PHM 351 - Exam #1questions With
Correct Answers
What cwere cthe cfirst cregulations cimposed con cmedicines? c- cCORRECT
cANS✔✔Items cconsidered cpoisonous cwere csupposed cto cbe clabelled con cbottles
What cdid cthe cPure cFood cand cDrugs cAct cregulate? c- cCORRECT cANS✔✔·
cAmendment cin c1912 coutlawed cfraudulent ctherapeutic cclaims
· cDrugs cor cfood cwere crequired cto clist cany cof c10 cingredients cincluding cmorphine,
copium, cheroin, ccocaine, calpha cor cbeta ceucaine, ccannabis, cchloroform, cchloral
chydrate, cacetanilide, calcohol
Why cwas cthe cHarrison cNarcotic cAct ccontroversial? cWhy cdid cit ccause cproblems cfor
cphysicians? c- cCORRECT cANS✔✔· cPrescriptions cwere crequired cfor cnarcotics cand
ccould cnot cbe cgiven cto caddicts
· cDid cnot callow cdoctors cto cprescribe cnarcotics cto caddicts, conly cto cpatients c-
caddiction cwas cnot cconsidered ca cdisease
What cis can cexample cof ca cpatent cmedicine cor clicensed cdrug cthat ccaused csignificant
cnegative chealth ceffects/deaths cin cthe cU.S. cbefore c1960? c- cCORRECT cANS✔✔·
cSulfanilamide, ca cliquid cantibiotic, cwas cdissolved cin cdiethylene c(poisonous) cbecause
cit ctastes csweet. cLead cto ckidney cand cneurologic cdamage, cdeath.
· cLiquid cradium, cadvertised cto cenhance csex cdrive ccontained cradium cwhich ccaused
cpoisoning cand cdeath
What cadvances cdid cthe cFood, cDrug cand cCosmetic cAct cprovide ctoward cdrug
csafety? c- cCORRECT cANS✔✔· cLabels cmust cinclude call cingredients
· cWarning clabels cfor caddictive csubstances
· cNew cdrugs conly cavailable cwith ca cphysician's corder
What cwere cthe cseries cof cevents csurrounding cthe cmarketing cof cthalidomide? cWhat
charmful ceffects cdoes cit ccause? cWhy cwasn't cit ccaught cduring cpre-clinical ctesting?
cWho cwas ckey cin cpreventing cits capproval cin cthe cU.S? c- cCORRECT cANS✔✔·
cThalidomide chad cbeen cfor csale cin cEurope cas ca ctreatment cfor cinsomnia cand
cmorning csickness cin cpregnant cwomen csince c1955.
· cThe ccompany cwas callowed cto cdetermine cthe cpre-market ctesting cand cwhat cwas
cenough cto csatisfy cit
· cThe cfirst cbaby cwith cphocomelia c(flipper-like climbs) cborn cfrom ca cmother ctaking
cthalidomide cwhile cpregnant cwas cin c1956
· cDr. cFrances cKelsey cdenied capproval cin cthe cU.S.
, Which csection cof cthe cKefauver-Harris cBill cis cdirectly crelated cto cthe ctragedy cseen
cwith cbringing cthalidomide cto cthe chuman cmarket? c- cCORRECT cANS✔✔"Human
cpharmaceutics care ctested cfor cteratogenicity cin c2 cspecies"
What care cthe cmajor cphases cof cdrug cdevelopment? c- cCORRECT cANS✔✔1.
cDiscovery
*pre-IND cmeeting*
2. cPreclinical cdevelopment
*initial cIND csubmission*
3. cClinical cdevelopment
4. cRegistration
5. cPost-market csecurity csurveillance
Discovery c- cCORRECT cANS✔✔· cDevelop can cidea
· cSearch cfor cnew cmedicine
Preclinical cDevelopment c- cCORRECT cANS✔✔· cResearch
· cProcess c& cproduct cdevelopment
· cRegulatory creview c& capproval
Clinical cdevelopment c- cCORRECT cANS✔✔· cPhase c1 c- cdose cfinding: chealthy
chumans
· cPhase c2 c- csafety c& cactivity: cevaluation cof cresponse cvs cdose cin chumans cwith cthe
cdisease
· cPhase c3 c- ccomparative cefficacy: cconfirm ceffectiveness, cidentify cadverse ceffects
cand clong-term ctoxicology cstudies, c*pre-NDA cmeeting*
Registration c- cCORRECT cANS✔✔Regulatory creview
Post-market csecurity csurveillance c- cCORRECT cANS✔✔Phase c4, cregulatory
crequirements
Which c"Center" cand c"Office" care cresponsible cfor creviewing cnew chuman cdrug
capplications cat cthe cFDA? c- cCORRECT cANS✔✔Center cfor cDrug cEvaluation cand
cResearch c(CDER) c& cthe cOffice cof cNew cDrugs
What ctype cof csafety cinformation cmust cbe cprovided con can cInvestigational cNew cDrug
c(IND) capplication? c- cCORRECT cANS✔✔· cAnimal cpharmacology c& ctoxicology
cstudies
· cManufacturing cinformation
· cClinical cprotocols c& cinvestigator cinformation
What csafety cinformation cmust cbe cprovided con ca cNew cDrug cApplication c(NDA)? c-
cCORRECT cANS✔✔Tells ca ccomplete cstory cof cthe ccompound c- cenough cinformation
cto cdetermine:
Correct Answers
What cwere cthe cfirst cregulations cimposed con cmedicines? c- cCORRECT
cANS✔✔Items cconsidered cpoisonous cwere csupposed cto cbe clabelled con cbottles
What cdid cthe cPure cFood cand cDrugs cAct cregulate? c- cCORRECT cANS✔✔·
cAmendment cin c1912 coutlawed cfraudulent ctherapeutic cclaims
· cDrugs cor cfood cwere crequired cto clist cany cof c10 cingredients cincluding cmorphine,
copium, cheroin, ccocaine, calpha cor cbeta ceucaine, ccannabis, cchloroform, cchloral
chydrate, cacetanilide, calcohol
Why cwas cthe cHarrison cNarcotic cAct ccontroversial? cWhy cdid cit ccause cproblems cfor
cphysicians? c- cCORRECT cANS✔✔· cPrescriptions cwere crequired cfor cnarcotics cand
ccould cnot cbe cgiven cto caddicts
· cDid cnot callow cdoctors cto cprescribe cnarcotics cto caddicts, conly cto cpatients c-
caddiction cwas cnot cconsidered ca cdisease
What cis can cexample cof ca cpatent cmedicine cor clicensed cdrug cthat ccaused csignificant
cnegative chealth ceffects/deaths cin cthe cU.S. cbefore c1960? c- cCORRECT cANS✔✔·
cSulfanilamide, ca cliquid cantibiotic, cwas cdissolved cin cdiethylene c(poisonous) cbecause
cit ctastes csweet. cLead cto ckidney cand cneurologic cdamage, cdeath.
