Phases of human medication testing
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Phase I: Clinical Pharmacology
Meds are given to healthy volunteers, usually males between 18 - 45. Used to determine dose levels of toxicity.
Phase II: Clinical Investigation
Given to limited number of patients with targeted disease. Used to establish medication effectiveness, and optimum dosage range
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.
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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