CNPR, NAPSR EXAM QUESTIONS WITH
CORRECT ANSWERS
DrugsDiscoverys-sans--
•sUnlikessmallsmoleculesdrugss(pharmaceuticals),slargesmoleculesdrugss(biopharmaceutic
als)saresmainlysprotein-based
osThesesprotein-
basedsdrugssaressimilarstosnaturalsbiologicalscompoundssfoundsinshumansbodysorsthey'resf
ragmentssthatsmimicsactivespartsofsnaturalscompounds
DiscoverysofsPharmaceuticalss-sans--
commencessw/sscanningshundredssofscompounds,swhethersw/sactualsmaterialss(irrational
sapproach)sorsvirtualssimulationss(rationalsapproach)
•sPharmaceuticalssaresnewschemicalsentitiess(NCE)sandsaresproduceds(synthesized)sinsm
anufacturingsplantssusingstechniquessbasedsonschemicalsreactionssofsreactants
DiscoverysofsBiopharmaceuticalss-sans--
researchersshavestosexaminescompoundssw/inshumans
osEx.sHormonessorsothersbiologicalsresponsesmodifierssandshowstheysaffectsbiologicalspro
cesses
osInssomescases,sstudyspathogensssuchsassinfluenzasvirussorsbacteriastosderivesvaccines
osInsotherscases,sresearchersscopysthesesbiologicalsresponsesmodifierssandsusesthemsass
replacementstherapy
osProtein-
basedsdrugssaresmanufacturedsinsbiologicalssystems,ssuchsasslivingscells,sproducingsdesir
edsproteinsmoleculessinslargesreactionsvesselssorsbysextractionsfromsanimalsserum
osBecomingsincreasinglysimportant
•sMorespotentsandsspecific—
moressimilarstosproteinssw/insbodysthereforesmoreseffectivesinstreatingsoursdiseases
AreassofsBiopharmaceuticalss-sans--•sProphylactic→spreventivesassinsvaccines
•sTherapeutic→santibodies
•sReplacementstherapy→shormones,sgrowthsfactors
Biologicss-sans--FDAsdefinitionsis:
osBiologicalsproductssubjectstoslicensuresundersPublicsHealthsServicesActsissanysvirus,sthe
rapeuticsserum,stoxin,santitoxin,svaccine,sblood,sasbloodscomponentsorsderivative,sallerge
nicsproduce,sorsanalogoussproduct,sapplicablestosprevention,streatmentsorscuresofsdisease
ssorsinjuriesstoshumans.sBiologicalsproductssinclude,sbutsaresnotslimitedsto,sbacterialsandsvi
ralsvaccines,shumansbloodsandsplasmasandstheirsderivatives,sandscertainsproductssproduc
,edsbysbiotechnology,ssuchsassinterferonssandserythropoietins.sBiologicssencompasssman
ysdifferentsprotein-
basedsdrugs,sandsincludesbloodsproductsssuchsassclottingsfactorssextractedsfromsblood.
