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won't be long before next major announcement, page-19

  1. 2,858 Posts.
    I am just saying in best case scenario phase D III and F IV are not done? Am I correct?
    D. Phase III

    1. Multicenter, controlled and open trials
    2. Involve 600-1000 patients
    3. Average of 3 years in duration
    4. “Pivotal studies” are usually Phase III trials that get the drug approved by the FDA
    5. Purpose: Establishes safety and efficacy

    F. Phase IV (Post-marketing surveillance)

    1. Conducted based on the approved indication
    2. May evaluate the following:

    a. New doses
    b. Effects of extended therapy
    c. Safety in patient populations not represented in previous clinical trials
 
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