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