Pharmacology part 1: Final Flashcards
What are chemical names
state the chemical structure or chemical classification
what are generic names
shortened version of chemical
what are trade names
brand names
i.e. tyelenol
pts form recognition of the name
What are generic equivalents
drugs that are marketed by generic names after the patent has expired
less expensive than trade names
what are the stages of FDA testing/approval
1 - preclinical (animal trials); 1-2 years
2 - clinical trials; 3 phases; ~5-6 years total
3- approved for market; market studies/feedback
what are the 3 phases of the clinical trial for the FDA testing
phase 1 = healthy volunteers to test side effects
phase 2 = small pt sample (200-300) to test effectiveness of drug for treatment
phase 3 = larger sample; few thousand; determine of drug is safe for larger population
what are pharmocokinetics
what the body does to the drug
how is it absorbed, metabolized, excreted, etc
what are pharmacodynamics
what the drug does to the body
i.e. how it lowers pain, BP, motor fxn, etc
what is expedited review
if a drug has exceptional need or beneficial effects
saves time
drug is used in general population before clinical trials and testing continues after drug is already in use
what are orphan drugs
drugs indicated for a very small population
FDA subsidizes companies to fund production of drugs
what is off label prescribing
hasnt been approved by FDA for condition other than it’s original purpose
BUT if a doctor sees a benefit that is not the original purpose of the drug they can still prescribe that medicine because the FDA is not allowed to tell doctor’s how to practice medicine
what are the implications of drug testing/approval
-cost of the drug
-whether it is available in the US and/or other countries
-failure to identify serious side effects
describe the dose response concept
if the dose is too low = no response
threshold dose = when you first start seeing results from drug
too high and you reach the ceiling effect (no more added benefit of more drugs)
curve contains a therapeutic range where benefits are most advantageous to pt
what is drug potency
related to dose that causes specific response in a specific magnitude
i.e. comparing 2 drugs; the one that causes a response at a lower dose is the more potent drug compared to the one that requires a higher dose for the same response
how do you find the therapeutic index and what is the significance
TI = TD50 (median toxic dose) / ED50 (median effective dose)
higher the TI the safer the drug
there is no cut off point
