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Biotech / Medical : Biotech Questions and Answers -- Ignore unavailable to you. Want to Upgrade?

To: bluejeans who wrote (2)1/1/1999 9:52:00 PM
From: Dr. Bob  Respond to 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



To: bluejeans who wrote (2)1/1/1999 11:46:00 PM
From: Bert Klimer  Respond to of 30
 
Thanks a lot! Do you know how long phase II normally lasts and if there is another phase before FDA approval is normally granted?

Bert


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