Anatomy and Physiology Lab Exa
vg vg vg vg
m 1 vg
Studyvgonlinevgatvghttps://quizlet.com/_ua65q
BCMAS EXAM
Mostvgcommonlyvgusedvgstudyvgdesign:vg-vganswer--parallel
UndervgwhatvgconditionsvgcanvgavgpharmavgcompanyvgprovidevgfinancialvgsupportvgforvgconferencesvgandvgCME?vg-
vganswer--Thevggrants/contributionsvgarevgseparatevgfromvgothervgcompanyvgfunds
Thevgcompanyvghasvghadvgnovgcontrolvgovervgthevgselectionvgofvgcontent,vgfaculty,vgorvgvenue
NotvgrequiredvgbyvgADRvgreporting:vg-vganswer--carefulvgselectionvgofvgclinicalvgtrialvgparticipants
Required:
-recognitionvgofvgevents
-safetyvgsignalsvgarevgidentifiedvgagainstvgavgbackgroundvgofvgevents
-accuratevgreporting
Individualvgboardvgmembersvgarevgknownvgas:vg-vganswer--advisors
invgvitrovgdiagnosticvgtestvg-vgexamplevg-vganswer--microbiologyvgculture
invgvitrovgversusvginvgvivovg-vganswer--invgvitrovgdescribesvgsomethingvg"invgglass"vgsuchvgasvgavgtestvgtubevgorvgpetrivgdish
invgvivovgisvg"withinvgavglivingvgorganism"
FundamentalvgrequirementvgforvgongoingvgriskvgevaluationsvgofvgREMS:vg-vganswer--timelyvgdatavgcollection
Bestvgpracticevgandvgethicalvgstandardsvgforvgreportingvgresearchvgpublishedvginvgmedicalvgjournalsvg-vganswer--ICMJE
T/
F:vgElementsvgtovgAssurevgSafevgUsevg(ETASU)vgarevgrequiredvgmedicalvginterventionsvgtakenvgbyvgHCPsvgpriorvgtovgusi
vgthevgdrug.vg-vganswer--True
Combinationvgproductvgapplicant(s)vg-vganswer--
Thevgcompanyvgthatvgholdsvgthevgapplicationvgforvgthevgcombinationvgproductvgasvgavgwhole
T/F:vgSeverevgbirthvgdefectsvgisvgnotvganvgFDAvgmandatedvgREMS.vg-vganswer--False
Exportvgchallengevgofvgavgmedicalvgdevicevgcompany:vg-vganswer--Violationvgofvgintellectualvgpropertyvgrights
PurposesvgofvgIISvg-vganswer--developvgandvgsupportvgnewvgindication
enhancevgptvgbenefits/healthvgoutcomes
improvevgavailablevgproductvgsafetyvgandvg
NOTvgavgpurposevg=vgsupportvgptvgcommunity
Goalsvgofvgpharmacogenomicsvg-vganswer--Individualizevgtherapiesvgbasedvgonvggeneticvgdifferences
Predictvgindividualvgresponsesvgtovgavgdrugvgtovgdecreasevgadversevgdrugvgreactions
Improvevgthevgoverallvgefficacyvgandvgsafetyvgofvgdrugs
1vg/
vg22
, Anatomy and Physiology Lab Exa
vg vg vg vg
m 1 vg
Studyvgonlinevgatvghttps://quizlet.com/_ua65q
NOTvgavggoalvg=vgdecreasevgmedicationvgadherence
FDAvgclearancevgforvgmedicalvgdevicesvg-vganswer--
Mayvgbevggivenvgforvgdevicesvgwithvgsubstantialvgequivalencevgtovgavgknownvgpredicatevgdevice
AllowsvgthevgdevicevgtovgbevgmarketedvgandvgsoldvgoncevgavgPre-MarketvgNotificationvghasvgbeenvgsubmitted
Mayvgbevgissuedvgifvgthevgdevicevgexistedvginvgthevgmarketvgpriorvgtovg1976
EBMvgdatabasesvg-vganswer--DynaMed
CochranevgLibrary
T/F:vgPresentationvgskillsvgarevgnotvgessentialvgforvgmaintainingvgavgpositionvgwithvgMA.vg-vganswer--False
WhatvgwouldvgcausevgthevgFDAvgtovgrequirevgpost-
marketingvgstudiesvgorvgclinicalvgtrialsvgatvgthevgtimevgofvgapprovalvgorvgafterwardsvgforvgavgnewvgproduct?vg-vganswer--
IfvgthevgFDAvgbecomesvgawarevgofvgnewvgsafetyvginformationvgfromvgSADRvgreporting.
