PAT 201 CH.1-4 EXAM QUESTIONS WITH CORRECT
ANSWERS
Pharmacotherapy
the application of drugs for the purpose of disease prevention and treatment of
| | | | | | | | | | | | |
suffering
Therapeutic agents may be classified as
| | | | |
Traditional drugs, biologics, natural health products
| | | | |
Biologics
agents naturally produced in animal cells, by microorganisms, or by the body
| | | | | | | | | | | |
itself.
Examples: hormones, monoclonal antibodies, natural blood products,vaccines,
| | | | | | |
interferon
Natural Health Products (NHP)
| | |
variety of products such as herbal medicines, homeopathic remedies and
| | | | | | | | | |
nutritional supplements.
|
,How many steps are there for the approval of drugs in Canada
| | | | | | | | | | |
8 steps
|
STEP 1 DRUG APPROVAL PROCESS
| | | |
Initial drug research is conducted (no trials yet)
| | | | | | |
Step 2 of drug approval process
| | | | |
Pre clinical trials- cultured cells, tissues, animals (no human testing yet)
| | | | | | | | | |
Step 3 of drug approval process
| | | | |
Once clinical trials (human testing) they proceed 4 phases once application is
| | | | | | | | | | | |
approved by Health Canada | | |
Step 3 of Phase 1
| | | |
SAFETY PHASE: small group of healthy humans
| | | | | |
Step 3 of Phase 2
| | | |
EFFECTIVENESS PHASE: small group of humans with the target disorder
| | | | | | | | |
,Step 3 of Phase 3
| | | |
CONFIRMATION PHASE: larger groups of patients with the target disorder
| | | | | | | | |
Step 3 of Phase 4
| | | |
MONITORING PHASE: after the drug is approved and in the market, more
| | | | | | | | | | | |
information gathered |
Step 4 of drug approval process
| | | | |
The pharmaceutical company completes a New Drug Submission (NDS) to Health
| | | | | | | | | | |
Canada. This report details important safety and efficacy information, including
| | | | | | | | | |
testing data, how the drug product will be pronounced and packaged, expected
| | | | | | | | | | | |
therapeutic benefits, and adverse reaction
| | | |
Step 5 of the drug approval process
| | | | | |
A committee of drug experts, including medical and drug scientists, reviews the
| | | | | | | | | | | |
NDS to identify potential drug benefits and risks
| | | | | | |
Step 6 of the drug approval process
| | | | | |
, Health Canada reviews information about the drug and passes on details to
| | | | | | | | | | | |
healthcare provider and consumers| | |
Step 7 of drug approval process
| | | | |
Health Canada issues a Notice of Compliance and Drug Identification Number.
| | | | | | | | | | |
Manufacturer must have these to market the drug
| | | | | | |
Step 8 of Drug approval process
| | | | |
Health Canada continues to monitor the drug after marketing
| | | | | | | |
Therapeutic classification |
describes what is being treated by the drug
| | | | | | |
-isn't as complicated
| |
- clearly state what a drug does clinically
| | | | | | |
(E.g. elevated blood pressure)
| | |
example of therapeutic classification
| | |
Antihypertensive, Anticoagulant |
ANSWERS
Pharmacotherapy
the application of drugs for the purpose of disease prevention and treatment of
| | | | | | | | | | | | |
suffering
Therapeutic agents may be classified as
| | | | |
Traditional drugs, biologics, natural health products
| | | | |
Biologics
agents naturally produced in animal cells, by microorganisms, or by the body
| | | | | | | | | | | |
itself.
Examples: hormones, monoclonal antibodies, natural blood products,vaccines,
| | | | | | |
interferon
Natural Health Products (NHP)
| | |
variety of products such as herbal medicines, homeopathic remedies and
| | | | | | | | | |
nutritional supplements.
|
,How many steps are there for the approval of drugs in Canada
| | | | | | | | | | |
8 steps
|
STEP 1 DRUG APPROVAL PROCESS
| | | |
Initial drug research is conducted (no trials yet)
| | | | | | |
Step 2 of drug approval process
| | | | |
Pre clinical trials- cultured cells, tissues, animals (no human testing yet)
| | | | | | | | | |
Step 3 of drug approval process
| | | | |
Once clinical trials (human testing) they proceed 4 phases once application is
| | | | | | | | | | | |
approved by Health Canada | | |
Step 3 of Phase 1
| | | |
SAFETY PHASE: small group of healthy humans
| | | | | |
Step 3 of Phase 2
| | | |
EFFECTIVENESS PHASE: small group of humans with the target disorder
| | | | | | | | |
,Step 3 of Phase 3
| | | |
CONFIRMATION PHASE: larger groups of patients with the target disorder
| | | | | | | | |
Step 3 of Phase 4
| | | |
MONITORING PHASE: after the drug is approved and in the market, more
| | | | | | | | | | | |
information gathered |
Step 4 of drug approval process
| | | | |
The pharmaceutical company completes a New Drug Submission (NDS) to Health
| | | | | | | | | | |
Canada. This report details important safety and efficacy information, including
| | | | | | | | | |
testing data, how the drug product will be pronounced and packaged, expected
| | | | | | | | | | | |
therapeutic benefits, and adverse reaction
| | | |
Step 5 of the drug approval process
| | | | | |
A committee of drug experts, including medical and drug scientists, reviews the
| | | | | | | | | | | |
NDS to identify potential drug benefits and risks
| | | | | | |
Step 6 of the drug approval process
| | | | | |
, Health Canada reviews information about the drug and passes on details to
| | | | | | | | | | | |
healthcare provider and consumers| | |
Step 7 of drug approval process
| | | | |
Health Canada issues a Notice of Compliance and Drug Identification Number.
| | | | | | | | | | |
Manufacturer must have these to market the drug
| | | | | | |
Step 8 of Drug approval process
| | | | |
Health Canada continues to monitor the drug after marketing
| | | | | | | |
Therapeutic classification |
describes what is being treated by the drug
| | | | | | |
-isn't as complicated
| |
- clearly state what a drug does clinically
| | | | | | |
(E.g. elevated blood pressure)
| | |
example of therapeutic classification
| | |
Antihypertensive, Anticoagulant |