Vacciness-sans--
•sBasissofsvaccinationsissthatsadministeringssmallsquantitysofsasvaccines(antigensthatshassb
eenstreated)sstimulatessoursimmunessystemsandscausessantibodiesstosbessecretedstosreac
tsagainstsforeignsantigen
•sLatersinslife,swhenswesencountersanothersexposurestossamesantigen,soursimmunessyste
mswillsevokesasmemorysresponsesandsactivatesdefensesmechanismssbysgeneratingsantibo
diesstoscombatsinvadingsantigen
•sContainssantigenicscomponentssthatsaresobtainedsfromsorsderivedsfromspathogen
osIncludesmainlysviruses,sbacteria,sparasitessandsfungi
osResearchshassshownsthatspartsofspathogensthatscausessdiseases(virulence)scansbesdec
oupledsfromsprotectivesparts(immunity)
•sDevelopmentsfocusessonsmeansstosreducesvirulencesfactorswhilesretainingsimmunityssti
mulation
•sOralsorsparenteral
VaccinesPreparationss-sans--AttenuatedsVaccines
KilledsorsInactivatedsVaccines
Toxoids
AttenuatedsVacciness-sans--
•sVirulencesofspathogensthatscansbesreducedsinsnumbersofsways
•sByschemicalstreatment,sbystemperaturesadaptation,sorsbysgrowingspathogensinsspecifieds
othersthansnaturalshosts(passaging)
•sAdvantagessareslowscostspreparation,selicitsdesiredsimmunologicalsresponse,sandsnorm
allyssinglesdosesisssufficient
•sDisadvantagessarespotentialstosrevertstosvirulencesandslimitedsshelfslife
KilledsorsInactivatedsVacciness-sans--
•sChemicalsandstemperaturestreatmentsaresnormallysusedstoskillsorsinactivatespathogen
•sFormaldehydestreatmentsmostscommonsmethod
•sOtherschemicalssusedsaresphenolsandsacetone
•sAnothersmethodsisstosirradiatespathogenstosrendersitsinactive
•sAdvantagessaresnon-reversalstosvirulencesandsrelativelysstablesshelfslife
•sDisadvantagessareshigherscostsofsproduction,smorescontrolsissrequiredsforsproductionstos
ensuresreliablesprocessessforscompletesinactivationsandstheresisspossibilitysofsreducedsim
munologicalsresponsesduestostreatmentsprocessesssosmultiplesboostersvaccinationssmays
besrequired
Toxoidss-sans--•sDerivedsfromstoxinsssecretedsbyspathogen
•sAdvantagessandsdisadvantagesssimilarstoskilledsorsinactivatedsvaccines(advantages:sno
n-
reversalstosvirulencesandsrelativelysstablesshelfslife;sdisadvantages:shigherscostsofsproduct
,ion,smorescontrolsissrequiredsforsproductionstosensuresreliablesprocessessforscompletesina
ctivationsandstheresisspossiblitysofsreducedsimmunologicalsresponsesduestostreatmentspro
cessesssosmultiplesboostersvaccinationssmaysbesrequired)
NewsVacciness-sans--
•sAdvancessinsgenomics,smolecularsbiologysandsrecombinantstechnologyshassprovidedsne
wsdirectionssforsdiscovery,sdevelopmentsandsmanufacturesofsvaccines
•sCurrentsapproachsissminimalistsstrategystosdecouplesvirulencesandsimmunitysfunctions
•sAimsisstosusesonlysimmunityspartstosconfersprotection,ssosvaccinesisssafestosbesadminister
ed
•sApproachscansbesdividedsintossubunit,svector-based,sDNAsandspeptidesvaccines
SubunitsVacciness-sans--•sUsesonlyspartsofsbacteriasorsvirussinsteadsofsentirespathogen
•sPartsissderivedsfromsoutsidesenvelopesproteinsofspathogen
