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Clinical Development Nomenclature Source: FDA, Clinical trials.gov 32₂ O FDA Requirements for Drug Approval Dose Finding: the FDA requires you to find the lowest effective dose. Pivotal Trials: The FDA requires 2 pivotal trials for drug approval, typically done in Phase III. Clinical Development Pathway Phase I: safety and tolerability. Phase II randomized: Tests 1-2 doses against placebo for efficacy (2-3 groups). Phase llb: Tests many (4-5) doses for efficacy (4-6 groups). Phase III dose-finding: Tests 2 doses against placebo for efficacy (3 groups). Phase III: Tests 1 dose against placebo for efficacy (2 groups). 27

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