answers
What is a drug - ✅✅Chemical agent capable of producing biological responses
in the body
Desirable drug response - ✅✅Therapeutic effect
Undesirable drug response - ✅✅adverse effect
A drug that is considered medically therapeutic is referred to as what -
✅✅Medication
What are biologics - ✅✅agents naturally produced in animal cells, by
microorganisms, or by the body itself (vaccines, hormones, monoclonal
antibodies)
Natural health products (NHP) - ✅✅variety of products such as herbal
medicines, homeopathic remedies and nutritional supplements.
- must know if patient is on these to avoid double dosing or interference of meds
HPFB - ✅✅Health Products and Food Branch
- protects Canadians by reducing health risks and ensuring safety of health
products
,Pharmacotherapy - ✅✅the administration of drugs for disease prevention or
treatment of suffering
Pharmacokinetics - ✅✅How medication gets moved, absorbed, distributed,
broken down, metabolized, excreted
Pharmacodynamics - ✅✅How drug does its thing, dose you need for an effect
Toxicology - ✅✅When the drug becomes toxic and creates adverse effects
(different than side effects)
Indication - ✅✅The conditions for which a drug is approved
Therapeutic Classification - ✅✅Organizes drugs based on their therapeutic
usefulness in treating disease (Anticoagulant, Antihypertensive)
Pharmacological Classification - ✅✅Describes how the drug works at the
molecular, tissue, and body system level (Vasodilator, Calcium channel blocker,
etc)
Mechanisms of Action - ✅✅How a drug produces its effect on the body
The ideal drug... - ✅✅Is safe, effective, and produces a rapid, predictable
response at a relatively low doses
,Steps of approval for drugs marketed in Canada - ✅✅1. Initial drug research is
conducted
2. Preclinical studies in cultured cells, living tissue, and species of animals
3. Phase 1, Phase 2, Phase 3
4. Pharm company completes a New Drug Submission to Health Canada
5. Committee of experts review NDS
6. Health Canada reviews info on drug and passes info to providers and
consumers
7. Health Canada issues a Notice of Compliance and Drug Identification Number
8, Health Canada monitors efficacy of drug and safety concerns
9. Pricing regulated
Phase 1 Clinical trials - ✅✅(Safety Phase) Drug is tested on a small group of
healthy humans
- Looking at pharmokinetics and dynamics in humans
Phase 2 Clinical Trials - ✅✅(Effectiveness Phase) Drug is tested on small group
of humans with target disorder
Phase 3 Clinical Trials - ✅✅(Confirmation Phase) Larger groups of patients with
the target disorder
Phase 4 Clinical Trials - ✅✅(Monitoring Phase) After the drug is approved and
in market, more info is gathered on use, benefits, and risks
, What type of trials are these clinical trials typically - ✅✅These clinical trials are
typically a blind or double blind study to avoid any biases or placebo effects.
Chemical drug name - ✅✅Drugs named after chemical composition
Generic drug name - ✅✅Assigned international non-proprietary name.
Describes active ingredient
- makes it best to recognize
(Ibuprofen)
Brand/Trade drug name - ✅✅Name selected by the manufacturing company
(advil, aleve, motrin) Proprietary name
Different non-active ingredients and bioavailability - ✅✅Despite the same
active chemical, the different non-active ingredients in different brands of the
same drug may affect the efficacy due to bioavailability
Bioavailability - ✅✅Amount of drug that is absorbed into the systematic
circulation and is physiologically available to reach target cells and produce an
effect
What is a prototype drug - ✅✅the well-understood drug model with which
other drugs in its representative class are compared
What are prototype drugs used for - ✅✅Serves as a model example for its drug
class because its mechanism of actions, side effects, and uses are well understood