Whenvgfirstvgworkingvgonvgavgpublication,vgwhatvgshouldvgauthorsvgdovgtovgidentifyvgtheirvgrights,vgroles,vgandvgresponsibi
es?vg-vganswer--Documentvgthevgagreement
Thevgprocessvgofvginternalvgcooperation,vgcoordination,vgandvgcommonvgstandardsvgacrossvgthevgglobalvgpharmaceutic
gindustryvgisvgreferredvgtovgas:vg-vganswer--Harmonization
5-stepvgprocessvgtovgrespondvgtovgavgmedicalvginformationvgquestionvg-vganswer--1)vgDeterminevgwhovgthevgaudiencevgis
2)vgUnderstandvgwhatvgthevgprimaryvgquestionvgis
3)vgDevelopvganvgappropriatevgresearchvgstrategy
4)vgChoosevgthevgbestvgsource
5)vgAssessvgthevginformationvgsourcevgandvganswervgthevgquestion
T/f:vgSRDsvgarevgpreparedvgonlyvgforvgHCPsvginvgresponsevgtovgquestionsvgaboutvgproduct(s).vg-vganswer--False
Whovgisvgrequiredvgtovgsubmitvgavgperiodicvgsafetyvgupdatevgreport?vg-vganswer--
Marketingvgauthorizationvgholdersvg(MAHs)vgaccordingvgtovgthevgdatavgpointsvgoutlinedvginvgthevgEURDvglist.
T/F:vgSurveysvgarevgclassifiedvgasvgcross-sectionalvgstudies.vg-vganswer--True
MedicalvgDevicevgUservgFeesvgAmendmentvgofvg2012vg-vganswer--AllowsvgthevgFDAvgtovgcollectvguservgfeesvgforvgpre-
marketvgapprovalsvgtovgimprovevgthevgoverallvgreviewvgprocess
T/F:vgAnvgabbreviatedvgnewvgdrugvgapplicationvg(ANDA)vgisvgsubmittedvgtovgthevgFDAvgforvggenericvgdrugs.vg-vganswer--
True
Thevgriskvgassociatedvgwithvgthisvgtypevgofvgdrugvgmayvgnotvgbevgwellvgunderstood.vg-vganswer--Newvgdrugvgsubstance
AmbervgisvganvgMSLvgandvgreceivesvgavgquestionvgfromvgavgphysicianvgaboutvgavgmedicationvgindicationvgthatvgisvgnotvgFD
gapproved.vgWhichvgofvgthevgfollowingvgisvgtrue?vg-vganswer--Thisvgisvganvgunsolicitedvgrequest.
Thisvginformationvgisvgoff-label.
