how do I perform a clinical trial for Xiliiarx in the treatment of Type 2 diabetes as a pharmacist assuming I want to do the same as the previous clinical trial?

how do I perform a clinical trial for Xiliiarx in the treatment of Type 2 diabetes as a pharmacist assuming I want to do the same as the previous clinical trial? What are the step by step specific activities I need to carry out for a successful clinical trial?

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Expert Solution

Begin with the phase I studies. This will validate the safety of Xiliiarx. This includes a small number of healthy volunteers. This phase will provide information about the effects of this drug.

Continue with phase II studies. In this step, you will measure the efficacy of Xiliiarx on diabetes type 2 persons. It includes a randomized trial with two groups, one receives the drug, and the other a placebo.

Continue with phase III studies. This involves the test of the drug but in several hundred or thousand patients. Finishing this trial, the FDA can approve its use in the market.

Finally, phase IV studies involve the feedback and comparison of the efficacy of the drug.

Reference: FDA protocol

gladiator answered 1 year ago

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