澳大利亚Ⅰ期临床试验介绍.pdf

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1、万方数据WidebreadthofstudiesStudycapabilitiesProofofconcept(POC)FirsttimeInmanrFTIHlFirsttimeinpatientPK，PDThoroughQTcBioequivalence／bioavailabilityDrug-drugInteracfionCYP450SNPsFoodInteractionDrugInteractionSingleAscendingDoseMultipleAscendingDoseADMEJapaneseve

2、rsusCaucasianChlneseversusCaucasianDevicesanddeliverysysternso50beds，50studiesperyear，10-15FTIH0Audits：2FDA，1NIH，>50sponsorOJapaneseauthorityandTGAaudits2012№％㈣一cⅦa⋯onm⋯55NucleusNetwork—-a24／7operationoCorporateandfinance(6)oBusinessdevelopment(210Qualityand

3、training(4)OPIandmedical0fficers(61ONursesandwardstaff(20，includingcasuals)OResearchco—ordinators(15)oLaboratory(8)。Recruitmentandscreening(6)恤u5咖^一(Ⅶa～bon岫⋯劈，，＼陲万方数据StaffTrainingPhase1isdifferent：ODocumentedtrainingmandatoryOPrincipa

4、InvestigatorOToxicology

5、，pharmacology(GLP)OOn—siteAPImanufacturefGMPlODocumentationandstudyconduct(ICHGCP)OMedicaI．nursingandIaboratorystaff。Dataentry(paperande·CRF)OKnowledgeofnationalandinternationalregulations56塾厂L万方数据57TheTeGeneroDisasterNorthwickParkHospital,London13March2006o

6、TGNl412。Monoclonalantibody，targetCD28，TcellactivatoroFirstTimeInHumanoTrialapprovedbyMHRAandlRBoSixmalevolunteersdosed01mg／kgIVin3-6minsoCytokinestormstartedafter90minsoA¨subjectsbecamecritically川oShock，renalfailure．respiratoryfailure，DICoAllSUbjectsrecovere

7、dbutonelostfingersandtoes⋯⋯⋯or∞～60n⋯⋯EMEAGuideline-FacilitiesCentreforClinicaIStudies0LocatedintertiaryhospitalprecinctwithA＆EDeptOHospitalemergencyresponseteams．CCU＆ICUOCardiactelemetrytoalIbedsOCallbelIservicetoallbedsOOxygen＆SUctionavailabletoallbedsOCras

8、htrolleyandresuscitationequipmentOEmergencydrugsuppliesODoctorsalIhaveACLStraining～ucbu5帅^⋯e∞I“nco惭cec％m—r2∞宕)万方数据58万方数据59