PHRD5925 Pharmaceutics - Pharmacy History

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  1. definition of a drug
    • agent intended for use in the...
    • 1) diagnosis
    • 2) mitigation
    • 3) treatment
    • 4) cure
    • 5) prevention 
    • of disease in humans or other animals
  2. the only difference between a drug and a poison is...
    the dose
  3. approximate date drugs date back to
    3000 BC
  4. most famous ancient writing on drugs
    Ebers papyrus
  5. common drug delivery vehicles  in early pharmacy history (4)
    • 1) beer
    • 2) wine
    • 3) milk
    • 4) honey
  6. meaning of "pharmakon" by Hippocrates
    purifying remedy for good only 
  7. first to write about preparing drugs by mixing and compounding (130-200 AD), and proposed that heart pumps blood
  8. Persian that wrote the Canon of Medicine, and introduced the concepts of quarantine & clinical trials
  9. text that stated that disease could be spread through water, soil, or air
    Canon of Medicine
  10. when pharmacy was officially separated from medicine by German emperor
  11. "Father of Pharmacy"; transformed profession of pharmacy from one based on botany to one based on chemistry
  12. when Pharmacopeia of London published
  13. when morphine was isolated from opium
  14. when United States Pharmacopeia (USP) published
  15. when Philadelphia College of Pharmacy was established as the nation's first pharmacy school
  16. when the first organic molecule was synthesized (urea)
  17. when cocaine extracted from coca
  18. when Germ Theory was developed by Pasteur
  19. when rabies vaccine was developed
  20. when the National Formulary (NF) was created
  21. when diacetylemorphine (heroin) and aspirin were introduced
    late 1890s
  22. first Pure Food & Drug Act signed (designated that drugs had to be properly labeled)
  23. when first drug found to be curative (arsphenamine for syphilis)
  24. required strict accounting of opium and coca (by taxation)
    Harrison Act of 1914
  25. when Congress passes Federal Food, Drug, and Cosmetic Act and created the FDA
  26. important points of FDCA of 1938 (2)
    • 1) NDA has to be filed before distribution/use of new drug
    • 2) product must be safe (but not necessarily efficacious)
  27. limited new drugs to prescription-only dispensing
    Durham-Humphrey Amendment of 1952
  28. required that drugs were both safe AND effective for FDA approval, and IND before human testing
    Kefauver-Harris Drug Amendments of 1962
  29. measles & mumps vaccines
  30. made marijuana illegal
    Comprehensive Drug Abuse Act of 1970
  31. sources of new drugs (6)
    • 1) plants
    • 2) animals
    • 3) cell cultures
    • 4) recombinant DNA tech
    • 5) gene therapy
  32. on average, how long it takes for an experimental drug to travel from the lab to US patients
    10-15 years
  33. purpose of Phase I testing
    determine safety and dosage (in healthy volunteers)
  34. purpose of Phase II testing
    evaluate effectiveness, look for side effects (in patient volunteers)
  35. purpose of Phase III testing
    confirm effectiveness, monitor adverse reactions from long term use
  36. minimum concentration that can be expected to produce the drug's desired effect
    minimum effective concentration (MEC)
  37. serum level above which drug-related toxic effects are expected
    minimum toxic concentration (MTC)
  38. amount of drug that will produce the desired effect in 50% of the individuals tested
    median effective dose (ED50)
  39. amount of drug that will produce a toxic effect in 50% of the individuals tested
    median toxic dose (TD50)
  40. TD50/ED50 (ratio between median toxic dose and median effective dose)
    therapeutic index
  41. facilitates the development of drugs for treating diseases that affect <200,000 people in the US
    Orphan Drug Act of 1983
  42. monitor safety and efficacy of a drug after marketing
    Phase IV studies
  43. approx 1 in ___ compounds makes it to the market
  44. allows applications for generic copies of approved drugs to be filed through an abbreviated new drug application (ANDA) after 17 years
    Drug Price Competition and Patent Term Restoration Act of 1984
  45. the only clinical testing required for an ANDA
    assess drug bioavailability
  46. what can vary in generic form
    inactive ingredients
  47. Molarity (M)
    (moles of solute) / (1L solution)
  48. molality (m)
    (moles solute) / (1000g solvent)
  49. mole fraction (X)
    (mol solute) / (total mol)
  50. percent by weight (%w/w)
    (g solute) / (100g solution)
  51. percent by volume (%v/v)
    (mL solute) / (100mL solution)
  52. percent by weight-in-volume (%w/v)
    (g solute) / (100mL solution)
  53. density
    • (g solution) / (1mL solution)
    • OR
    • g/cm3
  54. average adult BSA
    • 1.73m2
  55. equation for adjusted patient dose
    [(BSA of patient)/1.73)] * (adult dose)
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PHRD5925 Pharmaceutics - Pharmacy History
2014-02-03 06:51:55
Pharmacy History

Pharmacy History
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