Pharmacology 2060A/B Lecture : Module 1 Notes.docx
Document Summary
Pharmacology = study of drugs: how drug delivered (route of administration, how drug works, therapeutic effect and adverse effect. Thereaputics: drugs traditional (chemical, biologics antibodies (hormones, natural heath products (herbals, vitamins, minerals) Food and drug act & regulations health canada health canada products. & food branch (3 directorates) therapeutic products/biologics & genetic therapies/natural health products (approves and evaluates) Generic name (unique) pharmacologists use generic name. Trade name (manyassigned by company that makes drug) Approval takes 15 years, cost can be as high as 800 million $ Drug discovery/preclinical testing: in cultured cells, living tissue or animals, evaluate: biological effects, toxicity and pharmacokinetics. Submitted to health canada (before human studies) Lots of paperwork (all pre-clinical trial data) Phase 1 (1 year: 20-100 healthy volunteers, evaluation of pharmacokinetics and pharmacodynamics. Phase ii (2 years: 300-500 with target disorder, evaluation of effectiveness, side effects and dosing. Phase iii (4 years: 500-5000 patients with target disorder, evaluation of effectiveness and long term side effects.