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
I am just saying in best case scenario phase D III and F IV are...
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