deepeningtheinformationmanagementtoensurefullcommunicationzeroresistance.ToconstantlyperfectERP,andBFS++,andPI,andMIS,andSCM,informationsystembasedconstruction,fullintegrationinformationsystem,achievedinformationresourcesshared;toexpandPortalsystemapplicationofbreadthanddepth,playinformationsystemonenterpriseofAssistantrole;toperfectdailyrunmaintenanceoperationofrecords,promoteproblemreasonsanalysisandsystemhandover;tostrengtheningBFS++,andERP,andSCM,technologyapplicationoftraining,improveemployeesapplicationinformationsystemofcapacityandlevel.Humanisticcaretoensurezero.TostrengtheningHumanitiescare,continuestofostercompanywindclear,andgasare,andheartShunofcultureatmosphere;strengtheninglovehelpedtrapped,caredifficultemployees;carriedoutstyleactivities,richemployeeslife;strengtheninghealthandlabourprotection,organizationcareerhealthmedical,controlcareeragainst;continuestoimplementationpsychologicalwarningpreventionsystem,trainingemployeeshealthofcharacter,andstableofmoodandenterprisingofattitude,createdfriendlyfraternityofHumanitiesenvironment.Tostrengthenriskmanagement,ensurethatthebusinessofzerorisk.Tostrengthenedbusinessplansmanagement,willbusinessbusinessplanscovertoalllevel,ensurethebusinesscancontrolincontrol;tocloseconcernfinancial,andcoalelectriclinkage,andenergy-savingscheduling,nationalpolicytrends,strengtheningtrack,activeshould;toimplementationState-ownedassetsmethod,furtherspecificationbusinessfinancialmanagement;toperfectrisktubecontrolsystem,achievedriskrecognition,andmeasure,andassessment,andreport,andcontrolfeedbackofclosedringmanagement,improveriskpreventioncapacity.Tofurtherstandardizetrading,andstrivetoachieveaccordingtolaw,standardizeandfair.Innovationofperformancemanagement,toensurethatpotentialemployeeszerofly.Tostrengthenperformancemanagement,processcontrol,enhanceemployeeevaluationandlevelsofeffectivecommunicationtoimproveperformancemanagement.Tofurtherquantifyandrefineemployeestandards...Work,fullplayparty,andbranch,andmembersinfivetypeEnterpriseconstructionintheofcorerole,andfightingfortressroleandpioneermodelrole;tocontinuestostrengtheningfourgoodleadershipconstruction利用设在基坑边的固定泵输送砼到施工面，人工摊铺，平板振捣器振捣密实，用刮杠沿模板顶将砼刮平，并用木抹搓平压实，确保砼密实和表面平整。砼浇注时埋设支立模板及钢筋支架所需预埋铁件playlevelscadresinenterprisedevelopmentintheofbackbonebackbonerole;tofullstrengtheningmembersyouthwork,fullplayyouthemployeesincompanydevelopmentintheofforcerole;toimproveindependentCommissionagainstcorruptionworklevel,strengtheningonenterprisebusinesskeylinkofeffectivenessmonitored.,Andmaintainstability.Tofurtherstrengthenpublicityandeducation,improvetheoveralllegalsystem.Wemuststrengthensafetymanagement,establishandimprovetheeducation,supervision,andevaluationasoneofthetrafficsafetymanagementmechanism.ToconscientiouslysumuptheOlympicsecuritycontrols,promotingintegratedmanagementtoahigherlevel,higherstandards,ahigherlevelofdevelopment.Employees,todayislunarcalendaronDecember24,theoxBellisabouttoring,atthistimeofyear,weclearlyfeelthepulseoftheXXpowergenerationcompanytoflourish,tomoreclearlyhearXXpowergenerationcompaniesmatureandsymmetrybreathing.Recallingpastoneanotheracrossarailing,weareenthusiasticandfullofconfidence.Futuredevelopmentopportunities,wemoreexcitingfightmorespirited.Employees,letustogetheracross2013fullofchallengesandopportunities,tocreateagreen,low-costoperation,fullofhumanecareofaworld-classpowergenerationcompanyandworkhard!TheoccasionoftheSpringFestival,mysincerewishthatyouandthefamiliesofthestaffinthenewyear,goodhealth,happy,happy!抗肿瘤药物临床试验技术指导原则一、概述恶性肿瘤是严重威胁人类生命的一类疾病，尽管现有治疗手段取得了一定疗效，但多数肿瘤患者生存时间有限，缺乏有效的可以治愈的药物，亟需开发新的药物来满足需要。在抗肿瘤药物的风险效益评估中，医护人员和患者可能愿意承受相对较大的安全性风险，所以抗肿瘤药物的临床研究除遵循一般药物临床研究原则外，还应考虑其特殊性。由于肿瘤生物学研究的进展，一些新的作用机制、作用靶点的抗肿瘤药物不断涌现，呈现出不同于以往传统细胞毒类药物的安全性和有效性特点；肿瘤疾病的药物治疗也从以往的单纯追求肿瘤缩小向延长患者的生存期、提高生存质量转变，这些改变使抗肿瘤药物临床疗效评价终点指标也出现较大改变。因此，传统的抗肿瘤药物开发模式已经变得不适宜，需要更多地探索能加快和促进开发进程的临床研究策略。本指导原则将对抗肿瘤药物临床研究一般考虑进行阐述，重点阐述在不同临床研究阶段中需要重点考虑的问题，旨在为抗肿瘤药物临床研究的设计、实施和评价提供方法学指导。申请人在进行临床研究时，还应当参照国家食品药品监督管理局（以下简称SFDA）既往发布的相关指导原则和《药物临床试验质量管理规范》（GCP）要求进行，对于一般药物临床研究需要遵从的原则以及与其他指导原则重复内容在本文中不再赘述。本指导原则主要适用于抗肿瘤新化合物的临床研究，抗肿瘤生物制Wewillcontinuetoimprovethecompany'sinternalcontrolsystem,andsteadyimprovementinabilitytomanageandcontrol,optimizebusinessprocesses,toensuresmoothprocesses,responsibilitiesinplace;tofurtherstrengtheninternalcontrols,playacontrolpostindependentoversightroleofevaluationcomplyingwiththird-partyresponsibility;toactivelymakeuseofinternalaudittoolsdetectpotentialmanagement,streamline,standardizerelatedtransactions,strengtheningoperationsinaccordancewithlaw.Deepeningtheinformationmanageme