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Test the agent's (ie. vaccine or drug) safety and toxicity in animals before beginning clinical trials on humans
Administer microdoses of the test agent to see if it behaves in people as expected.
Assess the dosage and safety of the agent in a group of 10 to 100 participants.
Assess the efficacy and monitor the side effects of the agent in 200 to 300 people.
Assess efficacy, effectiveness and safety of the agent in a larger group of 1000 to 3000 people. Once the drug passes Phase III, it may become approved by the country to advance to Phase IV.
Monitor longer term effects of the agent and compare to existing or similar agents in the market. Agents tested in Phase IV have already been approved by the country's regulating body and in the market.