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 upon the filing of a trial protocol with the appropriate regulatory body and designed to assess the efficacy for a specific indication of a compound proposed to be used as a 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 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 Arrow
Found in ARQULE INC contract
Phase II Clinical Trials. Shall mean Means clinical trials in a small sample of the intended patient population commencing upon the filing of a trial protocol with the appropriate regulatory body and designed to assess the efficacy for a specific indication of a compound proposed to be used as a 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 FDA or the equivalent Japanese agency for Phase II clinical trials. The completion of the A Phase II Clinical Trials will be Trial is deemed to have occurred commence upon acceptance of a trial protocol with the first formal internal issuance FDA and concludes with the filing of trial results as measured by trial objectives, or a final study report with the FDA, but in any event no not later than the commencement of the a Phase III Clinical Trials. Trial for that product. View More Arrow
Found in ARQULE INC contract
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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 Arrow
Found in ARQULE INC contract
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 Arrow
Found in ARQULE INC contract
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Phase II Clinical Trials. Shall mean those trials on sufficient numbers of patients that are designed to establish the safety and biological activity of a drug for its intended use, and to define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed, as further defined in Federal Regulation 21 C.F.R. 312.21.
Found in CYPRESS BIOSCIENCE INC contract
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