2vg/
vg22
, Anatomy and Physiology Lab Exa
vg vg vg vg
m 1
vg
Studyvgonline
AvgPharmavgcompany vgat
vgis vghttps://quizlet.com/_ua65q
vglooking vgtovgbeginvgthevgdevelopment vgofvgavgnewvgdrug.vgWhyvgwouldvgthevgcompanyvgconsu
anvgadvisoryvgboard?vg-vganswer--Tovgprovidevgtheirvgopinionvgonvgthevgresearchvgandvgdevelopmentvgofvgthevgdrug
T/F:vgUndervgthevgsecond-
tiervgregulations,vginvg21vgCFRvgPartvg56vg(InstitutionalvgReviewvgBoardvg(IRB))vgsubpartvgB,vgtherevgneedsvgtovgbevgavgm
mumvgofvg2vgmembersvginvgthevgIRB.vg-vganswer--False
WhichvgarevgconsideredvgkeyvgitemsvgthevgFDAvgwillvgcontemplatevgwhenvgdecidingvgonvgwhethervgREMSvgisvgneeded?v
vganswer--Seriousnessvgofvgthevgdisease
Seriousnessvgofvgsidevgeffects
Benefitvgofvgthevgdrug
Invgresearchvgwhichvgofvgthevgtermsvgbelowvgdescribesvgavgdistortionvgcausedvgbyvgothervgvariablesvgtovgbothvgexposurev
ndvgoutcome?vg-vganswer--confounding
T/
F:vgMedicalvgwritersvgshouldvgavoidvgaddressingvgthevgpublic'svgquestionsvgtovgpreventvgthevgspreadvgofvghealthvgmisinfo
ation.vg-vganswer--False
Whatvgarevgsomevgofvgthevgwaysvgthatvgcompaniesvgcanvgbenefitvgfromvgnon-mandatedvgPost-Marketingvgstudies?vg-
vganswer--Detectvganyvgcost-benefitsvgassociatedvgwithvgthevgdrugs
Comparevgavgdrugvgwithvgothervgcurrentlyvgavailablevgmedicationsvginvgthevgsamevgclass
Detectvgothervgusesvgofvgthevgdrugs
Approximatelyvghowvgmanyvgslidesvgshouldvgavg15vgminutevgpresentationvginclude?vg-vganswer--7-8
Dr.vgSimpson,vgavgneurologist,vgoccasionallyvgparticipatesvgonvganvgadvisoryvgboardvgforvgLightningvgPharmaceuticals.v
r.vgSimpsonvghasvgalsovgjustvgbecomevgavgmembervgofvgavgnationalvgcommitteevgthatvgmakesvgrecommendationsvgforvgcl
calvgguidelinesvgandvgformularyvgdecisions.vgIsvgDr.vgSimpsonvgrequiredvgtovgdisclosevghervgrelationshipvgwithvgLightning
Pharmaceuticalsvgtovgthevgnationalvgcommitteevgshevgisvgavgmembervgof?vg-vganswer--
Yes,vgitvgwouldvgbevgunethicalvgandvgpotentiallyvgavgconflictvgofvginterestvgifvgshevgdoesvgnotvgdisclosevgthevgrelationship.
Whichvgstatementvgisvgnotvgtruevgaboutvgpromotionalvgmaterials?
A)vgPromotionalvgmaterialsvgmustvgpresentvganvgunbiasedvgpicturevgofvgthevgdrug,vgincludingvgitsvgrisksvgandvgbenefits
B)vgAllvgMSLsvgshouldvgoffervgthevgsamevgpromotionalvgmaterialsvgprovidedvgbyvgthevgcompanyvgandvgnotvg"makevgtheirv
wn"
C)vgPromotionalvgmaterialsvgcanvgincludevgoff-labelvgdrugvginformation
D)vgPromotionalvgmaterialsvgmustvgadherevgtovgFDAvgrequirementsvgandvglabelvginformationvgonlyvg-vganswer--
C)vgPromotionalvgmaterialsvgcanvgincludevgoff-labelvgdrugvginformation
T/
F:vgThevgregulatoryvgrequirementsvgforvgdrugvgproductsvgincludevgmuchvgtightervgcontrolsvgovervgthevgmanufacturingvgpr
essvgthanvgforvgmedicalvgdevices.vg-vganswer--True
"ThevgstudyvgofvgvariationsvginvgDNAvgandvgRNAvgcharacteristicsvgasvgrelatedvgtovgdrugvgresponse"vg-vganswer--
Pharmacogenomics
3vg/
vg22
vg vg vg vg
m 1 vg
Studyvgonlinevgatvghttps://quizlet.com/_ua65q
