第1章药理学总论-绪言-文档资料.pptVIP

25)Idea-to-newmedicineroad-FullDevelopmentphaseInthisFullDevelopmentstage,knownasPhaselll,severalthousandpatientswiththeparticulardiseasereceivethedrugincarefullycontrolledstudiestotestitssafety,tolerability,andefficacy.Finally,ifthecompoundhasproveditsworthinallthesetests,itenterstheRegistrationphaseinwhichthedataofitsentirehistoryarecompiledandanalyzedinaregulatorysubmission.ThisNewDrugApplication,orNDA,issubmittedtotheFDAforreview.Inparallel,aMarketingAuthorizationApplication(MAA)isfiledinEuro