药物研发的全过程

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1、药物研发的全过程带着猫咪去钓鱼药物研发的全过程药物研发的全过程流程图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药物研发的全过程带着猫咪去钓鱼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.参考：http://www

8、.nature.com/nrd/journal/v3/n10/fig_tab/nrd1523_F1.html药物从最初的实验室研究到最终摆放到药柜销售平均需要花费12年的时间。进行临床前试验的5000种化合物中只有5种能进入到后续的临床试验，而仅其中的1种化合物可以得到最终的上市批准。　　总的来说新药的研发分为两个阶段：研究和开发。这两个阶段是相继发生有互相联系的。区分两个阶段的标志是候选药物的确定，即在确定候选药物之前为研究阶段，确定之后的工作为开发阶段。所谓候选药物是指拟进行系统的临床前试验