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Biotech / Medical : Biotech Questions and Answers
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To: Bert Klimer who wrote ()1/1/1999 9:24:00 PM
From: bluejeans  Read Replies (2) of 30
 
Phase 1 :the initial introduction into healthy human volunteers, the emphasis is on testing for safety (adverse effects), dosage tolerance, metabolism, distribution, excretion and clinical pharmacology.

Phase II : involves studies in a limited patient population to determine the efficacy of the pharmaceutical for specific targeted indications, to determine dosage tolerance and optimal dosage and to identify possible adverse side effects and safety risks.
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