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Phase II

Phase II trials test for efficacy as well as safety in a group of usually between 100 to 300 patients with the condition for which the medicine has been developed. Healthy volunteers are not included. Several Phase II trials are generally performed to test the drug in different patient populations and in different indications. Patients are closely monitored in Phase II trials but do not need to stay at the research centers.

The goals of a Phase II trial are to:

  • Assess short-term efficacy and safety of the drug
  • Determine the optimum dosage range for the drug (that is, find the dose at which the drug has the greatest efficacy with the least side effects)
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Phase II trials test for efficacy as well as experimental drug safety.