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4 Cards in this Set
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Phase I
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Initial introduction of drug for human use (Physician must order).
A patient participating in an investigational drug study must sign an informed consent. Participation is voluntary and the patient may withdraw at any time. Clinical studies are performed on 5 to 20 volunteer patients. |
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Phase II
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Establishes effectiveness and relative safety
Limited trials Patients are closely monitored |
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Phase III
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Specifies effective / indications
More precise definitions of adverse effects |
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Phase IV
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Post-marketing trials
Long term No control groups involved All remaining investigational drugs should be returned to the person(s) responsible for the drug. |