BCMAS EXAM
Mostvgcommonlyvgusedvgstudyvgdesign:vg-vganswer--parallel
UndervgwhatvgconditionsvgcanvgavgpharmavgcompanyvgprovidevgfinancialvgsupportvgforvgconferencesvgandvgCME?vg-
vganswer--Thevggrants/contributionsvgarevgseparatevgfromvgothervgcompanyvgfunds
Thevgcompanyvghasvghadvgnovgcontrolvgovervgthevgselectionvgofvgcontent,vgfaculty,vgorvgvenue
NotvgrequiredvgbyvgADRvgreporting:vg-vganswer--carefulvgselectionvgofvgclinicalvgtrialvgparticipants
Required:
-recognitionvgofvgevents
-safetyvgsignalsvgarevgidentifiedvgagainstvgavgbackgroundvgofvgevents
-accuratevgreporting
Individualvgboardvgmembersvgarevgknownvgas:vg-vganswer--advisors
invgvitrovgdiagnosticvgtestvg-vgexamplevg-vganswer--microbiologyvgculture
invgvitrovgversusvginvgvivovg-vganswer--invgvitrovgdescribesvgsomethingvg"invgglass"vgsuchvgasvgavgtestvgtubevgorvgpetrivgdish
invgvivovgisvg"withinvgavglivingvgorganism"
FundamentalvgrequirementvgforvgongoingvgriskvgevaluationsvgofvgREMS:vg-vganswer--timelyvgdatavgcollection
Bestvgpracticevgandvgethicalvgstandardsvgforvgreportingvgresearchvgpublishedvginvgmedicalvgjournalsvg-vganswer--ICMJE
T/
F:vgElementsvgtovgAssurevgSafevgUsevg(ETASU)vgarevgrequiredvgmedicalvginterventionsvgtakenvgbyvgHCPsvgpriorvgtovgusi
vgthevgdrug.vg-vganswer--True
Combinationvgproductvgapplicant(s)vg-vganswer--
Thevgcompanyvgthatvgholdsvgthevgapplicationvgforvgthevgcombinationvgproductvgasvgavgwhole
T/F:vgSeverevgbirthvgdefectsvgisvgnotvganvgFDAvgmandatedvgREMS.vg-vganswer--False
Exportvgchallengevgofvgavgmedicalvgdevicevgcompany:vg-vganswer--Violationvgofvgintellectualvgpropertyvgrights
PurposesvgofvgIISvg-vganswer--developvgandvgsupportvgnewvgindication
enhancevgptvgbenefits/healthvgoutcomes
improvevgavailablevgproductvgsafetyvgandvg
NOTvgavgpurposevg=vgsupportvgptvgcommunity
Goalsvgofvgpharmacogenomicsvg-vganswer--Individualizevgtherapiesvgbasedvgonvggeneticvgdifferences
Predictvgindividualvgresponsesvgtovgavgdrugvgtovgdecreasevgadversevgdrugvgreactions
Improvevgthevgoverallvgefficacyvgandvgsafetyvgofvgdrugs
1vg/
vg22
, Anatomy and Physiology Lab Exa
vg vg vg vg
m 1 vg
Studyvgonlinevgatvghttps://quizlet.com/_ua65q
NOTvgavggoalvg=vgdecreasevgmedicationvgadherence
FDAvgclearancevgforvgmedicalvgdevicesvg-vganswer--
Mayvgbevggivenvgforvgdevicesvgwithvgsubstantialvgequivalencevgtovgavgknownvgpredicatevgdevice
AllowsvgthevgdevicevgtovgbevgmarketedvgandvgsoldvgoncevgavgPre-MarketvgNotificationvghasvgbeenvgsubmitted
Mayvgbevgissuedvgifvgthevgdevicevgexistedvginvgthevgmarketvgpriorvgtovg1976
EBMvgdatabasesvg-vganswer--DynaMed
CochranevgLibrary
T/F:vgPresentationvgskillsvgarevgnotvgessentialvgforvgmaintainingvgavgpositionvgwithvgMA.vg-vganswer--False
WhatvgwouldvgcausevgthevgFDAvgtovgrequirevgpost-
marketingvgstudiesvgorvgclinicalvgtrialsvgatvgthevgtimevgofvgapprovalvgorvgafterwardsvgforvgavgnewvgproduct?vg-vganswer--
IfvgthevgFDAvgbecomesvgawarevgofvgnewvgsafetyvginformationvgfromvgSADRvgreporting.