· cLiquid cradium, cadvertised cto cenhance csex cdrive ccontained cradium cwhich ccaused
cpoisoning cand cdeath
What cadvances cdid cthe cFood, cDrug cand cCosmetic cAct cprovide ctoward cdrug
csafety? c- cCORRECT cANS✔✔· cLabels cmust cinclude call cingredients
· cWarning clabels cfor caddictive csubstances
· cNew cdrugs conly cavailable cwith ca cphysician's corder
What cwere cthe cseries cof cevents csurrounding cthe cmarketing cof cthalidomide? cWhat
charmful ceffects cdoes cit ccause? cWhy cwasn't cit ccaught cduring cpre-clinical ctesting?
cWho cwas ckey cin cpreventing cits capproval cin cthe cU.S? c- cCORRECT cANS✔✔·
cThalidomide chad cbeen cfor csale cin cEurope cas ca ctreatment cfor cinsomnia cand
cmorning csickness cin cpregnant cwomen csince c1955.
· cThe ccompany cwas callowed cto cdetermine cthe cpre-market ctesting cand cwhat cwas
cenough cto csatisfy cit
· cThe cfirst cbaby cwith cphocomelia c(flipper-like climbs) cborn cfrom ca cmother ctaking
cthalidomide cwhile cpregnant cwas cin c1956
· cDr. cFrances cKelsey cdenied capproval cin cthe cU.S.
, Which csection cof cthe cKefauver-Harris cBill cis cdirectly crelated cto cthe ctragedy cseen
cwith cbringing cthalidomide cto cthe chuman cmarket? c- cCORRECT cANS✔✔"Human
cpharmaceutics care ctested cfor cteratogenicity cin c2 cspecies"
What care cthe cmajor cphases cof cdrug cdevelopment? c- cCORRECT cANS✔✔1.
cDiscovery
*pre-IND cmeeting*
2. cPreclinical cdevelopment
*initial cIND csubmission*
3. cClinical cdevelopment
4. cRegistration
5. cPost-market csecurity csurveillance
Discovery c- cCORRECT cANS✔✔· cDevelop can cidea
· cSearch cfor cnew cmedicine
Preclinical cDevelopment c- cCORRECT cANS✔✔· cResearch
· cProcess c& cproduct cdevelopment
· cRegulatory creview c& capproval
Clinical cdevelopment c- cCORRECT cANS✔✔· cPhase c1 c- cdose cfinding: chealthy
chumans
· cPhase c2 c- csafety c& cactivity: cevaluation cof cresponse cvs cdose cin chumans cwith cthe
cdisease
· cPhase c3 c- ccomparative cefficacy: cconfirm ceffectiveness, cidentify cadverse ceffects
cand clong-term ctoxicology cstudies, c*pre-NDA cmeeting*
Registration c- cCORRECT cANS✔✔Regulatory creview
Post-market csecurity csurveillance c- cCORRECT cANS✔✔Phase c4, cregulatory
crequirements
Which c"Center" cand c"Office" care cresponsible cfor creviewing cnew chuman cdrug
capplications cat cthe cFDA? c- cCORRECT cANS✔✔Center cfor cDrug cEvaluation cand
cResearch c(CDER) c& cthe cOffice cof cNew cDrugs
What ctype cof csafety cinformation cmust cbe cprovided con can cInvestigational cNew cDrug
c(IND) capplication? c- cCORRECT cANS✔✔· cAnimal cpharmacology c& ctoxicology
cstudies
· cManufacturing cinformation
· cClinical cprotocols c& cinvestigator cinformation
What csafety cinformation cmust cbe cprovided con ca cNew cDrug cApplication c(NDA)? c-
cCORRECT cANS✔✔Tells ca ccomplete cstory cof cthe ccompound c- cenough cinformation
cto cdetermine:
