Phases of human medication testing

  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.
Card Set
Phases of human medication testing
Phases of human medication testing