NAPSR/CNPR EXAM QUESTIONS WITH
CORRECT ANSWERS
PharmaacompaniesamustasubmitaextensiveadataatoatheaFDAademonstratingatheasafetyaanda
effectivenessaofanewadrugsabeforeareceivingaapprovalaforasale.a-aans--True
Averageareviewatimeaforaaanewadruga-aans--18amonths
SalesaTeama-aans--Pga7
Thea"engineaofainnovation,"afocusedaonadiscoveringaorainventingapromisinganewaproduct.a-
aans--Researcha&aDevelopment
Thisaincludesasupplyachain,amanufacturing,atrade,aandadistributionafunctionsaofatheabusine
ss.a-aans--Manufacturinga&aOperations
Ina2012,aFDAaregulatorsaapproveda39anewadrugsaforauseainatheaU.S.a-aans--True
3,070anewamedsaareainadevelopmentaforacancer.a-aans--True
DefineaOff-labela-aans--
Usageaofaaamedicationaforapurposesaotherathanatheaspecificaonesaappearingaonathealabel
Toxicitya-aans--
Theaextent,aquality,aoradegreeatoawhichaaasubstanceaisapoisonousaoraharmfulatoatheabody
InstitutionalareviewaBoarda(IRB)a-aans--
Aacommitteeaofaphysicians,astaticians,acommunityaadvocated,aandaothersawhichaensureath
ataaaclinicalatrialaisaethicalaandathatathearightsaofatheastudyaparticipantsaareaprotected.aAllaclin
icalatrialsamustabeaapprovedabyaanaIRBabeforeatheyabegin.
Placeboa-aans--Inactiveapill,aliquid,aorapowderathatahasanoatreatmentavalueaakaasugarapill
Edemaa-aans--Swelling
Asymptomatica-aans--Withoutasignsaorasymptoms
ClinicalaPharmacologya-aans--
Theastudyaofatheaeffectsaandamovementaofadrugsainatheahumanabody
Anatomya-aans--Theastudyaofabasicastructuresaofatheabody
,Physiologya-aans--Theastudyaofahowathoseabodyastructuresafunction
Basicaclinicalapharmacologyainvolvesa3amainaconceptsa-aans--
Pharmacodynamics,aPharmacokinetics,adrugadistributionaandaelimination.
Pharmacodynamicsa-aans--
Studyaofatheabiochemicalaandaphysiologicalaeffectsaofadrugsaandatheiramechanismsaofaactio
nai.e.atheastudyaofawhataaadrugadoesatoatheabody.aItadescribesatheatherapeuticaeffectsaofadru
gsa(painarelief,abloodapressureareduction,atheirasideaeffectsaandatheirasitesaofaaction.
Pharmacokineticsa-aans--
Studyaofahowaaadrugaisaprocessedabyatheabody,awithaemphasisaonatheatimearequiredaforaabs
orption,adurationaofaaction,adistribution,aandamethodaofaexcretion.aTheastudyaofahowatheabo
dyaaffectsadrugs.
Drugadistributiona&aeliminationa-aans--
Drugadeliveryasystems,arouteaofaadministrationa,amodesaofaexcretion.
Plasmaa-aans--Thealiquidaportionaofatheabloodathatacarriesaproteinsaandaotherasubstances
Organsa-aans--
Specializedacellsaandatissuesagroupedatogetheratoaperformaspecificabodyafunctionaforaaaco
mmonapurpose.a(Kidney,aheart,aintestines,aandaskin)
Nucleusa-aans--Brainaofatheacellathataregulatesaallaactivities.
Proteinsa-aans--Aanutrientamadeaupaofaofachainsaofaaminoaacids
Fatsa-aans--Aanutrientastoredainaspecialabodyatissuesaasaaagreatasourceaofareserveaenergy
Carbohydratesa-aans--
Aanutrientathataisatheabody'saimmediateasourceaofaenergy.aIt'sabrokenadownatoaglucoseaanda
usedaforaimmediateametabolicareactions.
Vitaminsa-aans--
Aanutrientasubstanceanecessaryaforagrowth,adevelopment,aandanormalaregulationaofametab
olicaprocesses.aMustabeatakenafromaoutsideatheabody.
Mineralsa-aans--Aanutrientanecessaryaforabodilyapurposesasuchaasatheabalanceaofabodyafluid
WateraisaNOTaaanutrienta-aans--True
Body'saMajoraSystemsa-aans--
Cardiovascular,aRespiratory,anervous,amusculoskeletal,areproductive,aimmune
, Absorptiona-aans--
Howatheadrugapassesafromaitsasideaofaadministrationaintoatheabloodstream
Distributiona-aans--
Howatheadrugaisadispersedaamongatheaorgansaafteraabsorptionaintoatheablood
Metabolisma-aans--Howatheaactiveapartaofaaadrugaisametabolizedaintoaaamoreawater-
solubleacompoundathatacanabeareadilyaexcretedabyatheakidneys
Excretiona-aans--
Howatheadrugaisaeliminatedafromatheabody.aUsuallyadrugsaareaeliminatedaviaaurine.aTheyaca
naalsoabeaexcretedathroughathealungs,askin,aorabreastamilk.
Itatakesaabouta10ayearsaforaaadrugatoahitatheamarketa-aans--True
Routesaofadrugaadministrationa-aans--Pga26-29
Sevenarightsaofadrugaadministrationa-aans--pga30
Bioavailabilitya-aans--
howaquicklyaandahowamuchaofaaadrugareachesaitsaintendedatargetasiteaofaaction
Bioequivalenta-aans--
whenatheyacontainatheasameaactiveaingredientsaandaproceedavirtuallyatheasameabloodalevel
saoveratime.
Therapeuticaequivalencea-aans--Productionaofatheasameamedicinalaeffect
DrugaeliminationaandaExcretiona-aans--pga34
DrugaFormsa-aans--Pga35-38
Patentalasta20ayearsa-aans--True
Inactiveaingredientsa-aans--
Addedatoaprovideabulk,astrength,aaidadissolving,acolor,ataste,aetc.aIAsadoanotaaffectatheabody
PharmaceuticalaIngredientsa-aans--Pga54
BIDa-aans--twiceaaaday
Cmaxa-aans--Peakaplasmaaconcentrationaonaaameasuringacurve
Half-lifea-aans--
Periodaofatimeaitatakesaforaaaspecificaamountaofadrugainatheabodyatoabeareduced,athroughathe
aexcretionaoraeliminationaprocess,atoaexactlyaone-half athataoriginalaamount