Canadian Drug Legislation: Food and Drugs Act & regulation ? Health Canada ? Health Canada Products & Food branch ? Classification of therapeutics: Drugs (therapeutic products) Traditional drugs (chemical agents): Pills and tablets etc… Biologics & Genetic therapies Antibodies, Hormones Natural Health Products Herbals, vitamins, minerals Drugs are chemicals, within every pill are many molecules of a chemical, and its these chemicals that actually produce the pharmacological effect. Drugs have three types of names:
1) Chemical Name – Describes the chemical structure of the molecule. (Chemists) 2) Generic Name – A unique name that identifies a drug. (Pharmacology) Name that should be used by health care professionals. 3) Trade – The name assigned by a drug company. Major problem is many companies may make the same drug, therefore it may have many different trade names.
Marketing Drugs in Canada 1) Preclinical Testing In cultured cells, living tissue or experimental animals Evaluate biological effect, pharmacokinetics, and toxicity (~6.5y) 2) Clinical trail Application Must be submitted to health Canada prior to any human studies Lots of pre-clinical data, paperwork , response within 30 days 3) Phase I clinical trial 20-100 health volunteers (~1y) Evaluation of pharmacokinetics and pharmacodynamics 4) Phase II clinical trial 300-500 patients with the target disorder (~2y) Therapeutic effectiveness, side effects and dosing information is gathered 5) Phase III Clinical Trial 500 – 5000 patients with target disorder (~4y).
Therapeutic effectiveness verified, long term side effects assessed. 6) New Drug Submission (NDS) submitted to Health Canada A report detailing therapeutic effectiveness and safety, including results from preclinical and clinical studies (~1. 5y) If approved Health Canada issues a Notice of Compliance (NOC) and a Drug Information Number (DIN), which are both required to market the drug 7) Phase IV Clinical Trial Post-marketing surveillance ? monitors efficacy and safety after it has been marketed (can be pulled off the market) Can take approx.
15 years, as it moves through several different levels of development and total cost can be as high as 800 million Pharmacokinetics is what the body does to the drug. Absorption, Distribution, Metabolism, and Excretion (ADME) In term of Oral administration:
The drug enters into the Stomach/Small intestines and gets absorbed through the Portal Vein to the liver (primary site of drug metabolism in body) where it gets metabolized and can either be Distributed to systemic circulation to reach target tissues (i.e. heart, brain, muscle, Renal Excretion [Primary excretion organ in body by bladder? urine]) or undergo Biliary Excretion to the Gall Bladder/
Common Bile duct (drugs that enter here usually have large MW or undergo some type of metabolism) and heading back to the small intestines where it will end up being excreted within feces. Routes of Administration: Enteral Parenteral Other Oral (PO) Intravenous (IV) ? Blood System.