Econ Exam 2

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  1. Application for patent
    before clinical testing
  2. stages of drug development
    • preclinical research
    • preclinical testing
    • clinical testing
    • approval
  3. Patent approved
    between phase 1 and 2
  4. preclinical time frame
    3.5 years
  5. clinical testing time frame
    6 years
  6. approval time frame
    1 to 2.5 years
  7. total drug approval time
    10-13 years
  8. purpose for Phase 1 clinical trials
    • safe dose range
    • admin route
    • absorption and dist. mech
    • toxicity
  9. purpose for phase II clinical trials
    drug safety and efficacy in treating the target disease
  10. purpose for phase III clinical trials
    asses efficacy and dose range in treating specific disease in expanded group
  11. sample size for phase I CT
  12. sample size for phase II CT
  13. sample size for phase III ct
  14. time for phase I CT
    < 1 year
  15. time for phase II CT
    up to 2 years
  16. Investigational new drug application
    • between pre-clinical and clinical trials
    • demonstrates safety for testing on humans
  17. New Drug Application
    • between clinical and marketing
    • FDA reveiw
  18. Detailing
    information provided by sales force members
  19. Advantages of drug marketing
    • educates comsumers
    • increased compliance
    • increased communication
  20. disadvantages of marketing
    • increased price
    • induced demand
  21. drugs move from mfg to consumer via
    • pharmaceutical industry
    • wholesalers/distributors
    • pharmacies
  22. wholesalers
    • centralize purchasing and sales of drugs from the mfg
    • erriciency advantages
  23. customized limited distributions for orphan medications
    pharmaceutical companies
  24. distribution to ensure additional services take place durgin dispensing of medication
    • lab monitoring
    • needle disposal
    • counseling
    • special storage req.
  25. Primary arguments presented reguarding drug reimportation
    • safety issues
    • harm to recovery of R&D costs
    • prescription drug costs
  26. perceived susceptibility
    pt belief re. chance of getting a condition
  27. perceived severity
    pt. belief of how serious a condition is
  28. perceived benefits
    belief in efficacy
  29. perceived barriers
    tangible and psychological costs of advised action
  30. cues to action
    strategies to activate "rediness"
  31. self efficacy
    confidence in ability to take action
  32. driving factors behind increased drug use
    • new products
    • decreased copayments
    • post marketing research on clinical guidlines
    • generic drug use
Card Set
Econ Exam 2
drug development, consumer behavior, drug utilization trends
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