Pharmacology Chapter 1

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  1. Who monitors and regulates a drug?
  2. Preclinical trials
    chemicals identified that might have therapeutic activity tested in animals

    Fail: inactive, too toxic, terotogenic, narrow safety margins
  3. Phase 1

    human volunteers that are young, healthy, male

    Fail: inactive, too toxic, teratogenic, too many adverse effects
  4. Phase 2

    human volunteers who have target disease or condition

    Fail: less effective, too toxic, too many adverse effects, low benefit to risk ratio, no more effective than current (cost prohibitive for further marketing)
  5. Phase 3
    use clinically with perscribers, Info collected by drug company and shared with FDA
  6. Phase 4
    continual monitoring by perscribers with reporting to FDA
  7. Pure Food and Drug Act
    Prevented the marketing of adulterated drugs; required labeling to elimanate false or misleading claims

  8. Federal Food, Drug and Cosmetic Act

    Mandated tests for drug toxicity and provided menas for recall of drugs; established procedures for introducing new drugs; gave Food and Drug Administration (FDA) the power of enforcement
  9. Durham-Humphrey Amendment

    Tightened control of certain drugs; specified drugs to be labeled "may not be distributed without a prescription"
  10. Kefauver-Harris Act

    Tightened control over the quality of drugs; gave FDA regulatory power over the procedure of drug investigations; stated that efficacy as well as safety of durgs had to be established
  11. Controlled Substances Act

    Defined drug abuse and classified drugs as to their potential for abuse; provided strict controls over the distribution, storage, and use of these drugs. Gave enforcement to the DEA
  12. Orphan Drug Act

    Provided incentives for the development of orphan drugs for treatment of rare diseases
  13. teretogenic
    having an adverse effect on the fetus
  14. Pregnancy Category A
    adequate studies in pregnant women with no demonstrated risk to fetus
  15. Pregnancy category B
    animal studies have not demonstrated a risk to the fetus, but no studies in pregnancy OR animal studies adverse, but studies in pregnant women okay
  16. Pregnancy Category C
    animal studies have shown an adverse effect on the fetus, but no adequate human studies
  17. Pregnancy Category D
    Evidence of human fetal risk, but benefits to pregnant women may be acceptable
  18. Pregnancy Category X
    all risk no benefit
  19. Scheduale I drug
    High abuse potential and no acceptable medical use 

    Example: Heroine, LSD
  20. Schedule II drug
    High abuse potential with sever dependence liability 

    Examples: Morphine, Demerol, Oxycodone
  21. Schedule III drug
    • less abuse potential than schedule II with moderate dependence
    • Examples:  Codeine with acetaminophen (Tylenol #3)
  22. Schedule IV drug
    • Less abuse potential than Schedule II with limited dependence liability
    • Examples: Xanax (alprazolam)
  23. Schedule V drug
    • Limited abuse potential and dependence. 
    • Examples: cough meds
  24. Orphan drugs
    medicines that a company hasnt adopted because the demand is so small that it will not be much of a profit

    • Example:  
    • Cinryze 1,000 units every 3-4 days.
    •        1 vile has 500 units
    •         cost per vile $2411.58 with coupon 
  25. References
    • PDR
    • Package Inserts
    • Medical Letter
    • Journal Reviews
    • Drug Facts and Comparisons
    • Pharmacist
    • Internet Sources 
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Pharmacology Chapter 1
pharmacology exam 1
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