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PHAR 100: 1.2 Drug Development And Drug Trials Exam Questions And Answers
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PHAR 100: 1.2 Drug Development And Drug Trials Exam Questions And Answers
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PHAR 100: 1.2 Drug Development AndDrug Trials Exam Questions And
Answers
Drugidevelopmentiisiaiwell-
establishediprocess.iIticanibeilargelyidividediintoifiveikeyisteps:i-
iCorrectiAnswer-
basiciresearchiandidrugidiscovery,ipreclinicalitrials,iclinicalitrials,iHealthi
Canadaireviewiandimanufacturing,ipost-
marketisurveillanceiandiphaseiIViclinicalitrials.
DrugiDiscoveryi-iCorrectiAnswer-
preclinicalistudiesi&idrugidevelopment;iusuallyitakesi3-6iyears
DrugiDevelopmenti-iCorrectiAnswer-ClinicaliTrialsithatitakei6-
7iyears.i(3iphasesi1:i10siofiparticipants,iphasei2:i100s,iphasei3:i1000s);iH
ealthiCanadaireviewiandiapprovaliwhichitakesi0.5i-i2iyears;ipost-
marketisurveillancei&iPhasei4iofitrialsiwhichiisiongoing
DrugiDiscovery:iBasiciResearchiandiDiscoveryiofiTargeti2istepsi-
iCorrectiAnswer-
Theifirstistepiinitheidrugidevelopmentiprocessiisibasicidrugiresearch.iThi
sistepicanibeifurtheribrokenidowniintoitheiidentificationiofiaitargetiforiai
drugitoiactioniandiaidetailedistudyiofitheiidentifieditarget.
,Stepi1iofiDrugiDiscovery:iIdentificationiofitheiTargeti-iCorrectiAnswer-
Aitargetiforiainewipotentialidrugicouldibeiaireceptorithat,iwheniactivate
d,icausesireliefiofipaini(receptorsiareiexplainediinimoreidetaililateriinithe
imodule).iOnceiaicompoundithatibindsiwellitoitheitargetiisiidentified,iiti
willibeistudieditoidetermineiitsipharmacologicalieffectsiatitheimolecular
,icellular,iorgan,iandiwholeianimalilevel.
Stepi2iofiDrugiDiscovery:iStudyingitheiTargeti-iCorrectiAnswer-
Ifiaicompoundishowsipromiseiinitheiinitialistudies,iitiisiidentifiediasiailea
dicompoundiandientersimoreidetailedistudiesiforisafetyiandiefficacy.iInit
heiexampleiofidevelopingiainewidrugitoirelieveipain,itheieffectiofitheidru
gionipainiwouldibeistudied.
PreclinicaliStudies:iIsitheiDrugiSafeiandiEffective?i-iCorrectiAnswer-
Afteritheidrugitargetihasibeenidiscoverediandisufficientlyistudied,itheidr
ugientersipreclinicalistudies.iPreclinicalistudiesiareiconductediprioritoite
stingitheinewidrugiinihumansiandirangeifromimoleculariandicellularistud
ies,itoitissueiandiwholeianimalistudies.
Twoimainicategoriesiofipreclinicalistudiesiexist:i-iCorrectiAnswer-
pharmacologyistudiesianditoxicologyistudies.
PharmacologyiStudiesi-iCorrectiAnswer-
Pharmacologyistudiesidetermineitheidetailedimechanismiofiactioniofith
einewidrug.iForiexample,iifitheidrugihasibeenidevelopeditoitreatihighiblo
odipressure,ihowitheidrugilowersibloodipressureiwouldibeideterminedi(
e.g.,idoesitheidrugidilateibloodivessels?).
, ToxicologyiStudiesi-iCorrectiAnswer-
Toxicologyistudiesidetermineitheipotentialirisksioriharmfulieffectsiofith
eidrug.iAllidrugsihaveisomeitoxicityiatisomeidoseiinisomeiindividuals.iStu
diesiwillibeiperformeditoilookiatiacuteitoxicity,ichronicitoxicity,iandieffe
ctsionireproductive,icarcinogenic,iandimutagenicipotential.iTheseistudi
esiareiexpensive,iandimayitakeiupitoisixiyearsitoicomplete.
ClinicaliTrials:Ifiaipharmaceuticalimanufactureriwishesitoitestiainewidru
gionihumansiiniaiclinicalitrial,ithreeimainistepsiareirequiredibeforeitheyic
aniproceed.i-iCorrectiAnswer-
proofiofisafety;imethodology;iinvestigation
Drugitesting,iProofiofiSafetyi-iCorrectiAnswer-
Theipharmaceuticalimanufacturerimustisubmitiproofiofitheisafetyiandie
fficacyiofitheidrugiiniseveralianimalispeciesitoitheigovernmentiregulator
yiagencyiinitheiparticularicountryiconcerned.iIniCanada,ithisiisitheiHealt
hiProductsiandiFoodiBranch,iandiinitheiU.S.A.,iitiisitheiFoodiandiDrugiAd
ministrationi(FiDiA).
Drugitesting,,iMethodologyi-iCorrectiAnswer-
Theimethodologyiofitheiproposediclinicalitrialiinihumansiisirequired.
Drugitesting,,iInvestigationi-iCorrectiAnswer-
Theisubmissioniisievaluatedibyiqualifiediscientistsiinitheiregulatoryiagen
cy.iIfitheyiareisatisfiediwithitheisubmission,ipermissioniwillibeigivenifori
highlyiqualifiediinvestigators,iusuallyiclinicalipharmacologists,itoibeginii
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