Apr 6, 2014
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Studies which test drug safety and efficacy prior to registration. 1. Phase I: a study in human volunteers to establish safety of a pharmaceutical agent. 2. Phase II: the first investigation of a new drug in patients to determine the preliminary evidence of efficacy and to confirm safety. 3. Phase III: trials designed to determine long term safety, efficacy and cost-effectiveness of a new drug in large numbers of patients.

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