Phase 2/3 Study definition

Phase 2/3 Study means a clinical trial of a product that is (a) initiated to determine the safety and efficacy in the target patient population, as described in 21 C.F.R. 312.21(b) (as amended or any replacement thereof), or a similar clinical study prescribed by the Regulatory Authorities in a foreign country and (b) converted to a Phase 3 Study following an interim analysis of safety and efficacy data generated from the initial patents enrolled in such clinical trial.
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Phase 2/3 Study means a human clinical trial of a compound or product for an Indication, the principal purpose of which is a further determination of efficacy for such Indication and safety, in the target patient population, at the intended clinical dose or doses or range of doses, on a sufficient number of subjects and for a sufficient period of time to confirm the optimal manner of use of such compound or product (dose and dose regimen) for such Indication prior to Initiation of the pivotal Phase 3 Study for such Indication, and which itself provides sufficient evidence of safety and efficacy for such Indication that may be used directly to support the filing of a New Drug Application, without a Phase 3 Study, or to be included as a Phase 3 Study in filings with Regulatory Authorities.
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Phase 2/3 Study means a clinical trial of a product that is (i) initiated to determine the safety and efficacy in the target patient population, as described in 21 C.F.R. 312.21(b) (as amended or any replacement thereof), or a similar clinical study prescribed by the Regulatory Authorities in a foreign country and (ii) converted to a Phase 3 Study following an interim analysis of safety and efficacy data generated from the initial patents enrolled in such clinical trial.
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Examples of Phase 2/3 Study in a sentence

  • Subject to the remainder of this Section 4.1, all of Licensee’s development of Products will be conducted consistent with the Territory Development Plan, as such Territory Development Plan may be amended from time to time by Licensee pursuant to and in accordance with Section 4.1(b), except for those activities for which Licensee has agreed to conduct in support of any Global Phase 2/3 Study, as contemplated in Section 4.2(b), which shall be set forth in the Global Development Plan.

  • In the event that Licensee desires to participate in any such Global Phase 2/3 Study, Dermavant and Licensee shall discuss in good faith the feasibility thereof at the JSC and, if it is feasible, the terms and conditions for Licensee’s participation, which participation shall be subject in all cases to the consent of Dermavant in its reasonable discretion.


More Definitions of Phase 2/3 Study

Phase 2/3 Study means a Clinical Trial of a Licensed Product in diseased patients that satisfies the requirements of a Phase 2 Study and a Phase 3 Study.
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Phase 2/3 Study means any Phase 2 Study that includes a cohort of patients that would satisfy the requirement for a Phase 3 Study or would otherwise be sufficient for filing an NDA.
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