•sRequiressknowledgesofsgenomessequencesofspathogensbysidentifyingsopensreadingsfra
mess(ORF)sthatspotentiallysencodesnovelsantigenicssurfacesproteinssknownsassepitopes,s
whichsbindstosantibodies
•sWhensidentified,sORFssaresclonedstosexpresssproteinsepitopessusingsself-
replicatingsplasmids
•sBindingspropertiessofsepitopesscansbesstudiedsusingsenzymeslinkedsimmunosorbentsass
ays(ELISA)sorsfluorescentsactivatedscellssorters(FACS)
•sLeadingscandidatessofsepitopessaresinjectedsintosanimalsstosdetermineswhetherstheyselic
itsanysantibodysresponse
osThosesthatsworksaresselectedsandsoptimizedstosbecomesvaccinescandidatessw/sfurtherst
estssbeforeshumansclinicalstrials
osAlsosworkingsonsmultiplesepitopessubunitsvaccinesswhichscansprovidesdifferentsantigenic
sbindingssites
Vector-basedsVacciness-sans--
•sVirusessandsbacteriasaresdetoxifiedsandsusedsassvehiclesstoscarrysvaccines
•sSubunitsvaccinessaresbeingsdeliveredsbyscarriersvehiclesstoselicitsimmunesresponse
•sMultiplestypessofsenvelopesproteinsscansbesdeliveredsw/sthissmethod
•sClinicalstrialssw/sthisstypesofsvector-basedsvaccinessaresbeingsinvestigated
DNAsVacciness-sans--•sAkasnucleicsvaccinessorsgeneticsimmunization
•sHosts(patient)sissdirectlysinjectedsw/sselectedsviralsgenesswhichscontainsengineeredsDNA
ssequencessthatscodesforsantigens
•sHostssownscellsstakesupsthesesgenessandsexpresssantigensswhichsaresthenspresentedsto
simmunescellssandsactivatesimmunesresponse
PeptidesVacciness-sans--•sChemicallyssynthesizedsandsnormallysconsistsofs8-
24saminosacids
•sRelativelyssmall
•sAkaspeptidomimeticsvaccinessasstheysmimicsepitopes
•sComplexsstructuressofscyclicscomponents,sbranchedschainsorsothersconfigurationsscansb
esbuiltsintospeptideschain
, •sTheyspossesssconformationsssimilarstosepitopessandscansbesrecognizedsbysimmunescell
s
•sAnsinssilicosvaccinesdesignsapproachshassbeensusedstosfindspotentialsepitopes
•sCriticalsaspectsofspeptidesvaccinessisstosproduces3Dsstructuresssimilarstosnativesepitopes
sofspathogen
Adjuvants-sans--
•sVaccinessformulatedsw/scertainssubstancesstosenhancesimmunesresponse
•sLatinsadjuvare→stoshelp
•sMostscommonsadjuvantssforshumanssaresaluminumshydroxide,saluminumsphosphatesan
dscalciumsphosphate
•sOtherssincludesbacteriasandscholesterol
•sMineralsoilsemulsionssnormallysadjuvantssusedsinsanimalsstudies
•sAdjuvantsknownsassFreund'ssCompletesAdjuvantsconsistssofskilledstuberclesbacillisinswat
er-in-mineralsoilsemulsions
•sFreund'ssIncompletesAdjuvantsisswater-in-oilsemulsion
•sBothseffectivesinsstimulatingsimmunesresponsesbutscausesunacceptablessideseffectssinsh
umans
3sMechanismssAdjuvantssHelpsImmunesResponses-sans--
•sAdjuvantsshelpsimmunesresponsesbysformingsreservoirssofsantigenssandsprovidingssusta
inedsreleasesofsantigenssoverslongsperiod
•sAdjuvantssactsassnon-
specificsmediatorssofsimmunescellsfunctionsbysstimulatingsorsmodulatingsimmunescells
•sAdjuvantsscansservesassvehiclesstosdeliversantigenstosspleensand/orslymphsnodesswhere
simmunesresponsesissinitiated
Alzheimer'ssDiseases-sans--
•sVaccinesbeingstestedscontainsssmallsproteinscalledsBsamyloids(AB)
