PHM 351 Exam 1 With Questions And
Correct Answers
patent cmedicines c- cCORRECT cANS✔✔products cthat cwere csold, cmost coften cin cthe
c19th ccentury, cas cmedicines cthat cwould ccure ca chost cof cillnesses cand cdiseases
medicine cwith cpoisonous csubstances cmust cbe clabeled cas cpoisonous con cbottles c-
cCORRECT cANS✔✔the cfirst cdrug cregulations cin cthe cmid-1800s crequired cthat...
Pure cFood cand cDrug cAct c- cCORRECT cANS✔✔Drug cregulation cin c1906 cthat
crequired cmedicine clabels cbe ctruthful cand clist cany cingredients cthat cwere ca cpart cof ca
clist cof c10 caddictive cor cdangerous csubstances. cEnforced cby cthe cUSDA cBureau cof
cChemistry
Harrison cNarcotics cAct c- cCORRECT cANS✔✔1914, cestablished cfee cto clicense
cnarcotics cfor cmanufacturers cand cprescribers cof cnarcotics. cPatent cmedicine cwas
cexempt. cMade cit cillegal cfor cdoctors cto cprescribe cnarcotics cto caddicts cto cween
cthem coff. cPatent cmedicines cgot cthe cpeople caddicted, cand cthe cndoctors ccouldn't cdo
canything
Sulfanilamide celixir ctragedy c- cCORRECT cANS✔✔1937. cMedication cfor cstrep cthroat
cwas cprepared cin cliquid cform cusing cdiethylene cglycol cand craspberry cflavoring
cwithout csafety ctests. cMany cpatients, cmostly cchildren, cdied cfrom ckidney cfailure.
not ctechnically can celixir cbecause cit ccontained cno calcohol c(not cbecause cit ccaused
ckidney cfailure cand cdeath) c- cCORRECT cANS✔✔why cwas cthe csulfanilamide celixir
clegally cprosecuted?
deaths cfrom cradium cinfused cwater c- cCORRECT cANS✔✔in cthe cearly c1930s, cwhat
ctype cof ctragedy coccured?
Food, cDrug, cand cCosmetic cAct c- cCORRECT cANS✔✔1938. cMade cit ca claw cthat
ctherapeutic cclaims cmust cagree cwith cmedical copinion cand clabels cmust ccontain call
cingredients cpresent. cThose cwith cnarcotics cor chypnotics cmust chave ca cwarning clabel
cthat cthese ccan cbe chabit cforming. cMade csafety ctests crequired cand call cnew cdrugs
crequired cprescription
Prescription cDrug cAmendment c- cCORRECT cANS✔✔fixed cissue cof cthe cFood, cdrug
cand ccosmetic cact, callowing cover cthe ccounter cdrug clicensing cto coccur
, Dr. cFrances cKelsey c- cCORRECT cANS✔✔Doctor cassociated cwith cblocking capproval
cfor cthalidimide cusage cin cthe cUS cbecause cshe cwas cconcerned cwith cits cneuropathic
cside ceffects cand cability cto ccross cplacenta
Kefauver-Harris cAmendment c- cCORRECT cANS✔✔1962, cmade cclinical ctrials cdouble
cblind, cand cpharmaceuticals chad cto cbe ctested cfor cteratgenecity cin ctwo cspecies.
cEnhanced cFDA cmonitoring, cmade cinformed cconsent crequried, cand callowed cfor
crestrospective creview cof cdrugs con cthe cmarket
Controlled cSubstance cAct c- cCORRECT cANS✔✔1970- cregulates cdrugs cwith cabuse
cpotential, cand cestablished cthe cschedules cthat cdrugs care cplaced cinto
Schedule c1 cdrug c- cCORRECT cANS✔✔if ca cdrug chas cno cmedicinal cuse, cit cis
cconsidered ca...
clioquinol c- cCORRECT cANS✔✔over cthe ccounter cdrug cfor camebic cdiarrhea, cbut
cJapanese ctook cit cregularly cfor cany cstomach cpain. cCaused cneuropathy cand
cblindness cand cparalysis
no c- cCORRECT cANS✔✔is cthere cany cdrug con cthe cmarket cthat cpresents cno cdrug
cdrug cinteractions cor cside ceffects?
12 cto c25 cyears c- cCORRECT cANS✔✔how clong cdoes cit ctake ca cnew cdrug cto cmake
cit cto cthe cmarket?
idea cdevelopment cand csearch cfor cnew cmedicine c- cCORRECT cANS✔✔what
chappens cduring cthe cdiscovery cand cdevelopment cphase cof cdrug cdevelopment?
preclinical cresearch, cdeveloping cthe cproduct cand cproduction cschemes, cand
cregulatory creview cand capproval c- cCORRECT cANS✔✔what coccurs cin cthe
cpreclinical cdevelopment cstage cof cdrug cdevelopment
Phase cI c- cCORRECT cANS✔✔phase cof cclinical ctrials cin cwhich conly chealthy chumans
care cused cto ctest cpharmacokinetics cof cthe cdrug cto cfind cbest cdose cand croute cof
cadministration
Phase cII c- cCORRECT cANS✔✔phase cof cclinical ctrials cin cwhich ca cfew chundred
cpatients cwith cthe cdisease cto csee cif cdrug cworks cand cat cwhat cdose. cOverall: csafety
cand cactivity
Phase cIII c- cCORRECT cANS✔✔phase cof cclinical ctrials cfocusing con ccomparative
cefficacy crelative cto cestablished ctreatments, cand cused cto cidentify cadverse cside
ceffects
Phase cIV c- cCORRECT cANS✔✔phase cof cdrug cdevelopment cthat cfocuses con cpost
cmarketing creview cof cnew cdrugs
Correct Answers
patent cmedicines c- cCORRECT cANS✔✔products cthat cwere csold, cmost coften cin cthe
c19th ccentury, cas cmedicines cthat cwould ccure ca chost cof cillnesses cand cdiseases
medicine cwith cpoisonous csubstances cmust cbe clabeled cas cpoisonous con cbottles c-
cCORRECT cANS✔✔the cfirst cdrug cregulations cin cthe cmid-1800s crequired cthat...
