Phase 2 Trial definition
Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).
Phase 2 Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(b) or corresponding foreign regulations.
Phase 2 Trial means that portion of the clinical development program that provides for a clinical trial of a product on patients, which may include pharmacokinetic studies, the principal purpose of which is to make a preliminary determination that such product is safe for its intended use, to determine potential doses and to obtain sufficient information about such product’s efficacy to permit the design of further clinical trials, and that is consistent with 21 CFR §312.21(b) or the applicable rules and regulations of the jurisdiction in which the clinical trial is conducted.
Examples of Phase 2 Trial in a sentence
If the Milestone Event for Initiation of a Phase 2 Trial for a Licensed Product set forth in Section 7.3.1(a) or Section 7.3.1(b) has failed to be achieved and BMS (or any of its Affiliates or Sublicensees) achieves the Initiation of a Registrational Trial, then such Milestone Event shall be deemed achieved and BMS shall pay to Avidity the Milestone Payment corresponding to Initiation of the Phase 2 Trial for a Licensed Product set forth in Section 7.3.1(a) or Section 7.3.1(b), as applicable.
More Definitions of Phase 2 Trial
Phase 2 Trial means a human clinical trial that would satisfy the requirements for a Phase 2 study as defined in 21 CFR § 312.21(b) (or its successor regulation);
Phase 2 Trial means a human clinical trial of a Product in any country that would satisfy the requirements of 21 C.F.R. § 312.21(b). For clarity, a trial called a Phase 1/2 or Phase 1b/2 trial shall be considered a Phase 2 trial if it satisfies the requirements of 21 C.F.R. § 312.21(b).
Phase 2 Trial means a human clinical trial of a Product, the principal purpose of which is a determination of preliminary short-term safety and efficacy in the target patient population, as described in 21 C.F.R. 312.21(b) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.
Phase 2 Trial means, as to a specific pharmaceutical product, a well conducted and lawful study, conducted anywhere in the world in diseased humans, of the feasibility, safety, dose ranging and efficacy of such product, that is prospectively designed to generate sufficient data (if successful) to commence a Phase 3 Trial (or foreign equivalent) of such product, as further defined in 21 C.F.R. 312.21(b), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States. For the avoidance of doubt, a Phase 2 Trial requires enrollment of patients with the applicable disease or condition and is aimed to provide a measure of efficacy in addition to short-term tolerability. A Phase 2 Trial shall be deemed initiated upon the enrollment of the first patient.
Phase 2 Trial means a Clinical Trial of a Licensed Product, including a separate Clinical Trial or the second part of a fused “Phase 1/2” Clinical Trial, on a sufficient number of subjects that is designed to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population.
Phase 2 Trial means, as to a specific Licensed Product, a clinical study, conducted anywhere in the world in diseased humans, of the feasibility, safety, dose ranging and efficacy of such Licensed Product, that is prospectively designed to generate sufficient data (if successful) to commence a Phase 3 Trial (or foreign equivalent) of such product, as further defined in 21 C.F.R. 312.21(b), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States. For the avoidance of doubt, a Phase 2 Trial requires enrollment of patients with the applicable disease or condition and is aimed to provide a measure of efficacy in addition to short-term tolerability.
Phase 2 Trial means a human clinical study that is intended to explore a variety of dose and dose response to generate initial evidence of clinical safety and activity in a target patient population for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) FDCA, as amended from time to time, or a foreign equivalent thereof.