CPOC Study definition

CPOC Study mean a Phase II Clinical Trial in which the safety and efficacy of the product being tested are compared to placebo using prospectively defined study endpoints.
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Examples of CPOC Study in a sentence

  • If the Dose Escalation study of Combination rFVIIa/rFXIII is delayed, NN may consider and decide whether to proceed with a three (3) arm CPOC Study (i.e., without the Combination rFVIIa/rFXIII arm).

  • If the results of the CPOC Study based on the Primary Endpoint show that the Combination rFVIIa/rFXIII arm is superior to the rFXIII arm with [ * ], then Combination rFVIIa/rFXIII shall be deemed to be superior to rFXIII.

  • It is recognized that, in the event that the applicable Regulatory Agency requires a Primary Endpoint for either Phase III Clinical Trial that is not similar to the Primary Endpoint used for the corresponding CPOC Study and such requirement delays the start of the Phase III Clinical Trial, then the Time Milestones (as defined in Section 4.2) shall be delayed pursuant to Section 4.2(e)(iv).

  • If only one of rFXIII or Combination rFVIIa/rFXIII achieved CPOC in the CPOC Study described in Section 3.4 for an indication, it shall be the Phase III Development Candidate for the indication (i.e., [ * ] Indication or [ * ] Indication).

  • For the avoidance of doubt, the number of study subjects in a CPOC Study shall not be increased beyond the agreed [ * ] ([ * ]) study subjects per arm unless NN, in its sole discretion, decides otherwise.

  • If ▇▇ decides to proceed with a three (3) arm CPOC Study, the Parties will, in good faith, discuss and make appropriate adjustments under this Article 3.

  • Subject to Section 3.2(e), NN shall conduct a CPOC Study for each of the [ * ] Indication and the [ * ] Indication.

Related to CPOC Study

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]