资源描述：
《Silicone Oil Microdroplets and Protein Aggregates in Repackaged Bevacizumab and Ranibizumab Effects of Long-term Storage and Product Mishandling》由会员上传分享，免费在线阅读，更多相关内容在学术论文-天天文库。
1、RetinaSiliconeOilMicrodropletsandProteinAggregatesinRepackagedBevacizumabandRanibizumab:EffectsofLong-termStorageandProductMishandling12322LuLiu,DavidA.Ammar,LindseyA.Ross,NareshMandava,MalikY.Kahook,1andJohnF.CarpenterPURPOSE.Toquantifylevelsofsubvisiblepa
2、rticlesandprotein(InvestOphthalmolVisSci.2011;52:10231034)DOI:aggregatesinrepackagedbevacizumabobtainedfromcom-10.1167/iovs.10-6431poundingpharmacies,aswellasinsamplesofbevacizumabandranibizumabtestedincontrolledlaboratoryexperiments.evacizumab(Avastin;Gene
3、ntechTechnology,Inc.,SouthMETHODS.RepackagedbevacizumabwaspurchasedfromfourBSanFrancisco,CA)isarecombinanthumanmonoclonalexternalcompoundingpharmacies.Forcontrolledlaboratoryantibodythatinhibitsendothelialcellgrowthandsubsequentstudies,bevacizumabandplacebo
4、weredrawnintoplasticvascularization.Itwasapprovedforintravenous(IV)treatmentsyringesandincubatedat20°C,4°C,androomtemperatureofmetastaticcolorectalcancerbytheUnitedStatesFoodand(withandwithoutexposuretolight)for12weeks.Inaddition,DrugAdministration(FDA)in2
5、004andsubsequentlyhasbeenmechanicalshockoccurringduringshippingwasmimickedapprovedforIVtreatmentofnonsmallcelllungcancer,met-astaticbreastcancer,glioblastoma,andmetastatickidneycan-withsyringescontainingbevacizumab.Particlecountsandsizecer.Becauseofitsantiv
6、ascularactivity,bevacizumabhasalsodistributionswerequantifiedbyparticlecharacterizationtech-beenusedbyophthalmologistsfortheoff-labeltreatmentofnology.Levelsofmonomerandsolubleaggregatesofbevaci-wetage-relatedmaculardegeneration(AMD).Thispracticehaszumabwere
7、determinedwithsize-exclusionhigh-performancegrownrapidlybecauserepackagedbevacizumabhasbeenveryliquidchromatography(SE-HPLC).1effectiveintreatingAMDandbecausethecostperdoseofRESULTS.Repackagedbevacizumabfromthecompoundingbevacizumabissubstantiallylowerthant
8、hatofranibizumabpharmacieshadawiderangeofparticlecounts(89,006(Lucentis;Genentech),whichisanFDAapprovedanti-VEGF56,406to602,06218,349/mL).Bevacizumabsampleddi-agentspecificallypackagedandsoldforthetre
