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31 Cards in this Set

  • Front
  • Back
What are pharmacoodynamics?
actions of a drug on the body involving receptor binding, post-receptor effects and chemical interactions
What are pharmacokinetics?
actions of the body on a drug, eg) absorption, distribution, metabolism and excretion
Is a tylenol capsule a drug?
no, the 500mg of acetaminophen inside the capsule is the drug, the rest is composed of excipients, solvents and junk
What are excipients?
the bulk of a pill used to bind, dissolve, carry, flavor and color
A ________ name characterizes the atomic or molecular structure of a drug
chemical
a drug has only one _______ name, which is public property
generic
Amoxil is an example of a _______ name
trade
oxycodone is an example of a ___________ name.
generic
Rx drugs are deemed unsafe without medical supervision (true/false)
true
OTC drugs are deemed safe to use without medical supervision because they lack toxicity (true/false)
false (they are still potentially toxic, but are proven to be safer for self-medication)
What is an Orphan Drug?
a drug that targets a disease affecting less than 200,000 people
What are the incentives for drug companies to develop orphan drugs?
tax rewards and marketing exclusivity
What are the three criteria for establishing a specific drug's "schedule"
medical use, abuse potential, dependence potential
under what drug schedule is LSD?
I
under what schedule is tylenol?
V
Under what schedule is zolpidem (Ambien)?
Schedule IV
Under what schedule is morphine?
II
anabolic steroids fall under what drug schedule?
III
The safety and efficacy of dietary supplements must be reviewed by the FDA before they are marketed (true/false)
false (FDA only takes action after a supplement has been proven harmful)
What distinguishes a drug from a dietary supplement?
intended use (drugs intended to treat a disease. supplements cannot make such claims)
what are the three categories of health claims allowed on a supplement label and which category has the most stringent FDA requirements?
nutrient claims, health claims (most stringent), structure-function claims
Apprx how much does it cost to develop a new drug, how long, and what are most of the costs attributed to?
new drug costs apprx $1billion, 8-12 years, 75% costs attributed to failure during development
apprx what percentage of drugs make it to market?
10%
Phase I clinical trials are about testing ______ and _________
safety and pharmacokinetics
Phase one trials are conducted on healthy individuals (true/false)
true
Phase II trials are designed to address __________ and ___________
safety and efficacy
Phase II clinical trials are performed on patients with the disease being targeted (true/false)
true
Phase ____ trials are known as "Pivotal" studies
III
When is the "New Drug Application" filed?
between Phase III and IV clinical trials
What is the purpose of Phase IV trials?
test for long-term side effects, revise uses, include restrictions
Physicians are legally bound to use drugs for the indications listed on their labels (true/false)
false