osThissproteinsformssabnormalsdepositssors"plaques"sinsthesbrainssofsindividualssw/sAlzhei
mer's
osIt'ssbelievedsthatsABsdepositionsCausesslosssofsmentalsfxnsbyskillingsbrainsneurons
osABsvaccinationsstimulatessimmunessystemstoscleansupsplaquessandspreventsfurthersABs
deposits
osPhasesIIsclinicalstrialswasshaltedsbecauses15sofs360spatientssdevelopedsseveresbrainsinfl
ammation
•sStudiessshowedsthatsABsdidsgeneratesdesiredsantibodysresponse
•sAcceptablesvaccinesmaysstillsbespossiblesbysmodifyingsepitopestosreducesinflammationse
ffects
Pneumococcals-sans--
•sInsOcts2006,sFDAsapprovedsusesofsPrevnarsforsimmunizationsofsinfantssandstoddlerssaga
instsotitissmediasmiddlesearsinfection
osPrevnarsisspneumococcalsseven-valentsconjugatesvaccine
•sFormulatedsw/ssterilessolutionsofssaccharidessconjugatedstosantigen
CORRECT ANSWERS
DrugsDiscoverys-sans--
•sUnlikessmallsmoleculesdrugss(pharmaceuticals),slargesmoleculesdrugss(biopharmaceutic
als)saresmainlysprotein-based
osThesesprotein-
basedsdrugssaressimilarstosnaturalsbiologicalscompoundssfoundsinshumansbodysorsthey'resf
ragmentssthatsmimicsactivespartsofsnaturalscompounds
DiscoverysofsPharmaceuticalss-sans--
commencessw/sscanningshundredssofscompounds,swhethersw/sactualsmaterialss(irrational
sapproach)sorsvirtualssimulationss(rationalsapproach)
•sPharmaceuticalssaresnewschemicalsentitiess(NCE)sandsaresproduceds(synthesized)sinsm
anufacturingsplantssusingstechniquessbasedsonschemicalsreactionssofsreactants
DiscoverysofsBiopharmaceuticalss-sans--
researchersshavestosexaminescompoundssw/inshumans
osEx.sHormonessorsothersbiologicalsresponsesmodifierssandshowstheysaffectsbiologicalspro
cesses
osInssomescases,sstudyspathogensssuchsassinfluenzasvirussorsbacteriastosderivesvaccines
osInsotherscases,sresearchersscopysthesesbiologicalsresponsesmodifierssandsusesthemsass
replacementstherapy
osProtein-
basedsdrugssaresmanufacturedsinsbiologicalssystems,ssuchsasslivingscells,sproducingsdesir
edsproteinsmoleculessinslargesreactionsvesselssorsbysextractionsfromsanimalsserum
osBecomingsincreasinglysimportant
•sMorespotentsandsspecific—
moressimilarstosproteinssw/insbodysthereforesmoreseffectivesinstreatingsoursdiseases
AreassofsBiopharmaceuticalss-sans--•sProphylactic→spreventivesassinsvaccines
•sTherapeutic→santibodies
•sReplacementstherapy→shormones,sgrowthsfactors
Biologicss-sans--FDAsdefinitionsis:
osBiologicalsproductssubjectstoslicensuresundersPublicsHealthsServicesActsissanysvirus,sthe
rapeuticsserum,stoxin,santitoxin,svaccine,sblood,sasbloodscomponentsorsderivative,sallerge
nicsproduce,sorsanalogoussproduct,sapplicablestosprevention,streatmentsorscuresofsdisease
ssorsinjuriesstoshumans.sBiologicalsproductssinclude,sbutsaresnotslimitedsto,sbacterialsandsvi
ralsvaccines,shumansbloodsandsplasmasandstheirsderivatives,sandscertainsproductssproduc
,edsbysbiotechnology,ssuchsassinterferonssandserythropoietins.sBiologicssencompasssman
ysdifferentsprotein-
basedsdrugs,sandsincludesbloodsproductsssuchsassclottingsfactorssextractedsfromsblood.
