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Pharmacology 2060A/B
Angela Nissen

Pharmacology Module 1Pharmacologystudy of drugs o How drug delivered route of administration o How drug workso Therapeutic effect and adverse effectThereaputics o Drugstraditional chemical o Biologicsantibodies hormones o Natural heath products herbals vitamins mineralsCanadian Drug LegislationFood and drug actregulationshealth Canadahealth Canada productsfood branch3 DIRECTORATES therapeutic productsbiologicsgenetic therapiesnatural health products APPROVES AND EVALUATESWhat is a drug Chemical entityChemical Name chemGeneric Name unique PHARMACOLOGISTS USE GENERIC NAMETrade Name manyassigned by company that makes drugDrug Development Approval takes 15 years cost can be as high as 800 millionFIRST STEP 65 YEARSDrug discoverypreclinical testing o In cultured cells living tissue or animals o Evaluate biological effects toxicity and pharmacokinetics SECOND STEPClinical trial applicationSubmitted to Health Canada BEFORE HUMAN STUDIESLots of paperwork all preclinical trial dataRESPONSE WITHIN 30 daysTHIRD STEPPHASE 1 1 YEAR o 20100 healthy volunteerso evaluation of pharmacokinetics and pharmacodynamicsPHASE II 2 YEARS o 300500 WITH target disorder o evaluation of effectiveness side effects and dosingPHASE III 4 YEARS o 5005000 patients WITH target disorder o evaluation of effectiveness and LONG term side effects
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