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Lecture 8

Lecture 8 - Drug Development.pdf

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Department
Pharmacology
Course
Pharmacology 4350A/B
Professor
Rommel Tirona
Semester
Winter

Description
RECEPTORS TISSUE RESERVOIR Bound Free Bound Free DISTRIBUTION DRUG EFFECT Drug dose APSORPTION Free Drug EXCRETION Systemic Circulation Bound Metabolites drug METABOLISM RECEPTORS TISSUE RESERVOIR Bound Free Bound Free DISTRIBUTION DRUG EFFECT Drug dose APSORPTION Free Drug EXCRETION Systemic Circulation Bound Metabolites drug METABOLISM Lecture8 - DrugDevelopment April-21-12 9:46 AM Drugdevelopment - 11% successfullymakeittoregistrationstage - Purposeofclinicaltrial ○ Drugsafety+sideeffects+therapeuticwindow+market(lifelongpreventiveortreatment) (price) - Phase1 ○ Challenges:ethicsboardapproval+developnetworkofclinicalinvestigators/patients ○ Objective:OnHealthyindividuals+specialpopulation 1. DeterminecommonADR 2. Determinedosewithouthighincidenceofsideeffects 3. DeterminepharmacokineticADME 4. IntrinsicEffectonspecialpopulation(renal/hepaticfailure+preg+age +sex/race) 5. Extrinsiceffect(drug/druginteraction+drug/foodinteraction) ○ Method:  Uncontrolledclinicaltrials(esclatingsingledoses+recurrentdoses)  Determinepharmacokinetics □ Descriptiveobservation(measureddrugCONC)+prediction(mathematicalmodel)+ Mechanistictheory(molecularbiology) □ PKdeterminesifdevelopmentcontinues+determinefinancialinfo(routeofintake+ frequencyofintake) ○ Example  TGN1412= monoclonalantibodyCD28(treatautoimmunedisease) □ Phase1trialcontracted toParaxel  6healthyvolunteers+2placebo  Developedintensesystemicinflammatorythatledtoorganfailure+criticalill □ Paraxeldosed6subjectssimultaneouslywhentheyshould'vedosed1beforedosing all6  50% ofvolunteersarenotprovidedwithfreehealthcarefromclinicaltrial - Phase2 ○ Challenges:Ethicsapproval+developnetworkofclinicalinvestigators/patients ○ Objective:Patients Phase2- broad endpointstolookat everything 1. DeterminetherapeuticefficacyinPATIENTSofinterest Phase3- narrow endpointsandmoreclinicalendpoints 2. Determineexperimentalprotocolsforphase3(dose+duration+right endpointsto measure) Problemswithendpointassessment ○ Methods: - Unpredictablefactors  Onpatientswithdiseaseofinterestusuallyexcludingspecialpopulations □ Verynarrowrangeofselection ○ Someillnesshealonitsown+illnesscomesinwaves  Placebo-controlledtrial ○ Conditionofpatient(oldageleadstoMI/strokemorethananything)
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