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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
Drug iidevelopment iiis iia iiwell-established iiprocess. iiIt iican iibe iilargely iidivided iiinto iifive
iikey iisteps: ii- iiAnswers ii-basic iiresearch iiand iidrug iidiscovery, iipreclinical iitrials, iiclinical
iitrials, iiHealth iiCanada iireview iiand iimanufacturing, iipost-market iisurveillance iiand
iiphase iiIV iiclinical iitrials.
Drug iiDiscovery ii- iiAnswers ii-preclinical iistudies ii& iidrug iidevelopment; iiusually iitakes
ii3-6 iiyears
Drug iiDevelopment ii- iiAnswers ii-Clinical iiTrials iithat iitake ii6-7 iiyears. ii(3 iiphases ii1: ii10s
iiof iiparticipants, iiphase ii2: ii100s, iiphase ii3: ii1000s); iiHealth iiCanada iireview iiand
iiapproval iiwhich iitakes ii0.5 ii- ii2 iiyears; iipost-market iisurveillance ii& iiPhase ii4 iiof iitrials
iiwhich iiis iiongoing
Drug iiDiscovery: iiBasic iiResearch iiand iiDiscovery iiof iiTarget ii2 iisteps ii- iiAnswers ii-The
iifirst iistep iiin iithe iidrug iidevelopment iiprocess iiis iibasic iidrug iiresearch. iiThis iistep iican
iibe iifurther iibroken iidown iiinto iithe iiidentification iiof iia iitarget iifor iia iidrug iito iiact iion iiand
iia iidetailed iistudy iiof iithe iiidentified iitarget.
Step ii1 iiof iiDrug iiDiscovery: iiIdentification iiof iithe iiTarget ii- iiAnswers ii-A iitarget iifor iia
iinew iipotential iidrug iicould iibe iia iireceptor iithat, iiwhen iiactivated, iicauses iirelief iiof iipain
ii(receptors iiare iiexplained iiin iimore iidetail iilater iiin iithe iimodule). iiOnce iia iicompound
iithat iibinds iiwell iito iithe iitarget iiis iiidentified, iiit iiwill iibe iistudied iito iidetermine iiits
iipharmacological iieffects iiat iithe iimolecular, iicellular, iiorgan, iiand iiwhole iianimal iilevel.
Step ii2 iiof iiDrug iiDiscovery: iiStudying iithe iiTarget ii- iiAnswers ii-If iia iicompound iishows
iipromise iiin iithe iiinitial iistudies, iiit iiis iiidentified iias iia iilead iicompound iiand iienters iimore
iidetailed iistudies iifor iisafety iiand iiefficacy. iiIn iithe iiexample iiof iideveloping iia iinew iidrug
iito iirelieve iipain, iithe iieffect iiof iithe iidrug iion iipain iiwould iibe iistudied.
Preclinical iiStudies: iiIs iithe iiDrug iiSafe iiand iiEffective? ii- iiAnswers ii-After iithe iidrug
iitarget iihas iibeen iidiscovered iiand iisufficiently iistudied, iithe iidrug iienters iipreclinical
iistudies. iiPreclinical iistudies iiare iiconducted iiprior iito iitesting iithe iinew iidrug iiin iihumans
iiand iirange iifrom iimolecular iiand iicellular iistudies, iito iitissue iiand iiwhole iianimal
iistudies.
, Two iimain iicategories iiof iipreclinical iistudies iiexist: ii- iiAnswers ii-pharmacology iistudies
iiand iitoxicology iistudies.
Pharmacology iiStudies ii- iiAnswers ii-Pharmacology iistudies iidetermine iithe iidetailed
iimechanism iiof iiaction iiof iithe iinew iidrug. iiFor iiexample, iiif iithe iidrug iihas iibeen
iideveloped iito iitreat iihigh iiblood iipressure, iihow iithe iidrug iilowers iiblood iipressure
iiwould iibe iidetermined ii(e.g., iidoes iithe iidrug iidilate iiblood iivessels?).
