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67 Cards in this Set
- Front
- Back
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What law created the FDA?
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Pure Food and Drug Act
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What year was the Pure Food and Drug Act est?
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1906
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The Pure Food and Drug Act stated that the labels must list which three drugs?
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alcohol, cocaine, and opiates
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Which drug law had to do with the truth in labeling and was supposed to provide protection against false therapeutic claims?
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Sherley Amendment 1912
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What drug did The Harrison Act of 1914 deal with?
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opium
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Which law marked the first attempt to regulate and control addicting substances?
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Harrison Act of 1914
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What law gave the FDA power?
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Food Drug Cosmetic Act of 1938
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The Food Drug Cosmetic Act of 1938 left the prescription and efficacy up to the _________?
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manufacturers
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Which law allowed companies to sell OTC's w/o a prescription?
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Food Drug Cosmetic Act of 1938
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Which law dealt w/ safety and proper labeling?
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Food Drug Cosmetic Act of 1938
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Which law required a physician for a refill?
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Durham Humphrey Act-1951
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Which law was the first to have specific criteria for prescription?
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Durham Humphrey Act-1951
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Which law was the first to require the listing of side effects?
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Keauver Harris Amendment 1962
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Which law was the first to require testing for effectiveness?
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Keauver Harris Amendment 1962
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Which law stated that nutritional supplements don't need FDA approval?
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Dietary Health and Education Act of 1994
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What drug brought on the Keauver Harris Amendment?
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thalidomide
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What is the application for human testing?
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IND (investigational New Drug)
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How many volunteers are in the initial clinical stage and what types of ppl?
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20-100, prison inmates, med students, healthy volunteers
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What does stage one or the initial clinical stage test for?
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absorption/ excretion rates
range of safe doses admin schedule side effects |
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How many people does the clinical pharmacological stage test and what types of ppl?
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100-300
those w/ the condition |
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What stage of the drug approval process test for effectiveness and uses the double blind and placebo methods?
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Stage 2 (clinical pharmacological stage)
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What stage in the drug approval process deals with the fine tuning?
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stage 3( extended clinical eval.)
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The extended clinical eval. stage test how many people and what type of ppl?
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1000s
condition |
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What stage of the drug approval process does the company submit an application to the NDA (new drug app.)?
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stage 3 (extended clinical eval)
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How long does the FDA have to review an NDA
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6 mos.
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What year did generic drugs first come out?
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1984
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How long does the patent give exclusive rights to the drug co.?
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20 yrs
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What is the post distribution phase called in the drug approval process and what does it test for?
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phase 4, problems w/ the drug later on
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What is the FDA policy that allows the change from prescription to OTC?
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switching policy
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T or F: Schedule I drugs have no currently accepted medical use
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T
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A good way to implement supply reduction would be to make harsher _____.
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laws
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A good way to implement demand reduction would be to have a _______ _________.
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motivational speaker
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Inoculation emphasizes ________.
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responsibility
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Trying to control drug regulation on the borders is ______.
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interdiction
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These drug policies emphasize reducing demand.
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pragmatic
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4 common examples of anti-pyretics are......
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aspirin, ib pro, acetimonophen, naproxen
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3 common examples of anti- coagulents?
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aspirin, ib pro, acetomenophen
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What do NTM's bind to?
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receptors
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What NTM's have narcotic like effects?
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endorphins
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What selectively activates cannibinnoid receptors?
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anandamide
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What part of the brain effects cognitive, intellectual thinking as well as senses and decision making?
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cerebrum
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What part of the brain is developed at birth and effects motor control as well as depth perception?
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cerebellum
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If someone fails a field sobriety test, what part of the brain is not working properly?
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cerebellum
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If someone is hallucinating, what part of the brain is not working properly?
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cerebrum
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If someone's heart rate is running wild, what part of the brain is not working properly?
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brain stem
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What controls the brain's state of arousal?
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RAS
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This is part of the limbic system and is important in the rewards system
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nucleus accumbens
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What part of the limbic system is preferred to as the switch board?
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thalamus
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What part of the limbic system is referred to as the master gland?
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hypothalamus
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What part of the limbic system deals with long and short term memory?
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hippocampus
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What part of the limbic system deals with emotional response
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amygdala
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When you smell cookies and think about grandmas house, what part of the brain are you using?
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amygdala
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Somatic is voluntary or involuntary?
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voluntary
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Do you control your sympathetic nervous system?
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no
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Which system would be in tact when coming down off addy?
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parasympathetic
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Each neuron release how many NTMS?
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1
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What is the site of communication btwn neurons and target cells?
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synapse
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What houses neural transmitters?
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pre-synaptic terminals
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The excitatory impulse is also called the?
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action potential
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What counts excitatory/ inhibitory signals?
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cell body
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The receiving region is also called the_________
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dendrites
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Drugs have their effect in the_____
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synapse
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What type of drugs stop the transmission of a signal?
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pain killers
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Steroids slowing test production is an ex. of?
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mimicing the NTM
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Which is faster; topical mucous membrane or topical epidemis
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mucous membrane
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Capillaries in brain are protective agianst?
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hydrophyllic
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theurapeutic index is the ratio btwn the _______ dose and ____ dose
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effective toxic
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