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18 Cards in this Set
- Front
- Back
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who are the test subjects in pre-clinical studies? what are they mainly testing?
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- animals
- underlying process is safety, pharmacokinetics (absorption, distribution, clearance) |
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phase I studies: volunteers? what is important?
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- in a group of healthy volunteers (20-100), safety & pharmacokinetics still important
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phase II studies: volunteers? What is important?
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- more volunteers (100-500)
- usually in people who have disease - does this drug do what it is supposed to do |
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phase III studies: volunteers? what is important?
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- lots of volunteers (1000-5000)
- randomization - prove that drug is really better than current therapy |
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IND vs. NDA?
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- IND: investigation drug application - contact FDA tell them you're going to investigate - 30 days to hear back from them
- NDA: new drug application - 1.9 million dollars just for application |
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How long is the patent on the drug? and how long does it take to approve the drug?
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- 20 years patent from the day you turn in your first drug discovery
- 12 years to approve usually - therefore usually only have 8 years left of patent |
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to become a generic drug what do you have to prove?
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- just have to prove that drug has same pharmacokinetic properties - don't need to prove safety and efficacy
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can you prescribe a drug for off-label use? can you promote a drug for off-label use?
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- can prescribe it
- cannot promote it |
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what is the risk evaluation & mitigation strategy?
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- if something is toxic you need to start advertising it
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Kefauver-Harris amend
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- in response to thalidomide
- now drugs have to prove their efficacy & ensure safety |
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prescription drug user fee act
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- because it was taking so long to review drug applications
- funds for application used to FDA to support staff to handle the applications |
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dietary supplement health & education act
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- to establish dietary supplements to have a standard b/c previously regulated under food
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What is the difference between Rx drugs & dietary supplements in terms of: safety? labeling? ingredients? potency/purity?
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- safety: Rx deemed safe/effective in humans, supplements considered safe until proven otherwise
- labeling: Rx strict labeling, dietary labeling not allowed to make disease treatment/prevention claims/label may not contain all ingredients - ingredients: Rx drugs have only a few ingredients/pill, dietary typically many active ingredients - potency/purity: Rx ensured, we don't know for supplement |
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primary vs secondary/tertiary literature
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- primary: full text of original
- secondary/tertiary: summary of info about drugs |
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What is the ISI impact factor?
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- # cites in article / # of articles published
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what will you not find about the drug in the secondary/tertiary books?
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- will not find off label use
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what are the different categories for pregnancy risk?
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- Cat A is best
- Cat B is animal studies/human do not show harm - Cat C effects in animals but no available data in women - Cat D is positive evidence of human fetal risk but benefits outweigh risks - Cat X is worst |
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which is the worst - Schedule I - IV?
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- schedule I is the worst
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