Phase IIb Trial definition

Phase IIb Trial means a study of a Licensed Product in human patients to determine initial efficacy before commencing a Phase III Trial, which study is determined by Ocera or its Sublicensee to be a Phase IIb Trial.

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.

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.

Examples of Phase IIb Trial in a sentence

• A Randomized, Partially-Blinded, Multicenter, Active-Controlled, Dose-Ranging Study Assessing the Safety, Efficacy, and Pharmacodynamics of the REG1 Anticoagulation System in Patients with Acute Coronary Syndromes: The Design of the RADAR Phase IIb Trial.

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

• Role: Project lead)2006-2010CAPRISA 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 (USAID funding.

• A Phase I/Ib Trial of the VEGFR-Sparing Multikinase RET Inhibitor RXDX-105.

• A Phase IIa Trial is a Phase II Trial that is a human clinical trial in not less than 70 patients with the disease or indication under study and that is designed to provide an indication of the efficacy of the Licensed Product for its intended use, and a Phase IIb Trial is a Phase II Trial in patients with the disease or indication under study that is a well-controlled trial designed to be statistically significant.

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;

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.

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.

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.

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.

Phase IIb Trial and “Phase III Trial” shall have the following meanings:

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.