制藥專業(yè)英語(yǔ)原文翻譯

一、Digitalisisoneofthemostfrequentlyusedmedicationsinthetreatmentofheartfailureandarrhythmia.Itincreasestheoftheheartmuscleandmodifiesvascularresistance.Italsoslowsconductionthroughtheatrioventricularnodeintheheart,makingitusefulinthetreatmentofatrialfibrillationandotherrapidheartrhythms其他快速心律二、Theformulationofaparenteralproductinvolvesthecombinationofoneormoreingredientswithamedicinalagenttoenhancetheconvenience，acceptability，oreffectivenessoftheproduct.Rarelyisitpreferabletodispenseadrugsinglyasasteriledrypowderunlesstheformulationofastablepreparationisnotpossible非腸道用產(chǎn)品的配方涉及一個(gè)或更多組成部份間的結(jié)合，這些組成部份（各自）都含有一種用以提高產(chǎn)品方便性、可同意性或療效的有效成份。（人們）很少情愿把藥物僅僅以一種無(wú)菌的、干燥的粉末（的形式）配售，除非（把它做成）穩(wěn)固的液體制劑的配方是行不通的。3、Production生產(chǎn)Theproductionprocessincludesallofthestepsfromtheaccumulationandcombiningoftheingredientsoftheformulatotheenclosingofproductintheindividualcontainerfordistribution.Intimatelyassociatedwiththeseprocessesarethepersonnelwhocarrythemoutandthefacilitiesinwhichtheyareperformed.Themostideallyplannedprocessescanberenderedineffectivebypersonnelwhodonothavetherightattitudeortraining，orbyfacilitiesthatdonotprovideanefficientlycontrolledenvironment.生產(chǎn)進(jìn)程包括從配方的各個(gè)組成部份的積聚和結(jié)合到產(chǎn)品封裝入用于分售人員或不能提供一個(gè)有效的操縱環(huán)境的設(shè)備而變得無(wú)效。Toenhancetheassuranceofsuccessfulmanufacturingoperation，allprocessstepsmustbecarefullyreducedtowritingafterbeingshownbeeffective.Thesewrittenprocessstepsareoftencalledstandard.operatingprocedures(SOPs)⑥.Noextemporaneouschangesarepermittedtobemadeintheseprocedures;anychangemustgothroughthesameapprovalstepsastheoriginalwrittenSOP.Further，extensiverecordsmustbekepttogiveassuranceattheendoftheproductionprocessthatallstepshavebeenperformedasprescribed，anaspectemphasizedintheFDA'sGoodManufacturingPractices.Suchin-processcontrolisessentialtoassuringthequalityoftheproduct，sincetheseassurancesareevenmoresignificantthanthosefromproductreleasetesting.Theproductionof.aqualityproductisaresultofthecontinuous,dedicatedeffortofthequalityassurance，production，andqualitycontrolpersonnelwithintheplantindeveloping，performing，andconfirmingeffectivesops（SOPs這些規(guī)程是不許諾進(jìn)行臨時(shí)改動(dòng)的,任何改動(dòng)都必需通過(guò)和原有的書(shū)面規(guī)程一樣SOP4、Reactortechnologycomprisestheunderlyingprinciplesofchemicalreactionengineering(CRE)andthepracticesusedintheirapplication.Thefocusesofreactortechnologyarereactorconfigurations，operatingconditions，externaloperatingenvironmentsdevelopmentalhistoryindustrialapplication，andevolutionarychange.Reactordesignsevolvefromthepursuitofnewproductsanduses，higherconversion，morefavorablereactionselectivity，reducedfixedandoperatingcosts，intrinsicallysafeoperation，andenvironmentallyacceptableprocessing（CRE5、Drugdevelopmentaimstoproduceanoveltherapeuticagentwhichsuperiorinefficacytoexistingremediesandwhichcauseslessfrequentorlesssevereadverseeffects.藥物研制旨在生產(chǎn)出在療效上優(yōu)于現(xiàn)存藥品，且副作用發(fā)生率減少、程度降低的新型醫(yī)治藥物。六、Phase1involvessmallscalestudiesinnormalvolunteers.Thesestudiesshoulddeterminewhetherthedrugcanbegiventomanwithoutserioussymptomsortoxicity,andwhetherithasdesiredpharmacologicaleffects.Thesestudiesoftenbeginwithadoserangingstudy,using1/50to1/100theeffectivedoseinanimalsandincreasinguntiltheeffect,oradverseeffects,areseen.Thesestudiesshouldonlybeperformedonvolunteerswhoareinformedabouttheimplicationsofthetests,andwhogivetheirconsentfreelyStudiesshouldincludeassessmentofclinical,haematologicalevidencebeforeandafterdrugadministrationtoidentifypharmacologicalactionsandadverseeffects.Phase1studiesshouldonlybeperformedbyexperiencedstaff,undermedicalsupervision,andinpremiseswithappropriateresuscitativefacilitiesandsupport.1/100到1/50救設(shè)備和蘇醒技術(shù)的支持。