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Biotech / Medical : Biotech Questions and Answers
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To: bluejeans who wrote (2)1/1/1999 9:52:00 PM
From: Dr. Bob   of 30
 
Phase III: Extensive (hundreds or thousands of patients) trials, usually randomized, comparing the new drug against standard therapy or placebo, to document efficacy, and to determine side-effects which might be apparent in only a minority of patients. The final research step before FDA approval.

Phase IV: Additional FDA and company-sanctioned trials, often involving many thousands of patients, carried out after the drug is released. Differ from Phase III trials in that no control subjects are required, but considerable data is still accumulated, again looking for effects which might be present in only a very few patients and might only be discovered through careful record-keeping in large numbers of patients.

Bob
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