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Phases of clinical trials

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Phases of clinical trials

Preclinical: Laboratory & animal models Goal: Explore if & how new treatment may work Phase I: Small number (eg, 20-100) of healthy subjects Goal: Evaluate toxicity, maximum tolerated dose, adverse effects, pharmacokinetics & pharmacodynamics of new treatment (safety) Phase II: Small number (eg, up to a few hundred) of affected subjects Goal ...

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