Clinical Trials is an important to gather information about new drugs. What is the objective of the data gathered in each of the clinical trial phases? Identify one per phase.
Phase 0 (Exploratory):
Assess very early pharmacokinetics and target engagement using sub-therapeutic microdoses.
Phase I:
Determine safety, tolerability, and the appropriate dose range in healthy volunteers or a small group of patients.
Phase II:
Evaluate preliminary efficacy and further assess safety in patients with the target condition.
Phase III:
Confirm efficacy, monitor adverse reactions, and compare to standard treatments in larger patient populations to support regulatory approval.
Phase IV (Post-marketing):
Monitor long-term safety, identify rare adverse events, and evaluate effectiveness in real-world use; explore additional indications.
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