Class notes PHARM 2060

Pharmacology the study of drugs • How a drug is delivered its route of administration • How a drug works its mechanism of action • The therapeutic effect of drugs on patients • The adverse effects of drugs on patients Classification of therapeutics • Drugs traditional drugs o Chemical agents ▪ pills ▪ capsules ▪ tablets • Biologics recent advances in technology have allowed for these o Antibodies, hormones • Natural health products herbals, vitamins, minerals Canadian Drug Legislation • Therapeutic Products Directorate o involved with the approval of typical drugs • Biologics and Genetic Therapies Directorate o Involved in the approval of hormone and antibody therapies • Natural health products directorate o Involved with the approval of natural drug therapies Drugs have to think of drugs as chemicals • Naming o chemical names generally not used in pharmacology ▪ describes the chemical structure of the molecule ▪ used by chemist o generic names pharmacologist use this name ▪ unique name that identifies a drug ▪ the name that should be used by health care professionals o trade names name assigned by a drug company ▪ easy to remember and marketable ▪ problem many companies may make the same drug therefore it may have many different trade names • Drug development o approval of marketed drugs in Canada takes approx. 15 years o drug development moves through several different levels o the total cost of a new drug can be as high as $800,000,000 o Preclinical testing most extensive and longest step in the process ▪ Can take up to 6.5 years to complete o Clinical trial application involves a lot of paper work detailing all pre-clinical trials ▪ Health Canada responds within 30 days of receipt to allow a clinical trial to proceed o Phase I Clinical trial ▪ Health volunteers used NOT PATIENTS ▪ Takes approx. 1 year to complete o Phase II CT ▪ Conducted in relatively few numbers in patients ▪ Patients monitored to see if they have any side effects ▪ Takes approx. 2 years to complete o Phase III CT ▪ Very important to verify therapeutic effectiveness and monitor patients for long term side effects from the drug ▪ Takes approx. 4 years to complete ▪ Involves a large amount of patients with the target disorder/illness o New Drug Submission (NDS) ▪ After completion of the first 3 clinical trials .........................................COBTINUED.............................................