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Western University
Pharmacology 2060A/B
Angela Nissen

Module 1 Pharmacology – study of drugs ­ pharmakon – remedy ­ logos – study ­ studying drugs o how a drug is delivered (route of administration)  enteral • oral and rectal (involving GI tract)  parenteral • intravenous, intramuscular, subcutaneous • being injected into patient o into blood, muscle, or under skin  Topical • Creams and patches o how a drug works (mechanism of action) o therapeutic effect on patients o adverse effects on patients Clarification of Therapeutics  ­ drugs o traditional drugs (chemical agents) ­ biologics o antibodies ­ natural health products o herbal, vitamins, minerals Canadian Drug Legislation   ­ therapeutic products directorate – approves and evaluates traditional drugs ­ same with the other directorates for biologics and natural health products What is a Drug? ­ Actual chemicals ­ Within every pill are molecules of a chemical ­ Which produces the pharmacological effect Naming Drugs  ­ Three types of names o Chemical name: describes chemical structure, used by chemists o Generic name: unique name that identifies the drug  Most often used in pharmacology  Name that should be used by health care professionals o Trade name: name assigned by drug company  Usually easy to remember, and marketable  Many companies make the same drug, therefore one drug can have  many trade names ­ ­ Chemical name: 7-chloro-1,3-dihydro-1-methyl-5-phenyl-1,4- benzodiazepin-2(2H)-one ­ Generic name: Diazepam ­ Trade name(s): Valium......................and ­ Alboral; Aliseum; Alupram; Amiprol; An-Ding; Ansiolin; Ansiolisina; Apaurin; Apo-Diazepam; Apozepam; Armonil; Assival; Diazemuls; Diazemulus; Diazepam Intensol; Diazepan; Diazetard; Dienpax; Dipam; Dipezona; Dizac; Domalium; Duksen;am; Diastat; Duxen; E-Pam; Eridan; Eurosan; Evacalm; Faustan; Faustan,; Freudal; Frustan; Gewacalm; Gihitan; Kabivitrum; Kiatrium; LA III; La-Iii; Lamra; Lembrol; Levium; Liberetas; Mandrozep; Morosan; Neurolytril; Noan; Novazam; Novo-Dipam; Paceum; Relaminal; Relanium; Renborin; Ruhsitus; Saromet; Sedapam; Sedipam; Seduksen; Seduxen; Serenack; Serenamin; Serenzin;; Servizepam; Setonil; Sibazon; Sibazone; Solis; Sonacon; Stesolid; Stesolin; Tensopam; Tranimul; Tranqdyn; Tranquase; Tranquirit; Tranquo-Puren; Tranquo-Tablinen; Umbrium; Unisedil; Usempax Ap; Valaxona; Valeo; Valiquid; Valitran; Valium; Valrelease; Vatran; Velium; Vival; Vivol; Zetran; Zipan   Approval of Marketed Drugs in Canada   ­ Drug development o Approval takes approximately 15 years  Several levels o Total cost can be up to 800 million dollars ­ Drug discovery and preclinical testing o In cultured cells, living tissue, experimental animals o Evaluate biological effects, pharmacokinetics, and toxicity o Approximately 6.5 years ­ Clinical trial application o Must be submitted to health Canada prior to human studies o Lots of paperwork and pre­clinical data o Responds within 30 days of receipt ­ Phase I clinical trial o 20­100 healthy volunteers o evaluation of pharmacokinetics and pharmacodynamics o approximately 1 year ­ Phase II clinical trial o 300­500 patients with target disorder o therapeutic effectiveness, side effects and dosing information gathered o approximately 2 years ­ Phase III clinical trials o 500­5000 patients with target disorder o therapeutic effectiveness verified, long term side effects assessed o approximately 4 years ­ New Drug Submission (NDS) to health Canada o Report with details for therapeutic effectiveness and safety o Preclinical and clinical studies o If approved, health Canada issues a Notice of Compliance (NOC) and a  Drug Identification Number (DIN)   Both are required to market the drug o Approximately 1.5 years ­ Phase IV clinical trial o Post marketing surveillance o Health Canada monitors the efficacy of drugs o Can be removed off the market o Ex. Viox o Continues long after the drug has been marketed Pharmacokinetics  ­ What the body does to the drug ­ Encompasses: o Absorption o Distribution o Metabolism  Carried to liver (primary drug metabolism in body) o Excretion  Kidney is primary excretion organ  Or bile (leave through feces) Basic Physiology and the Cell Membrane  ­ Physiological Barriers to Drug Transport o P
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