PHM 351 EXAM QUESTIONS WITH
CORRECT ANSWERS
What care cthe cmajor cphases cof cdrug cdevelopment? c- cCORRECT cANS✔✔Discovery
Preclinical cdevelopment
Clinical cdevelopment c(1,2,3)
Registration
Post cMarketing
Which ccenter cand coffice care cresponsible cfor creviewing chuman cdrug capplications cat
cthe cFDA? c- cCORRECT cANS✔✔Center cfor cdrug cevaluation. coffice cof cnew cdrugs
What ctype cof csafety cinformation cmust cbe cprovided con can cinvestigational cNew cDrug
c(ND) capplication? c- cCORRECT cANS✔✔Animal cand cpharmacology cand ctoxicology
cstudies: cdiscovery cand cpreclinical cdevelopment cinfo cshows cthat cthe cdrug cis
creasonably csafe cfor chuman ctesting
Manufacturing cinformation: cmanufacturer, cstability. ccomposition, cand ccontrols
Preclinical cprotocols cand cinvestigator cinformation: cprotocols cof cthe cproposed cclinical
cstudies cto censure cthere care cno cunnecessary crisks
What csafety cinfo cmust cbe cproved con cNDAs? c- cCORRECT cANS✔✔information cfrom
cdiscovery cto cclinical ctrials cthat cdetermine cwhether cthe cdrug cis csafe cand ceffective
cfor cproposed cuse, cthe cbenefits coutweigh cthe crisks, cwhat cthe cdrug cpacket clabel cwill
ccontain, cwhether cthe cmanufacturing cmethod cis cadequate
How cdoes cthe cFDA cweigh csafety cinfo cto cmake ca cdecision cabout chuman cdrug
capprovals? c- cCORRECT cANS✔✔They chave c2 cvoluntary creporting cand crisk
cassessment cprograms: cFDA cadverse cevent creporting csystem c(FAERS) cfor
chealthcare cproviders, cconsumers, cor cthe cdrug cmanufactures cand cmedwatch cwhich
cis cfor cthe cpublic cand cmedical cprofessionals
How care cnew canimal cdrug capprovals cregulations cdifferent cfrom chuman cdrug
capprovals? c- cCORRECT cANS✔✔If cthe cdrugs cwill cbe cgiven cto cfood-producing
canimals cthen cfood csafety cstudies cmust cbe cconducted
Potentials cfor chuman csafety cof cdrugs cby csimple ccontact cwith cdrugs cbeing
cadministered cto cand canimal cor cby ccontacting cthe cdrug cin canimal cwaste
Environmental cimpact cstatement
What cis cAMDUCA? c- cCORRECT cANS✔✔The canimal cmedicinal cdrug cuse
cclarification cact cof c1994 cwhich cpermits cvets cto cprescribe cextralabel cuses cof ccertain
, capproved cnew canimal cdrugs cand capproved chuman cdrugs cfor canimals cunder
ccertain cconditions
What cdrug csafety cinfo ccan cin-silico cmodels chelp cto cpredict? c- cCORRECT
cANS✔✔Off ctarget cinteractions- cbinding cor cactivity cat cunintended csites, ctests cto csee
cif cdrug cis caffecting cother cparts cof cthe cbody
Dug-drug cinteractions- cespecially cmetabolizing cenzymes, cthey ccan calso cpredict
cinteractions cwith ctransporters
Advantages cand cdisadvantages cof cin-silico? c- cCORRECT cANS✔✔you ccan cscreen
cfor ca clot cof cpotential ctoxicities, cit cdoesn't charm canything. cThe cFDA cdoes cnot
caccept cinsilico cas csufficient cresults
What cdrug csafety ccan cin-vitro cmodels cprovide? c- cCORRECT cANS✔✔Cell cbased:
ccytotoxicity, cdoes cthe cdrug ccause ccell cdeath ctests cfor ctherapeudic cdoses cby
ctesting corgans, ctissue, cand creceptors, chERG c
Cell cfree: ccytochrome cp450 cinteractions
What cinformation cdo cin-vitro cmodels clack? c- cCORRECT
cANS✔✔Absorption/excretion/ cdistribution- chow cit's ctaken cin cby cthe cplasma cand
cexcreted
Whole canimal cdrug cmetabolism-how cthe cdrug cis cmetabolized
Why care ccytochrome cp450 cassays cimportant cto cdrug csafety? c- cCORRECT
cANS✔✔They care cenzymes cin cthe cliver cthat cmetabolize cnumerous cpharmaceuticals
cif ca cdrug cinhibits cthese cenzymes cthere ccould cbe cbad cdrug-drug cinteractions
What cis cthe chERG cchannel? cWhy cis cit cimportant cin cearly cdrug csafety ctesting?
