制药专业英语原文翻译

一、Digitalisisoneofthemostfrequentlyusedmedicationsinthetreatmentofheartfailureandarrhythmia.Itincreasestheoftheheartmuscleandmodifiesvascularresistance.Italsoslowsconductionthroughtheatrioventricularnodeintheheart,makingitusefulinthetreatmentofatrialfibrillationandotherrapidheartrhythms其他快速心律二、Theformulationofaparenteralproductinvolvesthecombinationofoneormoreingredientswithamedicinalagenttoenhancetheconvenience，acceptability，oreffectivenessoftheproduct.Rarelyisitpreferabletodispenseadrugsinglyasasteriledrypowderunlesstheformulationofastablepreparationisnotpossible非肠道用产品的配方涉及一个或更多组成部份间的结合，这些组成部份（各自）都含有一种用以提高产品方便性、可同意性或疗效的有效成份。（人们）很少情愿把药物仅仅以一种无菌的、干燥的粉末（的形式）配售，除非（把它做成）稳固的液体制剂的配方是行不通的。3、Production生产Theproductionprocessincludesallofthestepsfromtheaccumulationandcombiningoftheingredientsoftheformulatotheenclosingofproductintheindividualcontainerfordistribution.Intimatelyassociatedwiththeseprocessesarethepersonnelwhocarrythemoutandthefacilitiesinwhichtheyareperformed.Themostideallyplannedprocessescanberenderedineffectivebypersonnelwhodonothavetherightattitudeortraining，orbyfacilitiesthatdonotprovideanefficientlycontrolledenvironment.生产进程包括从配方的各个组成部份的积聚和结合到产品封装入用于分售人员或不能提供一个有效的操纵环境的设备而变得无效。Toenhancetheassuranceofsuccessfulmanufacturingoperation，allprocessstepsmustbecarefullyreducedtowritingafterbeingshownbeeffective.Thesewrittenprocessstepsareoftencalledstandard.operatingprocedures(SOPs)⑥.Noextemporaneouschangesarepermittedtobemadeintheseprocedures;anychangemustgothroughthesameapprovalstepsastheoriginalwrittenSOP.Further，extensiverecordsmustbekepttogiveassuranceattheendoftheproductionprocessthatallstepshavebeenperformedasprescribed，anaspectemphasizedintheFDA'sGoodManufacturingPractices.Suchin-processcontrolisessentialtoassuringthequalityoftheproduct，sincetheseassurancesareevenmoresignificantthanthosefromproductreleasetesting.Theproductionof.aqualityproductisaresultofthecontinuous,dedicatedeffortofthequalityassurance，production，andqualitycontrolpersonnelwithintheplantindeveloping，performing，andconfirmingeffectivesops（SOPs这些规程是不许诺进行临时改动的,任何改动都必需通过和原有的书面规程一样SOP4、Reactortechnologycomprisestheunderlyingprinciplesofchemicalreactionengineering(CRE)andthepracticesusedintheirapplication.Thefocusesofreactortechnologyarereactorconfigurations，operatingconditions，externaloperatingenvironmentsdevelopmentalhistoryindustrialapplication，andevolutionarychange.Reactordesignsevolvefromthepursuitofnewproductsanduses，higherconversion，morefavorablereactionselectivity，reducedfixedandoperatingcosts，intrinsicallysafeoperation，andenvironmentallyacceptableprocessing（CRE5、Drugdevelopmentaimstoproduceanoveltherapeuticagentwhichsuperiorinefficacytoexistingremediesandwhichcauseslessfrequentorlesssevereadverseeffects.药物研制旨在生产出在疗效上优于现存药品，且副作用发生率减少、程度降低的新型医治药物。六、Phase1involvessmallscalestudiesinnormalvolunteers.Thesestudiesshoulddeterminewhetherthedrugcanbegiventomanwithoutserioussymptomsortoxicity,andwhetherithasdesiredpharmacologicaleffects.Thesestudiesoftenbeginwithadoserangingstudy,using1/50to1/100theeffectivedoseinanimalsandincreasinguntiltheeffect,oradverseeffects,areseen.Thesestudiesshouldonlybeperformedonvolunteerswhoareinformedabouttheimplicationsofthetests,andwhogivetheirconsentfreelyStudiesshouldincludeassessmentofclinical,haematologicalevidencebeforeandafterdrugadministrationtoidentifypharmacologicalactionsandadverseeffects.Phase1studiesshouldonlybeperformedbyexperiencedstaff,undermedicalsupervision,andinpremiseswithappropriateresuscitativefacilitiesandsupport.1/100到1/50救设备和苏醒技术的支持。