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IND to proof of clinical concept

  • IND to proof of clinical concept is showing the effectiveness of a drug in treating a specific illness or condition within the intended patient population. This is accomplished by gathering evidence from various sources, including preclinical studies, early-phase clinical trials (phase 1 and phase 2), and confirmatory data from Phase 3 clinical trials. The proof of clinical concept validates the drug's potential for treating the targeted disease or condition.