Phase 2 Clinical Trial

Example Definitions of "Phase 2 Clinical Trial"
Phase 2 Clinical Trial. Means a human clinical trial of a Product, the principal purpose of which is to evaluate the effectiveness of such Product in the target patient population, as described in 21 C.F.R. § 312.21(b), or a similar clinical study prescribed by the Regulatory Authorities in a country other than the United States. A Phase 2/3 trial shall be considered to be both a Phase 2 Clinical Trial and a Phase 3 Clinical Trial
Found in Repligen Corporation contract
Phase 2 Clinical Trial. Means a A human clinical trial of a Product, the principal purpose of which is to evaluate the effectiveness of such Product in the target patient population, as described in 21 C.F.R. § 312.21(b), or a similar clinical study prescribed by the Regulatory Authorities regulatory authorities in a country other than the United States. A Phase 2/3 trial shall be considered to be both a Phase 2 Clinical Trial and a Phase 3 Clinical Trial States
Found in ADIAL PHARMACEUTICALS, INC. contract
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Phase 2 Clinical Trial. Shall mean a human clinical trial in any country conducted to evaluate the effectiveness of a drug for a particular indication or indications in patients with the disease or condition under study and, possibly, to determine the common short- term side effects and risks associated with the drug. In the United States, "Phase 2 Clinical Trial" means a human clinical trial that satisfies the requirements of 21 C.F.R. § 312.21(b).
Found in TETRALOGIC PHARMACEUTICALS CORP contract
Phase 2 Clinical Trial. A Clinical Trial that is designed in a manner that is generally consistent with 21 CFR § 312.21(b)
Found in vTv Therapeutics Inc. contract
Phase 2 Clinical Trial. A clinical trial phase 2a, 2b or adaptive design for an indication in the Field that (a) occurs after a separate Phase 1 Clinical Trial for such indication, (b) is predominantly designed to evaluate clinical efficacy for a pharmaceutical product (and is not a clinical trial that is predominantly a safety study (e.g., a phase 1b/2a clinical trial)), in a manner that is generally consistent with 21 C.F.R. § 312.21(b), as amended (or its successor regulation) and/or any analogous applicable law... outside of the United States, as applicable, and (c) is necessary to enable Regulatory Approval in the United States or any Major European Country. View More
Found in Tarsus Pharmaceuticals, Inc. contract
Phase 2 Clinical Trial. Means a clinical trial phase 2a, 2b or adaptive design that is both (a) designed to evaluate clinical efficacy and safety for a pharmaceutical product, in a manner that is generally consistent with 21 C.F.R. § 312.21(b), as amended (or its successor regulation) and/or any analogous applicable law outside of the United States, as applicable, and (b) is necessary to enable Regulatory Approval in the United States or any Major European Country.
Found in Tarsus Pharmaceuticals, Inc. contract
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