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Which phase is primarily focused on assessing a drug's toxicity, pharmacokinetics (PK), and pharmacodynamics (PD)?

  1. Phase I

  2. Phase II

  3. Phase III

  4. Phase IV

The correct answer is: Phase I

Phase I is primarily focused on assessing a drug's toxicity, pharmacokinetics (PK), and pharmacodynamics (PD). It is the first phase of clinical trials and involves testing the drug on a small group of healthy volunteers to determine its safety, how it is absorbed and eliminated by the body, and its effects on the body. Phase II and Phase III focus on testing the drug's effectiveness and further safety evaluations in larger groups of patients. Phase IV, also known as post-marketing surveillance, occurs after the drug has been approved and is focused on continued monitoring and surveillance of the drug's safety and effectiveness in a larger population. Therefore, options B, C, and D are incorrect as they primarily focus on effectiveness and safety evaluations in different stages of clinical trials.