Pharmacy Practice Chapter 3
Across
- 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
- 5. the process through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States
- 10. a drug that requires a prescription from a licensed provider for a valid medical purpose
- 15. a distinct segment of DNA that determines an organism’s specific individual characteristics, like blue eyes or brown hair
- 16. a class of drugs in which minute dilutions of natural substances stimulate the body’s immune system
- 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
- 18. the biochemically active component of a drug that exerts the desired therapeutic effect
- 20. a drug that kills bacteria, fungi, viruses, or even normal or cancer cells
- 23. a foreign substance or toxin introduced into the body that stimulates an immune response
- 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
- 28. a compendium of standards and research created by the American Institute of Homeopathy
- 29. an unexpected negative consequence from taking a particular drug
- 33. a drug that kills bacteria
- 36. the part of the immune system that neutralizes antigens or foreign substances in the body
- 38. substances derived from the sciences of biology, chemistry, immunology, and genetic engineering to produce specific therapeutic effects
- 39. a warning that appears on the package insert and in other drug materials that highlights dangerous side effects
- 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
- 42. biosimilar drugs that are deemed as legal substitutions for biologically based brand drugs, many created through genetic engineering
- 44. generic biotechnology drugs
- 48. a cancer-fighting drug
- 49. a post-surveillance centralized database maintained by the FDA for all reported adverse events from drugs and vaccines
- 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
- 52. a drug that helps a provider determine the correct diagnosis; may contain tracer radioactive isotopes or dyes used to help visualize problems
- 53. used to treat mental health diseases, such as depression
- 54. a unique number assigned to any brand name or generic drug products to identify the manufacturer, drug, and packaging size
- 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
- 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. a substance used to stimulate the production of antibodies and provide immunity
- 2. a document that states, in easily understandable terms, the purpose and risks of the drug research that someone volunteers to take part in
- 4. the use of sterile products and devices to avoid contamination by disease-causing organisms;such as hand-washing and gowning procedures
- 6. the time it takes for a generic drug to reach the bloodstream after administration
- 7. a seal of approval from USP assuring the quality of a dietary supplement
- 8. the helix-shaped molecule that carries the genetic code
- 9. a drug that kills viruses, such as HIV
- 11. a drug created in the laboratory to imitate the effect of a naturally occurring drug
- 12. refers to a product that stimulates the growth of beneficial microorganisms
- 13. a postmarketing surveillance system operated by the FDA and CDC that collects information on adverse events that occur after vaccination
- 14. a category of nonprescription substances, which includes vitamins, minerals, and herbs, that is not regulated by the FDA
- 19. a field of study that examines the relationship between an individual’s genes and the body's response to drugs
- 21. a computer-generated digital prescription that is processed online
- 22. a drug that has been created from a series of chemical reactions to produce a specific pharmacological effect
- 24. a drug that may be sold without a prescription
- 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
- 27. a hormone secreted by the pancreas, or an injected drug that helps cells burn glucose for energy
- 30. a drug substance that alters body functions in a desired way
- 31. one or multi-celled microscopic organisms, including bacteria, viruses, fungi, and protozoa
- 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
- 34. a drug that targets a specific need of the body (relieve pain, combat illness, etc...)
- 35. a federal agency created to protect the consumer from deceptive advertising, as with dietary supplements
- 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
- 40. the process of using DNA biotechnology to create a variety of drugs or biological products
- 43. the field of study that combines the sciences of biology, chemistry, and immunology to produce unique synthetic drugs with specific therapeutic effects
- 45. a drug that contains both natural and synthetic components
- 46. the scientific concept that microorganisms cause disease
- 47. a drug used to prevent disease, such as aspirin to prevent heart attacks
- 51. immunity
- 55. a program designed by the FDA for prescribers, pharmacies, and patients to closely monitor selected high-risk drugs