FDA Evaluation of Medication

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This phase of testing also helps determine the common short-term side effects and risks associated with the drug. Phase two studies often the most well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving several hundred people...
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There are variables in this part of research that are controlled and there are uncontrolled variables as well. This research is performed after preliminary evidence suggesting effectiveness of the drug has been obtained. The intention of this research is to gather additional information with regard to effectiveness and safety and attempts to be conclusive with answers about the drug as far as benefit/risk issues are concerned...
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