1. Pharma companies must submit extensive data to the FDA demonstrating the safety and effe
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ctiveness of new drugs before receiving approval for sale.-
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P ANS TruePP
2. Average review time for a new drug ANS 18 months
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3. Sales Team ANS Pg 7 P P PP P
4. The "engine of innovation," focused on discovering or inventing promising new product. ANS R
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esearch & Development P P
5. This includes supply chain, manufacturing, trade, and distribution functions of the business. ANS
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Manufacturing & Operations P P
6. In 2012, FDA regulators approved 39 new drugs for use in the U.S. ANS True
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7. 3,070 new meds are in development for cancer. ANS True
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8. Define Off- P
label ANS Usage of a medication for purposes other than the specific ones appearing on the labe
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l
9. Toxicity ANS The extent, quality, or degree to which a substance is poisonous or harmful t
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o the body
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10. Institutional review Board (IRB) ANS A committee of physicians, staticians, com-
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P munity advocated, and others which ensure that a clinical trial is ethical and that the rights of the s
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tudy participants are protected. All clinical trials must be approved by an IRB before they begin
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.
,11. Placebo ANS Inactive pill, liquid, or powder that has no treatment value aka sugar pill
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12. Edema ANS Swelling P PP
13. Asymptomatic ANS Without signs or symptoms P PP P P P
14. Clinical Pharmacology ANS The study of the effects and movement of drugs in the human bo
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dy
15. Anatomy ANS The study of basic structures of the body
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16. Physiology ANS The study of how those body structures function
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17. Basic clinical pharmacology involves 3 main concepts ANS Pharmacodynam-
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P ics, Pharmacokinetics, drug distribution and elimination.
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18. Pharmacodynamics ANS Study of the biochemical and physiological effects of drugs and th P PP P P P P P P P P P P
eir mechanisms of action i.e. the study of what a drug does to the body. It describes the therapeuti
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c effects of drugs (pain relief, blood pressure reduction, their side effects and their sites of actio
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n.
19. Pharmacokinetics ANS Study of how a drug is processed by the body, with empha- P PP P P P P P P P P P P P
P sis on the time required for absorption, duration of action, distribution, and method of excretion
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. The study of how the body affects drugs.
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20. Drug distribution & elimination ANS Drug delivery systems, route of administration
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, modes of excretion.
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, 21. Plasma ANS The liquid portion of the blood that carries proteins and other sub- stances
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22. Organs ANS Specialized cells and tissues grouped together to perform specific body functio
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n for a common purpose. (Kidney, heart, intestines, and skin)
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23. Nucleus ANS Brain of the cell that regulates all activities.
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24. Proteins ANS A nutrient made up of of chains of amino acidsP PP P P P P P P P P P
25. Fats ANS A nutrient stored in special body tissues as a great source of reserve energy
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26. Carbohydrates ANS A nutrient that is the body's immediate source of energy. It's broken P PP P P P P P P P P P P P P
down to glucose and used for immediate metabolic reactions.
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27. Vitamins ANS A nutrient substance necessary for growth, development, and normal regulati
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on of metabolic processes. Must be taken from outside the body.
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28. Minerals ANS A nutrient necessary for bodily purposes such as the balance of body fluid
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29. Water is NOT a nutrient ANS True P P P P P PP
30. Body's Major Systems ANS Cardiovascular, Respiratory, nervous, musculoskele-
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P tal, reproductive, immune
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31. Absorption ANS How the drug passes from its side of administration into the blood- stream
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32. Distribution ANS How the drug is dispersed among the organs after absorption into the bloo
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d
33. Metabolism ANS How the active part of a drug is metabolized into a more water-sol-
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P uble compound that can be readily excreted by the kidneys
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34. Excretion ANS How the drug is eliminated from the body. Usually drugs are elimi-
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P nated via urine. They can also be excreted through the lungs, skin, or breast milk.
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35. It takes about 10 years for a drug to hit the market ANS True
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36. Routes of drug administration ANS Pg 26-29 P P P P PP P
37. Seven rights of drug administration ANS pg 30
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38. Bioavailability ANS how quickly and how much of a drug reaches its intended target site of a P PP P P P P P P P P P P P P P P
ction