Phase II

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Following initial safety (Phase I) testing, a drug is tested for efficacy, typically in blind, randomized trials, in which a control group receives a placebo. Phase II testing may last from several months to two years. Phase II trials involve 100-300 subjects with the disease or condition of interest. Includes PK, dose ranging, safety and efficacy.

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