NURS 316
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1. Pharmacology The study of medicines (Pharmakon)that includes: indication, administration,
transport around the body, responses produced
2. Pharmacothera- Administration of drugs for the purpose of disease prevention or treatment and
peutics relief of suffering.
3. Physiology Normal function of the body
4. Pathophysiology Abnormal changes caused by (or resulting in) disease
5. Pharmacodynam- What a drug does to the body
ics
6. Pharmacokinet- What the body does to the drug
ics
7. Drug chemical agent capable of producing biologic responses within the body
8. Therapeutic ef- Desirable response
fect
9. Adverse effect Undesirable response
10. Biologics Agents naturally produced in Aminal cells, used to treat and prevent various
illnesses
11. Natural health Naturally occurring health substances used to maintain or restore health
products (NHP)
12. Drug Regulation Health Products and Food Branch (HPFB) of Health Canada has a mandate to
"maximize the safety provided by the regulatory system for health products and
food"
Canadian federal drug legislation requires the drug manufacturer to prove that a
drug is both safe and effective for a specified purpose
, NURS 316
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13. Drug regulations safe and effective
require that a
drug be what for
a specific pur-
pose?
14. Step 1 for ap- Initial drug research is conducted
proval of drugs
15. Step 2 for ap- Preclinical studies in cultured cells, living tissue, and species of animals are
proval of drugs performed
16. Step 3 Phase I Safety phase: small group of healthy humans
17. Step 3 Phase II The effective phase: small group of humans with the target disorder
18. Step 3 Phase III The confirmation phase: larger groups of patients with the target disorder. Double
blind study. Only 10% make it to phase III
19. Step 3 Phase IV Ongoing research
20. Step 4 for ap- The pharmaceutical company completes a New Drug Submission (NDS) to Health
proval of drugs Canada. This report details important safety and efficacy information, including
testing data how the drug product will be produced and packaged, expected
therapeutic benefits, and adverse reactions.
21. Step 5 for ap- A committee of drug experts including medical and drug scientists, reviews the
proval of drugs NDS to identify protection drug benefits and risks.
22. Step 6 for ap- Health Canada reviews information about the drug product and passes on impor-
proval of drugs tant details to healthcare provider and consumers
23. Step 7 for ap- Health Canada issues a Notice of Compliance (NOC) and Drug Identification
proval of drugs number (DIN). Both are required for the manufacturer to market the drug product
, NURS 316
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24. Step 8 for ap- Heath Canada monitors the efficacy of the drug and any safety concerns after it
proval of drugs has been marketed. This is done by regular inspection, notices, newsletters, and
feedback from consumers and healthcare provider.
25. Pricing and Ac- The Patented Medicine Prices Review Board (PMPRB) operates independent of
cess to Prescrip- Health Canada, to regulate the prices charged by manufacturers for patented
tion medicines to ensure they are not excessive
26. Medication drug that is considered medically therapeutic is commonly referred
27. Drug regulations safe and effective
requires that a
drug be what for
a specific pur-
pose?
28. Drug indication intended or indicated uses for any drug
29. Mechanism of how a drug produces its physiological effect in the body
Action
30. 2 drugs having ideal drug produces a rapid, predictable response at a relatively low doses
the same effect,
but at different
doses, which one
is more effective?
31. Therapeutic clas- Organizes drugs based on their therapeutic usefulness in treating a disease.
sification of a
drug
32. Describes how the drug works at the molecular, tissue, and body system level
Study online at https://quizlet.com/_hx7nw9
1. Pharmacology The study of medicines (Pharmakon)that includes: indication, administration,
transport around the body, responses produced
2. Pharmacothera- Administration of drugs for the purpose of disease prevention or treatment and
peutics relief of suffering.
3. Physiology Normal function of the body
4. Pathophysiology Abnormal changes caused by (or resulting in) disease
5. Pharmacodynam- What a drug does to the body
ics
6. Pharmacokinet- What the body does to the drug
ics
7. Drug chemical agent capable of producing biologic responses within the body
8. Therapeutic ef- Desirable response
fect
9. Adverse effect Undesirable response
10. Biologics Agents naturally produced in Aminal cells, used to treat and prevent various
illnesses
11. Natural health Naturally occurring health substances used to maintain or restore health
products (NHP)
12. Drug Regulation Health Products and Food Branch (HPFB) of Health Canada has a mandate to
"maximize the safety provided by the regulatory system for health products and
food"
Canadian federal drug legislation requires the drug manufacturer to prove that a
drug is both safe and effective for a specified purpose
, NURS 316
Study online at https://quizlet.com/_hx7nw9
13. Drug regulations safe and effective
require that a
drug be what for
a specific pur-
pose?
14. Step 1 for ap- Initial drug research is conducted
proval of drugs
15. Step 2 for ap- Preclinical studies in cultured cells, living tissue, and species of animals are
proval of drugs performed
16. Step 3 Phase I Safety phase: small group of healthy humans
17. Step 3 Phase II The effective phase: small group of humans with the target disorder
18. Step 3 Phase III The confirmation phase: larger groups of patients with the target disorder. Double
blind study. Only 10% make it to phase III
19. Step 3 Phase IV Ongoing research
20. Step 4 for ap- The pharmaceutical company completes a New Drug Submission (NDS) to Health
proval of drugs Canada. This report details important safety and efficacy information, including
testing data how the drug product will be produced and packaged, expected
therapeutic benefits, and adverse reactions.
21. Step 5 for ap- A committee of drug experts including medical and drug scientists, reviews the
proval of drugs NDS to identify protection drug benefits and risks.
22. Step 6 for ap- Health Canada reviews information about the drug product and passes on impor-
proval of drugs tant details to healthcare provider and consumers
23. Step 7 for ap- Health Canada issues a Notice of Compliance (NOC) and Drug Identification
proval of drugs number (DIN). Both are required for the manufacturer to market the drug product
, NURS 316
Study online at https://quizlet.com/_hx7nw9
24. Step 8 for ap- Heath Canada monitors the efficacy of the drug and any safety concerns after it
proval of drugs has been marketed. This is done by regular inspection, notices, newsletters, and
feedback from consumers and healthcare provider.
25. Pricing and Ac- The Patented Medicine Prices Review Board (PMPRB) operates independent of
cess to Prescrip- Health Canada, to regulate the prices charged by manufacturers for patented
tion medicines to ensure they are not excessive
26. Medication drug that is considered medically therapeutic is commonly referred
27. Drug regulations safe and effective
requires that a
drug be what for
a specific pur-
pose?
28. Drug indication intended or indicated uses for any drug
29. Mechanism of how a drug produces its physiological effect in the body
Action
30. 2 drugs having ideal drug produces a rapid, predictable response at a relatively low doses
the same effect,
but at different
doses, which one
is more effective?
31. Therapeutic clas- Organizes drugs based on their therapeutic usefulness in treating a disease.
sification of a
drug
32. Describes how the drug works at the molecular, tissue, and body system level
