Phase II Clinical Trials

Example Definitions of "Phase II Clinical Trials"
Phase II Clinical Trials. Shall mean clinical trials in a small sample of the intended patient population commencing on the filing of a trial protocol with the appropriate regulatory authority to assess the efficacy for a specific indication of a compound proposed to be used as a prophylactic, therapeutic or diagnostic pharmaceutical product, to determine dose tolerance and the optimal dose range as well as to gather additional information relating to safety and potential adverse effects, and meeting the requirements... established by the U. S. Food and Drug Administration for Phase II clinical trials. View More
Phase II Clinical Trials. Shall mean clinical Clinical trials in a small sample of the intended patient population commencing on upon the filing of a trial protocol with the appropriate regulatory authority body and designed to assess the efficacy for a specific indication of a compound proposed to be used as a prophylactic, therapeutic or diagnostic pharmaceutical product, to determine dose tolerance and the optimal dose range as well as to gather additional information relating to safety and potential adverse effects,... and meeting the requirements established by the U. S. Food and Drug Administration FDA or the equivalent Japanese agency for Phase II clinical trials. The completion of the Phase II Clinical Trials will be deemed to have occurred upon the first formal internal issuance of trial results as measured by trial objectives, or in any event no later than the commencement of the Phase III Clinical Trials. View More
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