cWhat cis can cexample cof can cin-vitro cassay cthat ccan cbe cused cto cspecifically cidentify
cdrug cinteraction cwith cthe chERG cchannel? c- cCORRECT cANS✔✔This ctest cis cdone
cto ccheck cto csee cif cthere cis cany carrhythmias ccaused cby cthe cdrug, crunning ca cECG
What cdata cis ctypically ccollected c(or cwhat cchanges care cmonitored) cfrom cin cvivo
ctoxicity cstudies? cWhat cspecies care cusually cused? c- cCORRECT cANS✔✔Lethality,
corgan ctoxicity, ctolerability cindicators
Rats
When care cthe cdifferent ctests cconducted cduring cthe cdrug cdevelopment cprocess? c-
cCORRECT cANS✔✔reproductive cand cdevelopmental, ccarcinogenicy, cgenotoxicity
Why cmight csome creproductive csafety ctests cnot cbe crequired cfor csome cdrugs cto cgo
cto cclinical ctrials cor con cmarket? c- cCORRECT cANS✔✔
Understand cthe c3 cmutagenicity cassays cdescribed. cWhat ckind cof ccells c(bacterial cor
cmammalian) cor cin cvivo cmodel cis cused cin ceach cand cwhat cresult cis cobserved? c-
cCORRECT cANS✔✔Mutagenicy cAssay c(ames)- cinvitro cbacteria ccells
CORRECT ANSWERS
What care cthe cmajor cphases cof cdrug cdevelopment? c- cCORRECT cANS✔✔Discovery
Preclinical cdevelopment
Clinical cdevelopment c(1,2,3)
Registration
Post cMarketing
Which ccenter cand coffice care cresponsible cfor creviewing chuman cdrug capplications cat
cthe cFDA? c- cCORRECT cANS✔✔Center cfor cdrug cevaluation. coffice cof cnew cdrugs
What ctype cof csafety cinformation cmust cbe cprovided con can cinvestigational cNew cDrug
c(ND) capplication? c- cCORRECT cANS✔✔Animal cand cpharmacology cand ctoxicology
cstudies: cdiscovery cand cpreclinical cdevelopment cinfo cshows cthat cthe cdrug cis
creasonably csafe cfor chuman ctesting
Manufacturing cinformation: cmanufacturer, cstability. ccomposition, cand ccontrols
Preclinical cprotocols cand cinvestigator cinformation: cprotocols cof cthe cproposed cclinical
cstudies cto censure cthere care cno cunnecessary crisks
What csafety cinfo cmust cbe cproved con cNDAs? c- cCORRECT cANS✔✔information cfrom
cdiscovery cto cclinical ctrials cthat cdetermine cwhether cthe cdrug cis csafe cand ceffective
cfor cproposed cuse, cthe cbenefits coutweigh cthe crisks, cwhat cthe cdrug cpacket clabel cwill
ccontain, cwhether cthe cmanufacturing cmethod cis cadequate
How cdoes cthe cFDA cweigh csafety cinfo cto cmake ca cdecision cabout chuman cdrug
capprovals? c- cCORRECT cANS✔✔They chave c2 cvoluntary creporting cand crisk
cassessment cprograms: cFDA cadverse cevent creporting csystem c(FAERS) cfor
chealthcare cproviders, cconsumers, cor cthe cdrug cmanufactures cand cmedwatch cwhich
cis cfor cthe cpublic cand cmedical cprofessionals
How care cnew canimal cdrug capprovals cregulations cdifferent cfrom chuman cdrug
capprovals? c- cCORRECT cANS✔✔If cthe cdrugs cwill cbe cgiven cto cfood-producing
canimals cthen cfood csafety cstudies cmust cbe cconducted
