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Preclinical Stage, Several Years

Preclinical Stage
Before a potential treatment can be tested in humans, it must first be rigorously studied in the laboratory and in animal models. This preclinical stage can last several years and is essential in identifying which treatments show promise for humans.

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Safety, 12 - 24 Months

Phase I - Safety
Researchers test a new drug or treatment in a small group of people for the frst time to evaluate its safety, determine a safe dosage range, and identify side effects.

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Safety and Efficacy, 24 Months

Phase II - Safety and Efficacy
The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

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Efficacy and Dosing, 24 Months

Phase III - Efficacy and Dosing
The drug or treatment is given to a large group of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely.

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FDA Approval, 12 Months

FDA Approval
A potential treatment that has shown to be both safe and effective in Phase III may be submitted for FDA approval. If approved, the treatment may be put on the market to be prescribed for use by the general public.

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Complete Timeline

Complete Timeline

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