Vacciness-sans--
•sBasissofsvaccinationsissthatsadministeringssmallsquantitysofsasvaccines(antigensthatshassb
eenstreated)sstimulatessoursimmunessystemsandscausessantibodiesstosbessecretedstosreac
tsagainstsforeignsantigen
•sLatersinslife,swhenswesencountersanothersexposurestossamesantigen,soursimmunessyste
mswillsevokesasmemorysresponsesandsactivatesdefensesmechanismssbysgeneratingsantibo
diesstoscombatsinvadingsantigen
•sContainssantigenicscomponentssthatsaresobtainedsfromsorsderivedsfromspathogen
osIncludesmainlysviruses,sbacteria,sparasitessandsfungi
osResearchshassshownsthatspartsofspathogensthatscausessdiseases(virulence)scansbesdec
oupledsfromsprotectivesparts(immunity)
•sDevelopmentsfocusessonsmeansstosreducesvirulencesfactorswhilesretainingsimmunityssti
mulation
•sOralsorsparenteral
VaccinesPreparationss-sans--AttenuatedsVaccines
KilledsorsInactivatedsVaccines
Toxoids
AttenuatedsVacciness-sans--
•sVirulencesofspathogensthatscansbesreducedsinsnumbersofsways
•sByschemicalstreatment,sbystemperaturesadaptation,sorsbysgrowingspathogensinsspecifieds
othersthansnaturalshosts(passaging)
•sAdvantagessareslowscostspreparation,selicitsdesiredsimmunologicalsresponse,sandsnorm
allyssinglesdosesisssufficient
•sDisadvantagessarespotentialstosrevertstosvirulencesandslimitedsshelfslife
KilledsorsInactivatedsVacciness-sans--
•sChemicalsandstemperaturestreatmentsaresnormallysusedstoskillsorsinactivatespathogen
•sFormaldehydestreatmentsmostscommonsmethod
•sOtherschemicalssusedsaresphenolsandsacetone
•sAnothersmethodsisstosirradiatespathogenstosrendersitsinactive
•sAdvantagessaresnon-reversalstosvirulencesandsrelativelysstablesshelfslife
•sDisadvantagessareshigherscostsofsproduction,smorescontrolsissrequiredsforsproductionstos
ensuresreliablesprocessessforscompletesinactivationsandstheresisspossibilitysofsreducedsim
munologicalsresponsesduestostreatmentsprocessesssosmultiplesboostersvaccinationssmays
besrequired
Toxoidss-sans--•sDerivedsfromstoxinsssecretedsbyspathogen
•sAdvantagessandsdisadvantagesssimilarstoskilledsorsinactivatedsvaccines(advantages:sno
n-
reversalstosvirulencesandsrelativelysstablesshelfslife;sdisadvantages:shigherscostsofsproduct
,ion,smorescontrolsissrequiredsforsproductionstosensuresreliablesprocessessforscompletesina
ctivationsandstheresisspossiblitysofsreducedsimmunologicalsresponsesduestostreatmentspro
cessesssosmultiplesboostersvaccinationssmaysbesrequired)
NewsVacciness-sans--
•sAdvancessinsgenomics,smolecularsbiologysandsrecombinantstechnologyshassprovidedsne
wsdirectionssforsdiscovery,sdevelopmentsandsmanufacturesofsvaccines
•sCurrentsapproachsissminimalistsstrategystosdecouplesvirulencesandsimmunitysfunctions
•sAimsisstosusesonlysimmunityspartstosconfersprotection,ssosvaccinesisssafestosbesadminister
ed
•sApproachscansbesdividedsintossubunit,svector-based,sDNAsandspeptidesvaccines
SubunitsVacciness-sans--•sUsesonlyspartsofsbacteriasorsvirussinsteadsofsentirespathogen
•sPartsissderivedsfromsoutsidesenvelopesproteinsofspathogen
•sRequiressknowledgesofsgenomessequencesofspathogensbysidentifyingsopensreadingsfra
mess(ORF)sthatspotentiallysencodesnovelsantigenicssurfacesproteinssknownsassepitopes,s
whichsbindstosantibodies
•sWhensidentified,sORFssaresclonedstosexpresssproteinsepitopessusingsself-
replicatingsplasmids
•sBindingspropertiessofsepitopesscansbesstudiedsusingsenzymeslinkedsimmunosorbentsass
ays(ELISA)sorsfluorescentsactivatedscellssorters(FACS)
