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the science of chemicals that effect a living process
toxicology is -
adverse effects of chemicals
drug therapy -
" management" of disease with a medication
a DRUG does what -
alters an effect already existing in a quantitative manner of changes
chemical name for a medication
trade name -
a manufacture's name for the generic product
over the counter (otc) -
legend drug -
behind the counter (btc) -
a non prescriptive drug that requires you to ask for it at the pharmacy, they keep track of how often someone gets that drug.
controlled substance -
prescriptive agent that has the potential for abuse, all are prescriptive drugs.
bioavailable / bioequivalent -
generic medications that have been determined to be equivalent
are two medications given together that produce an effect equal to the sum of the effects of each agent
two medications given together that produce an effect much greater than the sum of the effects of each agent
is when two medications given together, but only one of the agents possess the required action, but that action is enhanced by the second agent.
is an agent that stimulates a receptor
is an agent that blocks a receptor from being stimulated
what are the two pieces of legislation
1938 food and drug cosmetic act - must prove safety (not effectiveness)
1962 kefaver-harris amendment - must prove efficacy / grandfather clause
investigational new drug (IND) procedure
what is it required for -
- - chemical or substance not previously used in humans
- - new combination not used in combination before
- - new use for a previously issued drug
- - new dosage form
investigational phases (4)
name and describe -
- phase 1 - determine safety and tolerated dose in a few "healthy" volunteers
- phase 2 - determine safety, efficacy and pharmacokinetics in selected "diseased" individuals
- phase 3 - determine safety and efficacy in widespread study
- phase 4 - drug marketed with surveillance
name 2 types of studies -
double blind - neither the patient nor the doctor know if the patient is taking the drug or a plecebo
single blind - doctor knows who is being tested or not, they can affect the outcome of the study.
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