Pharmacy Practice Chapter 3

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Across
  1. 3. the process by which a manufacturer submits research results from animal studies to the FDA to gain approval to gather data and test a new drug on humans
  2. 5. the process through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States
  3. 10. a drug that requires a prescription from a licensed provider for a valid medical purpose
  4. 15. a distinct segment of DNA that determines an organism’s specific individual characteristics, like blue eyes or brown hair
  5. 16. a class of drugs in which minute dilutions of natural substances stimulate the body’s immune system
  6. 17. a voluntary program by the FDA that allows any healthcare professional or consumer to report a serious adverse event associated with the use of any drug, biological device, or dietary supplement
  7. 18. the biochemically active component of a drug that exerts the desired therapeutic effect
  8. 20. a drug that kills bacteria, fungi, viruses, or even normal or cancer cells
  9. 23. a foreign substance or toxin introduced into the body that stimulates an immune response
  10. 25. a drug that delivers approximately the same amount of active ingredient into a healthy volunteer’s bloodstream in the same amount of time as the innovator or brand name drug
  11. 28. a compendium of standards and research created by the American Institute of Homeopathy
  12. 29. an unexpected negative consequence from taking a particular drug
  13. 33. a drug that kills bacteria
  14. 36. the part of the immune system that neutralizes antigens or foreign substances in the body
  15. 38. substances derived from the sciences of biology, chemistry, immunology, and genetic engineering to produce specific therapeutic effects
  16. 39. a warning that appears on the package insert and in other drug materials that highlights dangerous side effects
  17. 41. the process of withdrawing a drug from the market by the FDA or the drug manufacturer in response to serious adverse effects or other defects in the product
  18. 42. biosimilar drugs that are deemed as legal substitutions for biologically based brand drugs, many created through genetic engineering
  19. 44. generic biotechnology drugs
  20. 48. a cancer-fighting drug
  21. 49. a post-surveillance centralized database maintained by the FDA for all reported adverse events from drugs and vaccines
  22. 50. an inactive chemical—such as a filler, preservative, coloring, or flavoring—that is added to one or more active ingredients to improve drug formulations while causing little or no physiological effect; also called an inactive ingredient
  23. 52. a drug that helps a provider determine the correct diagnosis; may contain tracer radioactive isotopes or dyes used to help visualize problems
  24. 53. used to treat mental health diseases, such as depression
  25. 54. a unique number assigned to any brand name or generic drug products to identify the manufacturer, drug, and packaging size
  26. 56. refers to a substance that kills or inhibits the growth of microorganisms on the outside of the body to reduce the possibility of infection, sepsis, or putrefaction
  27. 57. a committee of the hospital that ensures that appropriate protection is provided to patients using investigational drugs; sometimes referred to as the Human Use Committee
Down
  1. 1. a substance used to stimulate the production of antibodies and provide immunity
  2. 2. a document that states, in easily understandable terms, the purpose and risks of the drug research that someone volunteers to take part in
  3. 4. the use of sterile products and devices to avoid contamination by disease-causing organisms;such as hand-washing and gowning procedures
  4. 6. the time it takes for a generic drug to reach the bloodstream after administration
  5. 7. a seal of approval from USP assuring the quality of a dietary supplement
  6. 8. the helix-shaped molecule that carries the genetic code
  7. 9. a drug that kills viruses, such as HIV
  8. 11. a drug created in the laboratory to imitate the effect of a naturally occurring drug
  9. 12. refers to a product that stimulates the growth of beneficial microorganisms
  10. 13. a postmarketing surveillance system operated by the FDA and CDC that collects information on adverse events that occur after vaccination
  11. 14. a category of nonprescription substances, which includes vitamins, minerals, and herbs, that is not regulated by the FDA
  12. 19. a field of study that examines the relationship between an individual’s genes and the body's response to drugs
  13. 21. a computer-generated digital prescription that is processed online
  14. 22. a drug that has been created from a series of chemical reactions to produce a specific pharmacological effect
  15. 24. a drug that may be sold without a prescription
  16. 26. secretions released by glands into the circulatory system that have specific regulatory effects on organs and other tissues; for instance, insulin is secreted from the pancreas to lower blood sugar
  17. 27. a hormone secreted by the pancreas, or an injected drug that helps cells burn glucose for energy
  18. 30. a drug substance that alters body functions in a desired way
  19. 31. one or multi-celled microscopic organisms, including bacteria, viruses, fungi, and protozoa
  20. 32. the process by which applicants must scientifically demonstrate to the FDA that their generic product is bioequivalent to or performs similarly to the innovator (brand name) drug
  21. 34. a drug that targets a specific need of the body (relieve pain, combat illness, etc...)
  22. 35. a federal agency created to protect the consumer from deceptive advertising, as with dietary supplements
  23. 37. any substance taken into or applied to the body for the specific purpose of altering the body’s biochemical functions and physiological processes; also called a medication
  24. 40. the process of using DNA biotechnology to create a variety of drugs or biological products
  25. 43. the field of study that combines the sciences of biology, chemistry, and immunology to produce unique synthetic drugs with specific therapeutic effects
  26. 45. a drug that contains both natural and synthetic components
  27. 46. the scientific concept that microorganisms cause disease
  28. 47. a drug used to prevent disease, such as aspirin to prevent heart attacks
  29. 51. immunity
  30. 55. a program designed by the FDA for prescribers, pharmacies, and patients to closely monitor selected high-risk drugs