Whenvgfirstvgworkingvgonvgavgpublication,vgwhatvgshouldvgauthorsvgdovgtovgidentifyvgtheirvgrights,vgroles,vgandvgresponsibi
es?vg-vganswer--Documentvgthevgagreement
Thevgprocessvgofvginternalvgcooperation,vgcoordination,vgandvgcommonvgstandardsvgacrossvgthevgglobalvgpharmaceutic
gindustryvgisvgreferredvgtovgas:vg-vganswer--Harmonization
5-stepvgprocessvgtovgrespondvgtovgavgmedicalvginformationvgquestionvg-vganswer--1)vgDeterminevgwhovgthevgaudiencevgis
2)vgUnderstandvgwhatvgthevgprimaryvgquestionvgis
3)vgDevelopvganvgappropriatevgresearchvgstrategy
4)vgChoosevgthevgbestvgsource
5)vgAssessvgthevginformationvgsourcevgandvganswervgthevgquestion
T/f:vgSRDsvgarevgpreparedvgonlyvgforvgHCPsvginvgresponsevgtovgquestionsvgaboutvgproduct(s).vg-vganswer--False
Whovgisvgrequiredvgtovgsubmitvgavgperiodicvgsafetyvgupdatevgreport?vg-vganswer--
Marketingvgauthorizationvgholdersvg(MAHs)vgaccordingvgtovgthevgdatavgpointsvgoutlinedvginvgthevgEURDvglist.
T/F:vgSurveysvgarevgclassifiedvgasvgcross-sectionalvgstudies.vg-vganswer--True
MedicalvgDevicevgUservgFeesvgAmendmentvgofvg2012vg-vganswer--AllowsvgthevgFDAvgtovgcollectvguservgfeesvgforvgpre-
marketvgapprovalsvgtovgimprovevgthevgoverallvgreviewvgprocess
T/F:vgAnvgabbreviatedvgnewvgdrugvgapplicationvg(ANDA)vgisvgsubmittedvgtovgthevgFDAvgforvggenericvgdrugs.vg-vganswer--
True
Thevgriskvgassociatedvgwithvgthisvgtypevgofvgdrugvgmayvgnotvgbevgwellvgunderstood.vg-vganswer--Newvgdrugvgsubstance
AmbervgisvganvgMSLvgandvgreceivesvgavgquestionvgfromvgavgphysicianvgaboutvgavgmedicationvgindicationvgthatvgisvgnotvgFD
gapproved.vgWhichvgofvgthevgfollowingvgisvgtrue?vg-vganswer--Thisvgisvganvgunsolicitedvgrequest.
Thisvginformationvgisvgoff-label.