Pure cFood cand cDrug cAct c- cCORRECT cANS✔✔Drug cregulation cin c1906 cthat
crequired cmedicine clabels cbe ctruthful cand clist cany cingredients cthat cwere ca cpart cof ca
clist cof c10 caddictive cor cdangerous csubstances. cEnforced cby cthe cUSDA cBureau cof
cChemistry
Harrison cNarcotics cAct c- cCORRECT cANS✔✔1914, cestablished cfee cto clicense
cnarcotics cfor cmanufacturers cand cprescribers cof cnarcotics. cPatent cmedicine cwas
cexempt. cMade cit cillegal cfor cdoctors cto cprescribe cnarcotics cto caddicts cto cween
cthem coff. cPatent cmedicines cgot cthe cpeople caddicted, cand cthe cndoctors ccouldn't cdo
canything
Sulfanilamide celixir ctragedy c- cCORRECT cANS✔✔1937. cMedication cfor cstrep cthroat
cwas cprepared cin cliquid cform cusing cdiethylene cglycol cand craspberry cflavoring
cwithout csafety ctests. cMany cpatients, cmostly cchildren, cdied cfrom ckidney cfailure.
not ctechnically can celixir cbecause cit ccontained cno calcohol c(not cbecause cit ccaused
ckidney cfailure cand cdeath) c- cCORRECT cANS✔✔why cwas cthe csulfanilamide celixir
clegally cprosecuted?
deaths cfrom cradium cinfused cwater c- cCORRECT cANS✔✔in cthe cearly c1930s, cwhat
ctype cof ctragedy coccured?
Food, cDrug, cand cCosmetic cAct c- cCORRECT cANS✔✔1938. cMade cit ca claw cthat
ctherapeutic cclaims cmust cagree cwith cmedical copinion cand clabels cmust ccontain call
cingredients cpresent. cThose cwith cnarcotics cor chypnotics cmust chave ca cwarning clabel
cthat cthese ccan cbe chabit cforming. cMade csafety ctests crequired cand call cnew cdrugs
crequired cprescription
Prescription cDrug cAmendment c- cCORRECT cANS✔✔fixed cissue cof cthe cFood, cdrug
cand ccosmetic cact, callowing cover cthe ccounter cdrug clicensing cto coccur
, Dr. cFrances cKelsey c- cCORRECT cANS✔✔Doctor cassociated cwith cblocking capproval
cfor cthalidimide cusage cin cthe cUS cbecause cshe cwas cconcerned cwith cits cneuropathic
cside ceffects cand cability cto ccross cplacenta
Kefauver-Harris cAmendment c- cCORRECT cANS✔✔1962, cmade cclinical ctrials cdouble
cblind, cand cpharmaceuticals chad cto cbe ctested cfor cteratgenecity cin ctwo cspecies.
cEnhanced cFDA cmonitoring, cmade cinformed cconsent crequried, cand callowed cfor
crestrospective creview cof cdrugs con cthe cmarket
Controlled cSubstance cAct c- cCORRECT cANS✔✔1970- cregulates cdrugs cwith cabuse
cpotential, cand cestablished cthe cschedules cthat cdrugs care cplaced cinto
Schedule c1 cdrug c- cCORRECT cANS✔✔if ca cdrug chas cno cmedicinal cuse, cit cis
cconsidered ca...
clioquinol c- cCORRECT cANS✔✔over cthe ccounter cdrug cfor camebic cdiarrhea, cbut
cJapanese ctook cit cregularly cfor cany cstomach cpain. cCaused cneuropathy cand
cblindness cand cparalysis
no c- cCORRECT cANS✔✔is cthere cany cdrug con cthe cmarket cthat cpresents cno cdrug
cdrug cinteractions cor cside ceffects?
12 cto c25 cyears c- cCORRECT cANS✔✔how clong cdoes cit ctake ca cnew cdrug cto cmake
cit cto cthe cmarket?
idea cdevelopment cand csearch cfor cnew cmedicine c- cCORRECT cANS✔✔what
chappens cduring cthe cdiscovery cand cdevelopment cphase cof cdrug cdevelopment?
preclinical cresearch, cdeveloping cthe cproduct cand cproduction cschemes, cand
cregulatory creview cand capproval c- cCORRECT cANS✔✔what coccurs cin cthe
cpreclinical cdevelopment cstage cof cdrug cdevelopment
Phase cI c- cCORRECT cANS✔✔phase cof cclinical ctrials cin cwhich conly chealthy chumans
care cused cto ctest cpharmacokinetics cof cthe cdrug cto cfind cbest cdose cand croute cof
cadministration
Phase cII c- cCORRECT cANS✔✔phase cof cclinical ctrials cin cwhich ca cfew chundred
cpatients cwith cthe cdisease cto csee cif cdrug cworks cand cat cwhat cdose. cOverall: csafety
cand cactivity
Phase cIII c- cCORRECT cANS✔✔phase cof cclinical ctrials cfocusing con ccomparative
cefficacy crelative cto cestablished ctreatments, cand cused cto cidentify cadverse cside
ceffects
Phase cIV c- cCORRECT cANS✔✔phase cof cdrug cdevelopment cthat cfocuses con cpost
cmarketing creview cof cnew cdrugs
