Phase
I: The experimental drug is tested in a small group
of healthy individuals (20-80) to evaluate its safety, determine a safe dosage
range, and identify side effects.
Phase II: The experimental drug is given to a group of patients with the disease being tested (100-300) to determine the drug effectiveness, dosage, and to further evaluate its safety by monitoring side effects.
Phase III: The experimental drug is given to a larger group of patients (1,000-3,000) to confirm its effectiveness, dosage, monitor side effects, and collect all relevant information to optimize therapeutic use.
Phase IV: Also called post-marketing study. The primary goal of phase IV trial is the long term assessment of the new drug safety and effectiveness.
Phase II: The experimental drug is given to a group of patients with the disease being tested (100-300) to determine the drug effectiveness, dosage, and to further evaluate its safety by monitoring side effects.
Phase III: The experimental drug is given to a larger group of patients (1,000-3,000) to confirm its effectiveness, dosage, monitor side effects, and collect all relevant information to optimize therapeutic use.
Phase IV: Also called post-marketing study. The primary goal of phase IV trial is the long term assessment of the new drug safety and effectiveness.
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