Module 1 Flashcards
The study of drugs.
Pharmacology
Pharmakon means this.
Remedy
Logos means this
Study (or body of knowledge)
What are the three ways to classify therapeutics?
Drugs - traditional drugs (i.e. chemical agents)
Biologics - antibodies, hormones
Natural health products - herbals, vitamins, minerals
What branch oversees pharmacologic agents in Canada?
Health Canada Products and Food Branch
What are the different directorates of the Health Canada Products and Food Branch?
Therapeutic Products Directorate
Biologics and Genetic Therapies Directorate
Natural Health Products Directorate
Oversees traditional drugs such as pills and capsules.
Therapeutic Products Directorate
Oversees antibody and hormone-type therapeutics
Biologics and Genetic therapies directorate
What are the different ways in which a drug is named?
Trade name
Generic name
Chemical (IUPAC) name
Describes the chemical structure of the molecule. Is used by chemists but not by many others.
Chemical name
A unique name that identifies a drug. Most commonly used in pharmacology. It is the name that should be used by HCPs
Generic name
The name assigned by a drug company, usually easy to remember and marketable.
Trade name
What is the issue with trade names?
The problem with trade names is that many companies may make the same drug, therefore it may have different trade names.
Approval of marketed drugs in Canada takes approximately ___ years.
The total cost of a new drug can be as high as ___________$.
15
800 000 000$
Approval of marketed drugs in Canada goes through many stages. What are they?
Pre-clinical testing and Drug discovery Clinical trial application Phase 1 clinical trial Phase 2 clinical trial Phase 3 clinical trial New drug submission (NDS) submitted to Health Canada Phase IV clinical trial
This step of drug testing/development is done in culture cells, living tissue or experimental animals.
The goal is to evaluate biological effects, pharmacokinetics and toxicity.
Preclinical testing/Drug discovery
This must be submitted to Health Canada prior to any human studies.
Details all pre-clinical data.
Health Canada will respond within ___ days of receipt.
Clinical trial application
30
Involves testing on 20-100 healthy volunteers.
What is evaluated at this stage?
Phase 1 clinical testing
Evaluate pharmacokinetics and pharmacodynamics
Involves testing on 300-500 patients with the target disorder.
What is determined at this stage?
Phase II clinical trial
Therapeutic effectiveness, side effects and dosing information is gathered
Involves testing on 500-5000 patients with the disorder.
What is determined?
Therapeutic effectiveness is verified, long term side effects are assessed
Report detailing the therapeutic effectiveness and safety of the drug.
It includes results from pre-clinical and clinical trials.
New drug submission
If the NDS is approved, what does Health Canada issue?
Notice of Compliance (NOC) and a Drug information number (DIN)
What is needed to market a drug?
NOC and DIN
Notice of Compliance
Drug information number