clinical+trial

__Clinical Trials__ Clinical trials contain a specific process which includes three phases: Phase I determines what the proper dosage of the product is based on a trial of less than 100 subjects. Phase II determines efficacy, effectiveness and safety of the product based on a trial of 100- 200 subjects. Phase III determines the long-term efficacy, effectiveness and safety of the product based on a trial of thousands of subjects.

Throughout these three phases, the trials must be in accordance with FDA's good clinical practice rules which includes institutional review boards, review of protocols, and informed consent of subjects. Once the drug is approved and proven to be effective it must comply with FDA regulation of labeling which must be "consistent with approved uses" and include side effects.



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