Phases of human medication testing

Meds are given to healthy volunteers, usually males between 18 - 45. Used to determine dose levels of toxicity.

Given to limited number of patients with targeted disease. Used to establish medication effectiveness, and optimum dosage range

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.

Occurs after release of med. Includes results from patients previously excluded from trials, i.e., pregnant and elderly. Results gathered, analyzed, reported to FDA.