•sLeadingscandidatessofsepitopessaresinjectedsintosanimalsstosdetermineswhetherstheyselic
itsanysantibodysresponse
osThosesthatsworksaresselectedsandsoptimizedstosbecomesvaccinescandidatessw/sfurtherst
estssbeforeshumansclinicalstrials
osAlsosworkingsonsmultiplesepitopessubunitsvaccinesswhichscansprovidesdifferentsantigenic
sbindingssites
Vector-basedsVacciness-sans--
•sVirusessandsbacteriasaresdetoxifiedsandsusedsassvehiclesstoscarrysvaccines
•sSubunitsvaccinessaresbeingsdeliveredsbyscarriersvehiclesstoselicitsimmunesresponse
•sMultiplestypessofsenvelopesproteinsscansbesdeliveredsw/sthissmethod
•sClinicalstrialssw/sthisstypesofsvector-basedsvaccinessaresbeingsinvestigated
DNAsVacciness-sans--•sAkasnucleicsvaccinessorsgeneticsimmunization
•sHosts(patient)sissdirectlysinjectedsw/sselectedsviralsgenesswhichscontainsengineeredsDNA
ssequencessthatscodesforsantigens
•sHostssownscellsstakesupsthesesgenessandsexpresssantigensswhichsaresthenspresentedsto
simmunescellssandsactivatesimmunesresponse
PeptidesVacciness-sans--•sChemicallyssynthesizedsandsnormallysconsistsofs8-
24saminosacids
•sRelativelyssmall
•sAkaspeptidomimeticsvaccinessasstheysmimicsepitopes
•sComplexsstructuressofscyclicscomponents,sbranchedschainsorsothersconfigurationsscansb
esbuiltsintospeptideschain
, •sTheyspossesssconformationsssimilarstosepitopessandscansbesrecognizedsbysimmunescell
s
•sAnsinssilicosvaccinesdesignsapproachshassbeensusedstosfindspotentialsepitopes
•sCriticalsaspectsofspeptidesvaccinessisstosproduces3Dsstructuresssimilarstosnativesepitopes
sofspathogen
Adjuvants-sans--
•sVaccinessformulatedsw/scertainssubstancesstosenhancesimmunesresponse
•sLatinsadjuvare→stoshelp
•sMostscommonsadjuvantssforshumanssaresaluminumshydroxide,saluminumsphosphatesan
dscalciumsphosphate
•sOtherssincludesbacteriasandscholesterol
•sMineralsoilsemulsionssnormallysadjuvantssusedsinsanimalsstudies
•sAdjuvantsknownsassFreund'ssCompletesAdjuvantsconsistssofskilledstuberclesbacillisinswat
er-in-mineralsoilsemulsions
•sFreund'ssIncompletesAdjuvantsisswater-in-oilsemulsion
•sBothseffectivesinsstimulatingsimmunesresponsesbutscausesunacceptablessideseffectssinsh
umans
3sMechanismssAdjuvantssHelpsImmunesResponses-sans--
•sAdjuvantsshelpsimmunesresponsesbysformingsreservoirssofsantigenssandsprovidingssusta
inedsreleasesofsantigenssoverslongsperiod
•sAdjuvantssactsassnon-
specificsmediatorssofsimmunescellsfunctionsbysstimulatingsorsmodulatingsimmunescells
•sAdjuvantsscansservesassvehiclesstosdeliversantigenstosspleensand/orslymphsnodesswhere
simmunesresponsesissinitiated
Alzheimer'ssDiseases-sans--
•sVaccinesbeingstestedscontainsssmallsproteinscalledsBsamyloids(AB)
osThissproteinsformssabnormalsdepositssors"plaques"sinsthesbrainssofsindividualssw/sAlzhei
mer's
osIt'ssbelievedsthatsABsdepositionsCausesslosssofsmentalsfxnsbyskillingsbrainsneurons
osABsvaccinationsstimulatessimmunessystemstoscleansupsplaquessandspreventsfurthersABs
deposits
osPhasesIIsclinicalstrialswasshaltedsbecauses15sofs360spatientssdevelopedsseveresbrainsinfl
ammation
•sStudiessshowedsthatsABsdidsgeneratesdesiredsantibodysresponse
•sAcceptablesvaccinesmaysstillsbespossiblesbysmodifyingsepitopestosreducesinflammationse
ffects
Pneumococcals-sans--
•sInsOcts2006,sFDAsapprovedsusesofsPrevnarsforsimmunizationsofsinfantssandstoddlerssaga
instsotitissmediasmiddlesearsinfection
osPrevnarsisspneumococcalsseven-valentsconjugatesvaccine
•sFormulatedsw/ssterilessolutionsofssaccharidessconjugatedstosantigen
