term test 1 Flashcards
Definition of a drug
Any EXOGENOUS substance that ALTERS BODY FUNCTION when introduced INTO a living organism.
What makes a substance, like insulin, become regulated as drug? (health canada)
If it is injected into the body.
Sources of drugs and which is the most common nowadays?
Natural preparations, pure compounds, semi-synthetic compounds, biological compounds and
PURELY SYNTHETIC COMPOUNDS
What is the magic bullet theory and who discovered it?
Paul Ehrlich - the drug goes to a particular place in the body
What does the drug development process in Canada consist of?
Preclinical studies, clinical studies with 3 phases, regulatory review, and post-marketing phases.
Takes several years
What are the phases of clinical studies?
Phase I - healthy volunteers to determine safety and dosing range
II - patients to determine safety, efficacy, dosing
III - wide scale, safety and efficacy
What are the different ways of naming drugs during early development?
- Chemical name - describes chemical structure, worldwide, can be more than one name
- Drug Company Code Name - usually only used during marketing phase
What are the ways of naming promising drugs?
- Non-Proprietary name (generic) - the official name if in pharmacopoeias or if not yet, approved name
- Proprietary (brand) - assigned by manufacturer, trademark
- Street name - assigned by public but useful for physician to know
Why are non-proprietary names so complex?
Safety - named to be very different from others
Marketing - encourages people to use brand names
What is Pharmacokinetics?
What the body does to the drug ie. absorption, distribution, metabolism, and exertion
ADME
What is Pharmacodynamics?
What the drug does to the body - action/effects of the drug
Describe the elimination portion of the concentration versus time graph.
A constant PROPORTION is eliminated over time.
At what point in the time course of drug action is an effect seen?
There is a lag due to absorption and then the therapeutic window is between the minimal therapeutic effect and threshold for toxic effects (adverse effects). Below this point there’s no effect.
Why aren’t drugs absorbed in the stomach?
The environment is too harsh (acidity and enzymes), many drugs have a coat to protect from this.
Instead they’re absorbed in the small intestine.
What is the pharmacopeia?
A compilation of officially recognized standards of name, purity, potency, and preparation of drugs.