藥物研發(fā)的全過程

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1、藥物研發(fā)的全過程帶著貓咪去釣魚藥物研發(fā)的全過程藥物研發(fā)的全過程流程圖Thedrugdiscoveryprocessbeginswiththeidentificationofamedicalneed,includingajudgementontheadequacyofexistingtherapies(ifthereareany).Fromthisanalysis,togetherwithanappraisalofthecurrentknowledgeaboutthetargetdisease,w

2、illcomehypothesesonhowtopossiblyimprovetherapy—thatis,whatefficacy,safetyormechanisticallynovelimprovementswilladvancethemethodofdrugtreatmentforpatientswiththetargetdisease?Onthebasisofthesehypotheses,specificobjectiveswillbesetfortheproject.Then,te

3、stingselectedchemicalsinappropriatebiologicaltestscanbegin.Keysubsequentstepsintheprocessincludedetectingrelevantbiologicalactivity(a'hit')forastructurallynovelcompound?invitro,thenfindingarelatedcompoundwith?invivo?activityinanappropriateanimalmodel

4、,followedbymaximizingthisactivity藥物研發(fā)的全過程帶著貓咪去釣魚throughthepreparationofanalogousstructures,andfinallyselectingonecompoundasthedrugdevelopmentcandidate.Thisdrugcandidatethenundergoestoxicologicaltestinginanimals,asrequiredbylaw.Ifthecompoundpassesallt

5、hesetests,alltheaccumulatedresearchdataareassembledandsubmittedasanInvestigationalNewDrugApplication(IND)totheFoodandDrugAdministration(FDA)intheUnitedStates(orcomparableagencyinothercountries)beforeclinicaltrialsareinitiated.Intheclinic,thereisseque

6、ntialevaluationinnormalhumanvolunteersoftoleration(PhaseI),efficacyanddoserangeinpatients(PhaseII),followedbywidespreadtrialsinthousandsofappropriatepatientstodevelopabroaddatabaseofefficacyandsafety.Forthefew(4–7%)drugcandidatesthatsurvivethisseries

7、ofdevelopmenttrials,aNewDrugApplication(NDA)thatcontainsalltheaccumulatedresearchdataisfiledforthoroughreviewbytheexpertsattheFDA.Onlywiththeirapprovalcanthenewdrugbeofferedtodoctorsandtheirpatientstotreatthediseaseforwhichitwasdesigned.參考：http://www

8、.nature.com/nrd/journal/v3/n10/fig_tab/nrd1523_F1.html藥物從最初的實驗室研究到最終擺放到藥柜銷售平均需要花費12年的時間。進行臨床前試驗的5000種化合物中只有5種能進入到后續(xù)的臨床試驗，而僅其中的1種化合物可以得到最終的上市批準。　　總的來說新藥的研發(fā)分為兩個階段：研究和開發(fā)。這兩個階段是相繼發(fā)生有互相聯(lián)系的。區(qū)分兩個階段的標志是候選藥物的確定，即在確定候選藥物之前為研究階段，確定之后的工作為開發(fā)階段。所謂候選藥物是指擬進行系統(tǒng)的臨床前試驗