Phase2studiesdeterminewhetherthenewdrughasthedesiredeffectonpatientswiththeappropriatedisease.InBritaintheseinvestigationscanbeperformedonlyaftersubmissionofpreclinicalandphase1resultstotheCommitteeonSafetyofMedicines.Thisbodyeitherissuesaclinicaltrialcertificate(CTC)orauthorizeslimitedclinicaltrialsunderanexemptionprocedure(CTE).Phase2studiesinitiallymaybeopen,uncontrolled,dose-rangingexperimentsbutshouldincludecontrolledstudiesundersingleorDouble-blindconditions.theymayinvolvecomparisonswithinactiveplaceboorknownactiveagents.(CTC)或依照寬免做法服用非活性安慰劑或已知的活性藥物的對(duì)照組。Phaseresultsoftherapeuticefficacyandsafetyjustifyit,nextstepisprogressiontolargescaleclinicaltrialstodeterminehowthenewdrugcompareinclinicalpracticewithexistingremedies,andtoestablishitsprofileofactionandfrequencyofadverseeffects.AfterPhase3studiestheevidencefromallofdevelopmentisassembledandiftheconclusionsindicateausefulaction,thedrugmaybesubmittedtotheregulatoryauthoritieswitharequestforaproductlicense.Phase4Anewdrugisusuallymarketedafteronlyafewhundred,orthemostafewthousand,patientshavebeenexposedtoitforarelativelyshortperiod(weeksormonths).Post-marketingsurveillanceisincreasinglyundertakentoassessefficacyandtoxicityofnewdrugsalargescale.NouniformschemeforPhase4supervisionhasyetbeenestablished,butfewdoubtthenecessityofcollectingthisinformationonlow-frequencyadverseeffects第四時(shí)期：一個(gè)新的藥物一般是上市后僅過(guò)了幾百年，或在最幾千年，患者接觸到藥物的時(shí)刻都相對(duì)較短（數(shù)周或數(shù)月?lián)嗽u(píng)估新藥的療效和毒性的方式。對(duì)第四時(shí)期的監(jiān)管盡管沒(méi)有規(guī)定統(tǒng)一的操作，但很少有人疑心搜集時(shí)期低頻副作用的必要性7、Undercurrentlaw,allnewdrugsneedproofthattheyareeffective,aswellassafe,beforetheycanbeapprovedformarketing.Butit’simportanttorealizethatnodrugisabsolutelysafe.Thereisalwayssomeriskofanadversereaction.It’swhenthebenefitsoutweighthethatFDAconsidersadrugsafeenoughtoapprove.8、Fullreportsofadrug’sstudiesmustbesubmittedbecausetheyarethebasisofFDA’sevaluationofsafetyandeffectiveness.Thecontrolledclinicaltrialsareespeciallyimportantbecausetheyinvolvethegreatestnumberofpatients.FDA礎(chǔ)。有對(duì)照組的臨床實(shí)驗(yàn)尤其重要因?yàn)樯婕氨姸嗖∪恕yprovidingfortheappropriatecomparisonstojudgethedrug’seffectivenessandbyrevealinglesscommon(evenrare)sideeffectsadversereactions,theyhelptoclarifythedrug’sbenefit-to-riskrelationship.Thefinalhumanstudiesalsogenerateinformationthatwillbeinthedrug’sprofessionallabeling,theguidanceapprovedbyFDAonhowtousethedrug.Thisisthepackageinsertthataccompaniesainallshipmentstophysiciansandpharmacies.通過(guò)提供適當(dāng)?shù)谋容^，以判定藥物的有效性，并揭露不常見(jiàn)（乃至罕有的）副FDA的指導(dǎo)。這是伴隨著藥物在所有出貨給醫(yī)生和藥店的藥品說(shuō)明書(shū)。九、AnytimeduringanNDAreview,FDAmaycontactthesponsorortheinvestigatorstodiscussproblemsconcerningthedata隨時(shí)在NDA的審查，F(xiàn)DA可能與保薦人或調(diào)查人員討論有關(guān)數(shù)據(jù)的問(wèn)題Indeed,FDAstaffmayvisitthesitesofsomeofthestudiestoresultsprovidedintheNDAwiththephysicians’patientrecords.IftherearemajordeficiencieswithanypartoftheNDA,substantiallymoreworkbythesponsormaybeneeded.事實(shí)上，F(xiàn)DANDANDA的工作。FDAfrequentlyasksoneofits17standingadvisorycommitteesonandbiologicsforadvice.Thisisespeciallytruewhenanapprovaldecisionisa“closecall”.FDA17不是批準(zhǔn)的決定“千鈞一發(fā)”時(shí)，更是如此。Inthefinalanalysis,FDA’sdecisionwhethertoapproveanewdrugformarketingboilsdowntotwoquestions在最后的分析中，F(xiàn)DADotheresultsprovidesubstantialevidenceofeffectiveness?Thismaybeeasytofigureoutinastudywithadrugtotreatbloodpressure—ifthedrugworks,thebloodpressuregoesdown.Butotherstudies,suchasthosetestingadrugtotreatdepression,aremorecomplicated.請(qǐng)執(zhí)行結(jié)果的有效性提供了大量的證據(jù)？這可能很容易弄清楚與藥物來(lái)醫(yī)治高血壓，若是藥物工程研究，血壓下降。但其他研究中，如那些測(cè)試一種藥物來(lái)醫(yī)治抑郁癥，比較復(fù)雜。Dotheresultsshowtheproductissafeundertheconditionsofintheproposedlabeling?Reviewersnotewhethertheadversereactionsshowan