Phases of human medication testing

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The flashcards below were created by user kelleeeh on FreezingBlue Flashcards.


  1. Phase I: Clinical Pharmacology
    Meds are given to healthy volunteers, usually males between 18 - 45. Used to determine dose levels of toxicity.
  2. Phase II: Clinical Investigation
    Given to limited number of patients with targeted disease. Used to establish medication effectiveness, and optimum dosage range
  3. Phase III: Clinical Trials
    If no harmful side effects are found in P-II, meds are given to thousands of patients in large research facilities. Blind and double blind studies are conducted. Results must be thoroughly documented and researched.
  4. Phase IV: Post-marketing Study
    Occurs after release of med. Includes results from patients previously excluded from trials, i.e., pregnant and elderly. Results gathered, analyzed, reported to FDA.

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Author:
kelleeeh
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26950
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Phases of human medication testing
Updated:
2010-07-15 23:29:59
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Phases human medication testing
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Phases of human medication testing
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