Part 1 Pharmacology Flashcards
what is pharmacology broken down into?
pharmacotherapeutics & toxicology
what is pharmacokinetics?
what body does to drug
what is pharmacodynamics?
what does drug do to body
what are the three names drugs are identified as?
generic
chemical
trademark
a drugs ____ name is usually shortened to a form the drugs _____ name?
chemical to form generic
what is a generic equivalent?
drug marketed by generic name after the patent has expired
generic forms typical less expensive than brand name products
how is a generic equivalent “bioequivalent” to a brand name?
- same type & amount of active ingredient
- uses same administration route
- same pharmacokinetic profile
- found to have same therapeutic effects
what is the role of the FDA in drug approval?
-government agency oversees drug testing/approval
-responsible for drug classification
what is the phases of drug testing?
Preclincals
Clinical trials
Phase 1 (healthy volunteers)
Phase 2 (small patient sample)
Phase 3 (larger sample)
Approved for marketing
Phase 4 (post marketing surveillance)
how can a drug get an expedited review?
if the drug has exceptional need or beneficial effects, requested by drug company
what is an orphan drug?
certain drugs are only indicated for small populations
FDA arranges funding from additional sources to subsidize drug development
what are some implications of drug testing/approval?
drug costs
availability in USA vs other countries
failures to identify serious side effects
what is off-labeling prescribing?
prescription of a drug for a purpose that has not been approved by FDA
what is the dose-response relationship?
if dose is too low no response
-response will start to appear at some “threshold dose”
-in theory the response increases as the dose increases
what happens to the response once the dose hits a certain point?
response can plateau which is called maximal efficacy or ceiling effect