the science of chemicals that effect a living process
  2. toxicology is -
    adverse effects of chemicals
  3. drug therapy -
    " management" of disease with a medication
  4. a DRUG does what -
    alters an effect already existing in a quantitative manner of changes
  5. generic name-
    chemical name for a medication
  6. trade name -
    a manufacture's name for the generic product
  7. over the counter (otc) -
    non-prescriptive agent
  8. legend drug -
    prescriptive agent
  9. behind the counter (btc) -
    a non prescriptive drug that requires you to ask for it at the pharmacy, they keep track of how often someone gets that drug.
  10. controlled substance -
    prescriptive agent that has the potential for abuse, all are prescriptive drugs.
  11. bioavailable / bioequivalent -
    generic medications that have been determined to be equivalent
  12. additive -
    are two medications given together that produce an effect equal to the sum of the effects of each agent
  13. synergy -
    two medications given together that produce an effect much greater than the sum of the effects of each agent
  14. potentiation -
    is when two medications given together, but only one of the agents possess the required action, but that action is enhanced by the second agent.
  15. agonist -
    is an agent that stimulates a receptor
  16. antagonist -
    is an agent that blocks a receptor from being stimulated
  17. federal legislation
    what are the two pieces of legislation
    1938 food and drug cosmetic act - must prove safety (not effectiveness)

    1962 kefaver-harris amendment - must prove efficacy / grandfather clause
  18. investigational new drug (IND) procedure

    what is it required for -
    • - chemical or substance not previously used in humans
    • - new combination not used in combination before
    • - new use for a previously issued drug
    • - new dosage form
  19. investigational phases (4)

    name and describe -
    • phase 1 - determine safety and tolerated dose in a few "healthy" volunteers
    • phase 2 - determine safety, efficacy and pharmacokinetics in selected "diseased" individuals
    • phase 3 - determine safety and efficacy in widespread study
    • phase 4 - drug marketed with surveillance
  20. name 2 types of studies -
    double blind - neither the patient nor the doctor know if the patient is taking the drug or a plecebo

    single blind - doctor knows who is being tested or not, they can affect the outcome of the study.
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