ANSWERS WITH SOLUTIONS 2024
PharmaLcompaniesLmustLsubmitLextensiveLdataLtoLtheLFDALdemonstratingLtheLsafetyLandLeffectivenessLofL
newLdrugsLbeforeLreceivingLapprovalLforLsale.L-LANSWERLTrue
AverageLreviewLtimeLforLaLnewLdrugL-LANSWERL18Lmonths
SalesLTeamL-LANSWERLPgL7
TheL"engineLofLinnovation,"LfocusedLonLdiscoveringLorLinventingLpromisingLnewLproduct.L-
LANSWERLResearchL&LDevelopment
ThisLincludesLsupplyLchain,Lmanufacturing,Ltrade,LandLdistributionLfunctionsLofLtheLbusiness.L-
LANSWERLManufacturingL&LOperations
InL2012,LFDALregulatorsLapprovedL39LnewLdrugsLforLuseLinLtheLU.S.L-LANSWERLTrue
3,070LnewLmedsLareLinLdevelopmentLforLcancer.L-LANSWERLTrue
DefineLOff-labelL-
LANSWERLUsageLofLaLmedicationLforLpurposesLotherLthanLtheLspecificLonesLappearingLonLtheLlabel
ToxicityL-LANSWERLTheLextent,Lquality,LorLdegreeLtoLwhichLaLsubstanceLisLpoisonousLorLharmfulLtoLtheLbody
InstitutionalLreviewLBoardL(IRB)L-
LANSWERLALcommitteeLofLphysicians,Lstaticians,LcommunityLadvocated,LandLothersLwhichLensureLthatLaLcli
nicalLtrialLisLethicalLandLthatLtheLrightsLofLtheLstudyLparticipantsLareLprotected.LAllLclinicalLtrialsLmustLbeLapp
rovedLbyLanLIRBLbeforeLtheyLbegin.
PlaceboL-LANSWERLInactiveLpill,Lliquid,LorLpowderLthatLhasLnoLtreatmentLvalueLakaLsugarLpill
,EdemaL-LANSWERLSwelling
AsymptomaticL-LANSWERLWithoutLsignsLorLsymptoms
ClinicalLPharmacologyL-LANSWERLTheLstudyLofLtheLeffectsLandLmovementLofLdrugsLinLtheLhumanLbody
AnatomyL-LANSWERLTheLstudyLofLbasicLstructuresLofLtheLbody
PhysiologyL-LANSWERLTheLstudyLofLhowLthoseLbodyLstructuresLfunction
BasicLclinicalLpharmacologyLinvolvesL3LmainLconceptsL-
LANSWERLPharmacodynamics,LPharmacokinetics,LdrugLdistributionLandLelimination.
PharmacodynamicsL-
LANSWERLStudyLofLtheLbiochemicalLandLphysiologicalLeffectsLofLdrugsLandLtheirLmechanismsLofLactionLi.e.Lt
heLstudyLofLwhatLaLdrugLdoesLtoLtheLbody.LItLdescribesLtheLtherapeuticLeffectsLofLdrugsL(painLrelief,LbloodLpr
essureLreduction,LtheirLsideLeffectsLandLtheirLsitesLofLaction.
PharmacokineticsL-
LANSWERLStudyLofLhowLaLdrugLisLprocessedLbyLtheLbody,LwithLemphasisLonLtheLtimeLrequiredLforLabsorptio
n,LdurationLofLaction,Ldistribution,LandLmethodLofLexcretion.LTheLstudyLofLhowLtheLbodyLaffectsLdrugs.
DrugLdistributionL&LeliminationL-
LANSWERLDrugLdeliveryLsystems,LrouteLofLadministrationL,LmodesLofLexcretion.
PlasmaL-LANSWERLTheLliquidLportionLofLtheLbloodLthatLcarriesLproteinsLandLotherLsubstances
OrgansL-
LANSWERLSpecializedLcellsLandLtissuesLgroupedLtogetherLtoLperformLspecificLbodyLfunctionLforLaLcommonLp
urpose.L(Kidney,Lheart,Lintestines,LandLskin)
NucleusL-LANSWERLBrainLofLtheLcellLthatLregulatesLallLactivities.
, ProteinsL-LANSWERLALnutrientLmadeLupLofLofLchainsLofLaminoLacids
FatsL-LANSWERLALnutrientLstoredLinLspecialLbodyLtissuesLasLaLgreatLsourceLofLreserveLenergy
CarbohydratesL-
LANSWERLALnutrientLthatLisLtheLbody'sLimmediateLsourceLofLenergy.LIt'sLbrokenLdownLtoLglucoseLandLusedLf
orLimmediateLmetabolicLreactions.
VitaminsL-
LANSWERLALnutrientLsubstanceLnecessaryLforLgrowth,Ldevelopment,LandLnormalLregulationLofLmetabolicLpr
ocesses.LMustLbeLtakenLfromLoutsideLtheLbody.
MineralsL-LANSWERLALnutrientLnecessaryLforLbodilyLpurposesLsuchLasLtheLbalanceLofLbodyLfluid
WaterLisLNOTLaLnutrientL-LANSWERLTrue
Body'sLMajorLSystemsL-
LANSWERLCardiovascular,LRespiratory,Lnervous,Lmusculoskeletal,Lreproductive,Limmune
AbsorptionL-LANSWERLHowLtheLdrugLpassesLfromLitsLsideLofLadministrationLintoLtheLbloodstream
DistributionL-LANSWERLHowLtheLdrugLisLdispersedLamongLtheLorgansLafterLabsorptionLintoLtheLblood
MetabolismL-LANSWERLHowLtheLactiveLpartLofLaLdrugLisLmetabolizedLintoLaLmoreLwater-
solubleLcompoundLthatLcanLbeLreadilyLexcretedLbyLtheLkidneys
ExcretionL-
LANSWERLHowLtheLdrugLisLeliminatedLfromLtheLbody.LUsuallyLdrugsLareLeliminatedLviaLurine.LTheyLcanLalsoL
beLexcretedLthroughLtheLlungs,Lskin,LorLbreastLmilk.
ItLtakesLaboutL10LyearsLforLaLdrugLtoLhitLtheLmarketL-LANSWERLTrue