NAPSRX CNPR EXAM (REVISED 18TH
EDITION)
whatvgdoesvgavgSTATvgordervgmean?vg-vganswer--
avgdrugvgneededvgimmediatelyvgandvggivenvgonlyvgonce
whatvginformationvgdoesvgthevgoverdosagevgsectionvgofvgthevglabelingvgprovide?vg-
vganswer--signs,vgsymptomsvgandvgtreatmentvgofvgacutevgoverdoses
typesvgofvgdrug-drugvginteractions:vg-vganswer--
duplication,vgoppositionvg(antagonism)vgandvgalterationvg(p.51)
tolerancevgvsvgresistancevg-vganswer--
tolerancevgisvgthevgdiminishedvgresponsevgtovgavgdrug;vgresistancevgisvgthevgcellsvgabilityvgt
ovgresistvgthevgeffectsvgofvgthevgdrugvgonvgthem.
abbreviatedvgnewvgdrugvgapplicationvg(ANDA)vg-vganswer--
thevgprocessvgbyvgwhichvgapplicantsvgmustvgscientificallyvgdemonstratevgtovgthevgFDAvgtha
tvgtheirvggenericvgproductvgisvgbioequivalentvgtovgorvgperformsvginvgthevgsamevgwayvgasvgthe
vginnovatorvgdrug,vgnovgduplicatevgtestingvg(p.vg75)
thevgHatch-WaxmanvgActvgofvg1984vg-vganswer---
A.K.A.vgDrugvgPricevgCompetitionvgandvgPatentvgRestorationvgAct
-
madevgitvgeasiervgtovgbringvggenericvgdrugsvgtovgthevgmarketvgbyvgrequiringvgthevgFDAvgtovgo
nlyvglookvgatvgbioavailabilityvgstudiesvginvgordervgtovgapprovevganvgANDA.
-gavevgprotectionvgtovgthevgresearchvgbasedvgmanufacturersvgbyvgprovidingvgavg30-
monthvgautomaticvgcoolingvgoffvgperiodvgoncevganvgANDAvgisvgchallengedvgforvgpatentvginfr
ingementvg(p.vg75)
fourvgbasicvgtransportvgmechanismsvg-vganswer--
passivevgdiffusion,vgfacilitatedvgdiffusion,vgactivevgtransport,vgandvgpinocytosisvg(p.vg95)
potencyvgvsvgefficacyvg-vganswer--
potency:vgamountvgofvgdrugvgnecessaryvgtovgproducevgdesiredvgeffect
efficacy:vgmagnitudevgofvgmaximalvgresponsevgthatvgcanvgbevgreceivedvgfromvgavgdrug
*efficacyvgisvgalmostvgalwaysvgmorevgimportantvgthatvgpotency*vg(p.vg106)
thevgfourvgphasesvgofvgclinicalvgtrialsvg-vganswer--phasesvgI-IVvg(P.vg124-126)
KeyvgPartsvgOfvgAvgClinicalvgPapervg(5)vg-vganswer--
Abstract,vgIntroduction,vgmethods,vgresults,vgdiscussion/conclusionsvg(p.vg128-129)
reliabilityvgvsvgvalidityvg-vganswer--reliabilityvg=vgconsistencyvgandvgvalidityvg=vgaccuracy
(p.vg138;vg143)
EDITION)
whatvgdoesvgavgSTATvgordervgmean?vg-vganswer--
avgdrugvgneededvgimmediatelyvgandvggivenvgonlyvgonce
whatvginformationvgdoesvgthevgoverdosagevgsectionvgofvgthevglabelingvgprovide?vg-
vganswer--signs,vgsymptomsvgandvgtreatmentvgofvgacutevgoverdoses
typesvgofvgdrug-drugvginteractions:vg-vganswer--
duplication,vgoppositionvg(antagonism)vgandvgalterationvg(p.51)
tolerancevgvsvgresistancevg-vganswer--
tolerancevgisvgthevgdiminishedvgresponsevgtovgavgdrug;vgresistancevgisvgthevgcellsvgabilityvgt
ovgresistvgthevgeffectsvgofvgthevgdrugvgonvgthem.
abbreviatedvgnewvgdrugvgapplicationvg(ANDA)vg-vganswer--
thevgprocessvgbyvgwhichvgapplicantsvgmustvgscientificallyvgdemonstratevgtovgthevgFDAvgtha
tvgtheirvggenericvgproductvgisvgbioequivalentvgtovgorvgperformsvginvgthevgsamevgwayvgasvgthe
vginnovatorvgdrug,vgnovgduplicatevgtestingvg(p.vg75)
thevgHatch-WaxmanvgActvgofvg1984vg-vganswer---
A.K.A.vgDrugvgPricevgCompetitionvgandvgPatentvgRestorationvgAct
-
madevgitvgeasiervgtovgbringvggenericvgdrugsvgtovgthevgmarketvgbyvgrequiringvgthevgFDAvgtovgo
nlyvglookvgatvgbioavailabilityvgstudiesvginvgordervgtovgapprovevganvgANDA.
-gavevgprotectionvgtovgthevgresearchvgbasedvgmanufacturersvgbyvgprovidingvgavg30-
monthvgautomaticvgcoolingvgoffvgperiodvgoncevganvgANDAvgisvgchallengedvgforvgpatentvginfr
ingementvg(p.vg75)
fourvgbasicvgtransportvgmechanismsvg-vganswer--
passivevgdiffusion,vgfacilitatedvgdiffusion,vgactivevgtransport,vgandvgpinocytosisvg(p.vg95)
potencyvgvsvgefficacyvg-vganswer--
potency:vgamountvgofvgdrugvgnecessaryvgtovgproducevgdesiredvgeffect
efficacy:vgmagnitudevgofvgmaximalvgresponsevgthatvgcanvgbevgreceivedvgfromvgavgdrug
*efficacyvgisvgalmostvgalwaysvgmorevgimportantvgthatvgpotency*vg(p.vg106)
thevgfourvgphasesvgofvgclinicalvgtrialsvg-vganswer--phasesvgI-IVvg(P.vg124-126)
KeyvgPartsvgOfvgAvgClinicalvgPapervg(5)vg-vganswer--
Abstract,vgIntroduction,vgmethods,vgresults,vgdiscussion/conclusionsvg(p.vg128-129)
reliabilityvgvsvgvalidityvg-vganswer--reliabilityvg=vgconsistencyvgandvgvalidityvg=vgaccuracy
(p.vg138;vg143)