2vg/
vg22
, Anatomy and Physiology Lab Exa
vg vg vg vg
m 1
vg
Studyvgonline
AvgPharmavgcompany vgat
vgis vghttps://quizlet.com/_ua65q
vglooking vgtovgbeginvgthevgdevelopment vgofvgavgnewvgdrug.vgWhyvgwouldvgthevgcompanyvgconsu
anvgadvisoryvgboard?vg-vganswer--Tovgprovidevgtheirvgopinionvgonvgthevgresearchvgandvgdevelopmentvgofvgthevgdrug
T/F:vgUndervgthevgsecond-
tiervgregulations,vginvg21vgCFRvgPartvg56vg(InstitutionalvgReviewvgBoardvg(IRB))vgsubpartvgB,vgtherevgneedsvgtovgbevgavgm
mumvgofvg2vgmembersvginvgthevgIRB.vg-vganswer--False
WhichvgarevgconsideredvgkeyvgitemsvgthevgFDAvgwillvgcontemplatevgwhenvgdecidingvgonvgwhethervgREMSvgisvgneeded?v
vganswer--Seriousnessvgofvgthevgdisease
Seriousnessvgofvgsidevgeffects
Benefitvgofvgthevgdrug
Invgresearchvgwhichvgofvgthevgtermsvgbelowvgdescribesvgavgdistortionvgcausedvgbyvgothervgvariablesvgtovgbothvgexposurev
ndvgoutcome?vg-vganswer--confounding
T/
F:vgMedicalvgwritersvgshouldvgavoidvgaddressingvgthevgpublic'svgquestionsvgtovgpreventvgthevgspreadvgofvghealthvgmisinfo
ation.vg-vganswer--False
Whatvgarevgsomevgofvgthevgwaysvgthatvgcompaniesvgcanvgbenefitvgfromvgnon-mandatedvgPost-Marketingvgstudies?vg-
vganswer--Detectvganyvgcost-benefitsvgassociatedvgwithvgthevgdrugs
Comparevgavgdrugvgwithvgothervgcurrentlyvgavailablevgmedicationsvginvgthevgsamevgclass
Detectvgothervgusesvgofvgthevgdrugs
Approximatelyvghowvgmanyvgslidesvgshouldvgavg15vgminutevgpresentationvginclude?vg-vganswer--7-8
Dr.vgSimpson,vgavgneurologist,vgoccasionallyvgparticipatesvgonvganvgadvisoryvgboardvgforvgLightningvgPharmaceuticals.v
r.vgSimpsonvghasvgalsovgjustvgbecomevgavgmembervgofvgavgnationalvgcommitteevgthatvgmakesvgrecommendationsvgforvgcl
calvgguidelinesvgandvgformularyvgdecisions.vgIsvgDr.vgSimpsonvgrequiredvgtovgdisclosevghervgrelationshipvgwithvgLightning
Pharmaceuticalsvgtovgthevgnationalvgcommitteevgshevgisvgavgmembervgof?vg-vganswer--
Yes,vgitvgwouldvgbevgunethicalvgandvgpotentiallyvgavgconflictvgofvginterestvgifvgshevgdoesvgnotvgdisclosevgthevgrelationship.
Whichvgstatementvgisvgnotvgtruevgaboutvgpromotionalvgmaterials?
A)vgPromotionalvgmaterialsvgmustvgpresentvganvgunbiasedvgpicturevgofvgthevgdrug,vgincludingvgitsvgrisksvgandvgbenefits
B)vgAllvgMSLsvgshouldvgoffervgthevgsamevgpromotionalvgmaterialsvgprovidedvgbyvgthevgcompanyvgandvgnotvg"makevgtheirv
wn"
C)vgPromotionalvgmaterialsvgcanvgincludevgoff-labelvgdrugvginformation
D)vgPromotionalvgmaterialsvgmustvgadherevgtovgFDAvgrequirementsvgandvglabelvginformationvgonlyvg-vganswer--
C)vgPromotionalvgmaterialsvgcanvgincludevgoff-labelvgdrugvginformation
T/
F:vgThevgregulatoryvgrequirementsvgforvgdrugvgproductsvgincludevgmuchvgtightervgcontrolsvgovervgthevgmanufacturingvgpr
essvgthanvgforvgmedicalvgdevices.vg-vganswer--True
"ThevgstudyvgofvgvariationsvginvgDNAvgandvgRNAvgcharacteristicsvgasvgrelatedvgtovgdrugvgresponse"vg-vganswer--
Pharmacogenomics
3vg/
vg22
