Phase IIb Trial definition

Phase IIb Trial means a Phase II Trial that is intended to establish the dosing regimen for use in a Phase III Trial of a Pfizer Product or an Incyte Product, as the case may be, for a specific indication.
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Phase IIb Trial means any controlled dose ranging Phase II Trial of a pharmaceutical product to further evaluate the efficacy and safety of the product in its target patient population and to define the product’s optimal dosing regimen, as may be conducted anywhere in the world, and in any case that is designed to obtain data to select particular doses to be used in a Phase III Trial.
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Phase IIb Trial means a well-controlled, closely monitored, human clinical trial conducted to evaluate the dose-dependent effectiveness of a Product for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the Product as more fully defined in 21 CFR Section 312.12(b), as amended from time to time.
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Examples of Phase IIb Trial in a sentence

  • Alba Therapeutics Announces Positive Results of Phase IIb Trial in Celiac Disease [Internet].

  • If not, please tell us where the costs for AE37 in combination with GM-CSF were recorded in your financial statements and revise your MD&A as necessary to discuss the costs incurred.The Phase IIb Trial, which is discussed on page 4, is for AE37 in combination GM-CSF and is not the same trial as the Phase II trial for AE7 in combination with Keytruda.

  • Approximately 90 women who have seroconverted while in the active or placebo arms of the CAPRISA 004 (Phase IIb Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% tenofovir Gel for the Prevention of HIV Infection in Women in South Africa) study and the CAPRISA 008 (Phase IIIb Open-Label Randomized Controlled Trial to Assess the Effectiveness and Safety of Tenofovir Gel Provision through Family Planning Services in KwaZulu-Natal, South Africa) study will be enrolled.

  • AVI Media Contact: David Schull 858.717.2310 or 212.845.4271 David.Schull@russopartnersllc.com AVI BioPharma Announces Eteplirsen Meets Primary Endpoint, Demonstrating a Significant Increase in Dystrophin at 24 Weeks Compared to Placebo in Phase IIb Trial for the Treatment of Duchenne Muscular Dystrophy BOTHELL, WA – April 2, 2012 – AVI BioPharma, Inc.

  • There were no costs incurred by the Company related to the Phase IIb Trial in fiscal years 2018, 2019 or in the nine months ended April 30, 2020.•You state on page 5 that "based on the results from the Phase II trial described above, NGIO entered into a Clinical Trial Collaboration and Supply Agreement" on June 28, 2017 with Merck.


More Definitions of Phase IIb Trial

Phase IIb Trial means a controlled dose ranging study to evaluate further the efficacy and safety of a Product in the targeted population and to define the optimal dose regimen;
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Phase IIb Trial means a double-blind, placebo-controlled, dose finding study in a specific chronic pain indication designed so as to achieve the first Milestone Event set forth in Section 6.3.
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Phase IIb Trial means a Phase II Trial, designed to support and immediately precede the initiation of a Phase III Trial program without any further Phase II Trials, to evaluate the dose-dependent effectiveness of a pharmaceutical product for a particular indication or indications in patients with the disease or condition under study and to determine the common side effects and risks associated with the pharmaceutical product.
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Phase IIb Trial means, with respect to the United States, any human clinical trial conducted in the specific patient population with the disease or condition of interest intended to be studied in Phase III for the purposes of preliminary assessment of safety and efficacy, and selection of the dose regimen(s) to be studied in a Phase III Trial, as described under 21 C.F.R. §312.21(b), and that if the defined end-points are met, is sufficient to allow the Initiation of a Phase III Trial, or, with respect to a jurisdiction other than the United States, a similar clinical study.
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Phase IIb Trial. See “IND Trial”.
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Phase IIb Trial means a controlled dose ranging Phase II Trial to evaluate further the efficacy and safety of a candidate drug in the target patient population and to define the optimal dosing regimen.
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Phase IIb Trial and “Phase III Trial” shall have the following meanings:
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