Potentials cfor chuman csafety cof cdrugs cby csimple ccontact cwith cdrugs cbeing
cadministered cto cand canimal cor cby ccontacting cthe cdrug cin canimal cwaste
Environmental cimpact cstatement
What cis cAMDUCA? c- cCORRECT cANS✔✔The canimal cmedicinal cdrug cuse
cclarification cact cof c1994 cwhich cpermits cvets cto cprescribe cextralabel cuses cof ccertain
, capproved cnew canimal cdrugs cand capproved chuman cdrugs cfor canimals cunder
ccertain cconditions
What cdrug csafety cinfo ccan cin-silico cmodels chelp cto cpredict? c- cCORRECT
cANS✔✔Off ctarget cinteractions- cbinding cor cactivity cat cunintended csites, ctests cto csee
cif cdrug cis caffecting cother cparts cof cthe cbody
Dug-drug cinteractions- cespecially cmetabolizing cenzymes, cthey ccan calso cpredict
cinteractions cwith ctransporters
Advantages cand cdisadvantages cof cin-silico? c- cCORRECT cANS✔✔you ccan cscreen
cfor ca clot cof cpotential ctoxicities, cit cdoesn't charm canything. cThe cFDA cdoes cnot
caccept cinsilico cas csufficient cresults
What cdrug csafety ccan cin-vitro cmodels cprovide? c- cCORRECT cANS✔✔Cell cbased:
ccytotoxicity, cdoes cthe cdrug ccause ccell cdeath ctests cfor ctherapeudic cdoses cby
ctesting corgans, ctissue, cand creceptors, chERG c
Cell cfree: ccytochrome cp450 cinteractions
What cinformation cdo cin-vitro cmodels clack? c- cCORRECT
cANS✔✔Absorption/excretion/ cdistribution- chow cit's ctaken cin cby cthe cplasma cand
cexcreted
Whole canimal cdrug cmetabolism-how cthe cdrug cis cmetabolized
Why care ccytochrome cp450 cassays cimportant cto cdrug csafety? c- cCORRECT
cANS✔✔They care cenzymes cin cthe cliver cthat cmetabolize cnumerous cpharmaceuticals
cif ca cdrug cinhibits cthese cenzymes cthere ccould cbe cbad cdrug-drug cinteractions
What cis cthe chERG cchannel? cWhy cis cit cimportant cin cearly cdrug csafety ctesting?
cWhat cis can cexample cof can cin-vitro cassay cthat ccan cbe cused cto cspecifically cidentify
cdrug cinteraction cwith cthe chERG cchannel? c- cCORRECT cANS✔✔This ctest cis cdone
cto ccheck cto csee cif cthere cis cany carrhythmias ccaused cby cthe cdrug, crunning ca cECG
What cdata cis ctypically ccollected c(or cwhat cchanges care cmonitored) cfrom cin cvivo
ctoxicity cstudies? cWhat cspecies care cusually cused? c- cCORRECT cANS✔✔Lethality,
corgan ctoxicity, ctolerability cindicators
Rats
When care cthe cdifferent ctests cconducted cduring cthe cdrug cdevelopment cprocess? c-
cCORRECT cANS✔✔reproductive cand cdevelopmental, ccarcinogenicy, cgenotoxicity
Why cmight csome creproductive csafety ctests cnot cbe crequired cfor csome cdrugs cto cgo
cto cclinical ctrials cor con cmarket? c- cCORRECT cANS✔✔
Understand cthe c3 cmutagenicity cassays cdescribed. cWhat ckind cof ccells c(bacterial cor
cmammalian) cor cin cvivo cmodel cis cused cin ceach cand cwhat cresult cis cobserved? c-
cCORRECT cANS✔✔Mutagenicy cAssay c(ames)- cinvitro cbacteria ccells
