Phase I Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase II Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
Phase III Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug.
Phase IV Studies of FDA-approved drugs to delineate additional information including thedrug's safety, benefits, or optimal use.
Phase Not Applicable Trials without phases (for example, studies of devices or behavioral interventions).
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