Toxicology iiStudies ii- iiAnswers ii-Toxicology iistudies iidetermine iithe iipotential iirisks iior
iiharmful iieffects iiof iithe iidrug. iiAll iidrugs iihave iisome iitoxicity iiat iisome iidose iiin iisome
iiindividuals. iiStudies iiwill iibe iiperformed iito iilook iiat iiacute iitoxicity, iichronic iitoxicity, iiand
iieffects iion iireproductive, iicarcinogenic, iiand iimutagenic iipotential. iiThese iistudies iiare
iiexpensive, iiand iimay iitake iiup iito iisix iiyears iito iicomplete.
Clinical iiTrials:If iia iipharmaceutical iimanufacturer iiwishes iito iitest iia iinew iidrug iion
iihumans iiin iia iiclinical iitrial, iithree iimain iisteps iiare iirequired iibefore iithey iican iiproceed.
ii- iiAnswers ii-proof iiof iisafety; iimethodology; iiinvestigation
Drug iitesting, iiProof iiof iiSafety ii- iiAnswers ii-The iipharmaceutical iimanufacturer iimust
iisubmit iiproof iiof iithe iisafety iiand iiefficacy iiof iithe iidrug iiin iiseveral iianimal iispecies iito
iithe iigovernment iiregulatory iiagency iiin iithe iiparticular iicountry iiconcerned. iiIn iiCanada,
iithis iiis iithe iiHealth iiProducts iiand iiFood iiBranch, iiand iiin iithe iiU.S.A., iiit iiis iithe iiFood
iiand iiDrug iiAdministration ii(F iiD iiA).
Drug iitesting,, iiMethodology ii- iiAnswers ii-The iimethodology iiof iithe iiproposed iiclinical
iitrial iiin iihumans iiis iirequired.
Drug iitesting,, iiInvestigation ii- iiAnswers ii-The iisubmission iiis iievaluated iiby iiqualified
iiscientists iiin iithe iiregulatory iiagency. iiIf iithey iiare iisatisfied iiwith iithe iisubmission,
iipermission iiwill iibe iigiven iifor iihighly iiqualified iiinvestigators, iiusually iiclinical
iipharmacologists, iito iibegin iiinvestigation iiof iithe iidrug iiin iihumans. iiParticular iicare iiis
iitaken iisince iianimal iistudies iiwill iinot iialways iipredict iidrug iibehaviour iiin iihumans
iiregardless iiof iihow iicarefully iithe iistudies iiare iiconducted.
Clinical iiTrials: iiPhase ii1, ii2, iiand ii3 ii- iiAnswers ii-Once iithe iiinitial iisteps iiare iicomplete
iiand iipermission iiis iigranted, iithe iimanufacturer iican iibegin iiclinical iitrials. iiClinical iitrials
iiare iistudies iiperformed iion iihumans. iiThe iithree iitypes iiof iiclinical iitrials iiare: iiphase ii1,
ii2, iiand ii3.
Note iithat iigenerally, iifor iia iicertain iidrug iitarget, iianywhere iifrom ii5 iito ii30 iicompounds
iimake iiit iithrough iipreclinical iitesting iiand iiinto iiclinical iitrials. iiHowever, iimany iiof iithese
iidrugs iiwill iifail iiphase ii1 iior iiphase ii2 iiclinical iitrials. iiAs iisuch, ii- iiAnswers ii-usually iionly
iione iior iitwo iiof iithose iidrugs iiwill iimake iiit iito iiphase ii3 iiclinical iitrials.
Phase ii1 iiClinical iiTrials ii- iiAnswers ii-Phase ii1 iiclinical iitrials iicarefully iievaluate iithe
iiabsorption, iidistribution, iielimination, iiand iiadverse iieffects iiof iithe iinew iidrug. iiThese
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