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Which phase involves controlled studies enrolling a limited number of patients?

  1. Phase I

  2. Phase II

  3. Phase III

  4. Phase IV

The correct answer is: Phase II

Phase II involves controlled studies enrolling a limited number of patients. This phase typically involves 100-300 patients and evaluates the effectiveness of the treatment on a particular disease or condition. Options A, C, and D are incorrect because Phase I involves testing a new treatment on a small group of healthy individuals, Phase III involves larger-scale studies comparing the new treatment to standard treatments, and Phase IV involves post-approval studies to monitor safety and effectiveness in a larger population.