Exam (elaborations)
HOSA Pharmacology (Latest 2024/ 2025 Update) Qs & As| Grade A| 100% Correct (Verified Answers)
HOSA,Pharmacology (Latest 2024/ 2025 Update) Qs & As| Grade A| 100% Correct (Verified Answers)
Q: NDA Process: Initial Development: Pre Clinical
Answer:
pre-clinical (animal) testing
Q: NDA Process: Initial Development: Investigational New Drug Review (IND)
Answer:
-review...
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1. Exam (elaborations) - Hosa pharmacology (latest 2024/ 2025 update) qs & as| grade a| 100% correct (verified...
2. Exam (elaborations) - Hosa pharmacology (2024/ 2025 update) qs & as| grade a| 100% correct (verified answer...
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HOSAlPharmacologyl(LatestlUpdate)lQsl&l
As|lGradelA|l100%lCorrectl(Verifiedl
Answers)
Q:lNDAlProcess:lInitiallDevelopment:lPrelClinical
Answer:
pre-clinicall(animal)ltesting
Q:lNDAlProcess:lInitiallDevelopment:lInvestigationallNewlDruglReviewl(IND)
Answer:
-reviewloflpre-clinicalltriallresults
-determinationloflsafetyltoluselonlhumans
-authorizationltolshiplacrosslstatellines
Q:lNDAlProcess:lNewlDruglClinicallTrials:lPhaselI
Answer:
-involvesl25-100lvolunteers
-safetyltoleratedldosageldetermined
-identificationloflmajorlsideleffects
-emphasislonlsafetylandlmaximumltoleratedldosages
Q:lNDAlProcess:lNewlDruglClinicallTrials:lPhaselII
,Answer:
-involvesl100-300lvolunteers
-emphasislonltheldrugleffectlagainstlwhatlit'sldesignedltoltreat
-effetslcomparedlwithlsimilarlpatientslreceivingldifferentltreatments
Q:lNDAlProcess:lNewlDruglClinicallTrials:lPhaselIII
Answer:
-involvesl300-3000lvolunteers
-emphasislonltheldrugsloverallleffect
-effectslcomparedlwithlpatientsltakinglplacebos
-studylofldifferentlpopulationlandldifferentldosages
-testingltheldruglinlcombinationlwithlotherldrugs
-finallphaselbeforelpresentingltolFDAlforlapproval
Q:lNDAlProcess:lNewlDruglPostlApprovallTrials:lPhaselIV
Answer:
-ongoing/postlapprovalltrials
-health-carelprofessionalsltolreportlanyladverselfindings
-lastsleternally,lasllonglasltheldruglislonlthelmarket
Q:lNDAlProcesslTime
Answer:
-canlusuallyltakel12-15lyears
-patentlonlyllastl20lyearslfromltheltimelthelapplicationlforlpatentlwaslfilled
Q:lFederallFoodlandlDruglActlofl1906
,Answer:
-knownlaslthelPurelFoodlandlDruglAct
-
providedlauthoritylforlfederallinspectionloflmeatlproductslandlprohibitedlthelsalelofladulteratedl
foods
-
requiredlthatl"secretlelixirs"lcontaininglingredientsllike:lcocaine,lheroin,lmorphinelandlalcoholl
whichlwerelavailablelatlmostlstoreslaslmiraclelcure-
allslbellabeledlwithlcorrectlinformationlaboutltheirlingredientslaslwelllaslsuggestedldosages
-replacedlbylthelFederallFood,lDruglandlCosmeticlActlofl1938
Q:lNarcoticlTaxlActlofl1914
Answer:
-knownlaslthelHarrisonlNarcoticlAct
-providedlauthoritylforlthelIRSltolcollectltaxeslonlOpiateslthrultaxlstamps
-
requiredlthatlanylentitylwhichlproduced,ldistributed,ldispensedlorlsoldlopiateslbelregisteredlwit
hlthelIRS
-
emphasislwaslonlattemptingltolcontrollthelmassivelflowloflopiateslinlorderltolprotectlthelpublicl
fromlrisingladdiction
Q:lFederallFood,lDruglandlCosmeticlActlofl1938
Answer:
-knownlaslFDCAl1938
-replacedlthelFoodlandlDruglactlofl1906
-providedlbetterlclarificationlaboutlmisbrandingldefinitions
-providedlbetterlclarificationlaboutladulterationldefinitions
-gavelthelFDAlauthorityltolrequireladequateltestingloflnewldrugslforlsafety
Q:lThelDurham-HumphreylAmendmentlofl1951
, Answer:
-createdlaldistinctionlbetweenl"OTC"landl"LegendlDrugs"
-
requiredllegendldrugsltolcarrylthelstatement:l"Caution:lFederalllawlprohibitsldispensinglwithout
lalprescription."
-emphasislonlthislactlwasltolinsurelsafetylthroughlqualifiedlmedicallsupervision
Q:lThelKefauver-HarrislAmendmentlofl1962
Answer:
-knownlaslthel"DruglEfficacylAmendment"
-
requiredldruglmanufacturersltolprovidelprooflofltheleffectivenesslandlsafetylofltheirldrugslbefor
elapproval
-
requiredldrugladvertisingltolbelmorelcloselylregulatedlandldiscloselaccuratelinformationlaboutls
ideleffects
Q:lThelBureauloflNarcoticslandlDangerouslDrugsl(BNDD)
Answer:
-predecessorlagencyloflthelDEA
-BNDDlmergedlintolthelDEAlinl1973
Q:lDruglAbuselPrevention/lControllActlofl1970
Answer:
-knownlaslthelCSA
-completelylreplacedlthelHarrisonlAct
-requiredltheluseloflDEAlnumbers
-requiredlcomprehensivelrecordlkeepinglandltransactionltracking