Phase2studiesdeterminewhetherthenewdrughasthedesiredeffectonpatientswiththeappropriatedisease.InBritaintheseinvestigationscanbeperformedonlyaftersubmissionofpreclinicalandphase1resultstotheCommitteeonSafetyofMedicines.Thisbodyeitherissuesaclinicaltrialcertificate(CTC)orauthorizeslimitedclinicaltrialsunderanexemptionprocedure(CTE).Phase2studiesinitiallymaybeopen,uncontrolled,dose-rangingexperimentsbutshouldincludecontrolledstudiesundersingleorDouble-blindconditions.theymayinvolvecomparisonswithinactiveplaceboorknownactiveagents.(CTC)或依照宽免做法服用非活性安慰剂或已知的活性药物的对照组。Phaseresultsoftherapeuticefficacyandsafetyjustifyit,nextstepisprogressiontolargescaleclinicaltrialstodeterminehowthenewdrugcompareinclinicalpracticewithexistingremedies,andtoestablishitsprofileofactionandfrequencyofadverseeffects.AfterPhase3studiestheevidencefromallofdevelopmentisassembledandiftheconclusionsindicateausefulaction,thedrugmaybesubmittedtotheregulatoryauthoritieswitharequestforaproductlicense.Phase4Anewdrugisusuallymarketedafteronlyafewhundred,orthemostafewthousand,patientshavebeenexposedtoitforarelativelyshortperiod(weeksormonths).Post-marketingsurveillanceisincreasinglyundertakentoassessefficacyandtoxicityofnewdrugsalargescale.NouniformschemeforPhase4supervisionhasyetbeenestablished,butfewdoubtthenecessityofcollectingthisinformationonlow-frequencyadverseeffects第四时期：一个新的药物一般是上市后仅过了几百年，或在最几千年，患者接触到药物的时刻都相对较短（数周或数月担了评估新药的疗效和毒性的方式。对第四时期的监管尽管没有规定统一的操作，但很少有人疑心搜集时期低频副作用的必要性7、Undercurrentlaw,allnewdrugsneedproofthattheyareeffective,aswellassafe,beforetheycanbeapprovedformarketing.Butit’simportanttorealizethatnodrugisabsolutelysafe.Thereisalwayssomeriskofanadversereaction.It’swhenthebenefitsoutweighthethatFDAconsidersadrugsafeenoughtoapprove.8、Fullreportsofadrug’sstudiesmustbesubmittedbecausetheyarethebasisofFDA’sevaluationofsafetyandeffectiveness.Thecontrolledclinicaltrialsareespeciallyimportantbecausetheyinvolvethegreatestnumberofpatients.FDA础。有对照组的临床实验尤其重要因为涉及众多病人。Byprovidingfortheappropriatecomparisonstojudgethedrug’seffectivenessandbyrevealinglesscommon(evenrare)sideeffectsadversereactions,theyhelptoclarifythedrug’sbenefit-to-riskrelationship.Thefinalhumanstudiesalsogenerateinformationthatwillbeinthedrug’sprofessionallabeling,theguidanceapprovedbyFDAonhowtousethedrug.Thisisthepackageinsertthataccompaniesainallshipmentstophysiciansandpharmacies.通过提供适当的比较，以判定药物的有效性，并揭露不常见（乃至罕有的）副FDA的指导。这是伴随着药物在所有出货给医生和药店的药品说明书。九、AnytimeduringanNDAreview,FDAmaycontactthesponsorortheinvestigatorstodiscussproblemsconcerningthedata随时在NDA的审查，FDA可能与保荐人或调查人员讨论有关数据的问题Indeed,FDAstaffmayvisitthesitesofsomeofthestudiestoresultsprovidedintheNDAwiththephysicians’patientrecords.IftherearemajordeficiencieswithanypartoftheNDA,substantiallymoreworkbythesponsormaybeneeded.事实上，FDANDANDA的工作。FDAfrequentlyasksoneofits17standingadvisorycommitteesonandbiologicsforadvice.Thisisespeciallytruewhenanapprovaldecisionisa“closecall”.FDA17不是批准的决定“千钧一发”时，更是如此。Inthefinalanalysis,FDA’sdecisionwhethertoapproveanewdrugformarketingboilsdowntotwoquestions在最后的分析中，FDADotheresultsprovidesubstantialevidenceofeffectiveness?Thismaybeeasytofigureoutinastudywithadrugtotreatbloodpressure—ifthedrugworks,thebloodpressuregoesdown.Butotherstudies,suchasthosetestingadrugtotreatdepression,aremorecomplicated.请执行结果的有效性提供了大量的证据？这可能很容易弄清楚与药物来医治高血压，若是药物工程研究，血压下降。但其他研究中，如那些测试一种药物来医治抑郁症，比较复杂。Dotheresultsshowtheproductissafeundertheconditionsofintheproposedlabeling?Reviewersnotewhethertheadversereactionsshowan