Correct Answers Verified, Exams of Advanced Education
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1. Pharma companies must submit extensive data to the FDA demonstrating the safetyand effectiv
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enessofnewdrugsbeforereceiving approval forsale.-
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l (ANSWER) True l
2. Average review time for a new drug (ANSWER)18 months l l l l l l l l l
3. SalesTeam (ANSWER)Pg 7 l l l l
4. The "engineofinnovation," focusedondiscoveringorinventingpromising new product. (ANSWE
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R) Research & Development
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5. Thisincludessupplychain,manufacturing,trade,anddistributionfunctions of the business. (ANSW
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ER) Manufacturing & Operations
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6. In 2012,FDA regulators approved 39 new drugs for use in the U.S. (ANSWER)True
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7. 3,070 new meds are in development for cancer. (ANSWER)True
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8. DefineOff- l
label (ANSWER) Usageofamedicationforpurposesotherthanthespecificones appearing on the la
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bel
9. Toxicity (ANSWER)The extent, quality,or degree to which a substance ispoisonous or harmf
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ul to the body
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10. Institutional review Board (IRB) (ANSWER) A committee of physicians, staticians, com- l l l l l l l l l l
l munity advocated,andotherswhichensure thataclinical trialisethicaland thatthe rights of the study
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participants are protected.All clinical trials must be approved by an IRB before they begin.
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,11. Placebo (ANSWER)Inactive pill, liquid, or powder that has no treatment value aka sugar pill
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12. Edema (ANSWER)Swelling l l
13. Asymptomatic (ANSWER)Without signs or symptoms l l l l l
14. ClinicalPharmacology (ANSWER)The studyoftheeffectsandmovement ofdrugsinthe human
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body
15. Anatomy (ANSWER) The study of basic structures of the body l l l l l l l l l
16. Physiology (ANSWER)The study of how those body structures function l l l l l l l l l
17. Basic clinical pharmacology involves 3 main concepts (ANSWER)Pharmacodynam-
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l ics, Pharmacokinetics, drug distribution and elimination.
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18. Pharmacodynamics (ANSWER) Study of the biochemical and physiological effects of drugsan l l l l l l l l l l l
d theirmechanisms ofactioni.e.the studyofwhatadrugdoestothebody. It describes the therapeutic
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effects of drugs (pain relief, blood pressure reduction, their side effects and their sites of action.
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19. Pharmacokinetics (ANSWER)Studyofhowadrugisprocessedbythebody,withempha- l l l l l l l l l l l l l
l sis on the time required for absorption, duration of action, distribution, and method of excretion.Th
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e study of how the body affects drugs.
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20. Drugdistribution&elimination (ANSWER) Drugdelivery systems,routeofadministration
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, modes of excretion.
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, 21. Plasma (ANSWER)The liquid portion of the blood that carries proteins and other sub-
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l stances
22. Organs (ANSWER)Specializedcellsandtissuesgroupedtogethertoperformspecificbody func
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tion for a common purpose. (Kidney, heart, intestines, and skin)
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23. Nucleus (ANSWER)Brain of the cell that regulates all activities. l l l l l l l l l
24. Proteins (ANSWER) A nutrient made up of of chains of amino acids l l l l l l l l l l l
25. Fats (ANSWER)A nutrient stored in special body tissues as a great source of reserve energ
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y
26. Carbohydrates (ANSWER)A nutrient that is the body's immediate source of energy.It's brok l l l l l l l l l l l l l
en down to glucose and used for immediate metabolic reactions.
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27. Vitamins (ANSWER)Anutrientsubstancenecessaryforgrowth,development,andnormal regul
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ation of metabolic processes.Must be taken from outside the body.
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28. Minerals (ANSWER) Anutrientnecessaryforbodilypurposessuchasthe balanceofbody fluid l l l l l l l l l l l l l l
29. Water is NOT a nutrient (ANSWER)True l l l l l l
30. Body'sMajorSystems (ANSWER)Cardiovascular,Respiratory,nervous,musculoskele-
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l tal, reproductive, immune
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31. Absorption (ANSWER)Howthedrugpassesfromitssideofadministrationinto theblood- l l l l l l l l l l l l l
l stream
32. Distribution (ANSWER)How thedrugisdispersedamong theorgansafterabsorptioninto the bl l l l l l l l l l l l l l l
ood
33. Metabolism (ANSWER) Howtheactivepartofadrugismetabolizedintoamorewater-sol- l l l l l l l l l l l l l l
l uble compound that can be readily excreted by the kidneys
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34. Excretion (ANSWER)How the drug is eliminated from the body.Usually drugs are elimi- l l l l l l l l l l l l l
l 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 (ANSWER)True
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36. Routes of drug administration (ANSWER)Pg 26-29 l l l l l l