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 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 Licensed Product, including possibly pharmacokinetic studies, the principal purpose of which is to make a preliminary determination that such Licensed Product is safe in patients for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with Title 21, Section 312.21(b) of the CFR, or a similar clinical study in any other country.
Examples of Phase 2 Trial in a sentence
MPC-7869, a Selective Aβ42-Lowering Agent, Delays Time to Clinically Significant Psychiatric Adverse Events in Alzheimer’s Disease: Analysis from a 12-Month Phase 2 Trial (Mintzer); July 17, 2006 - ICAD 2006; Madrid, Spain 2 A Responder Analysis of Tarenflurbil (MPC-7869), a Selective Aβ42-Lowering Agent, in Mild Alzheimer's Disease(AD): Analysis from a Phase 2 Study of up to 24 months of Treatment (Zavitz).
More Definitions of Phase 2 Trial
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.
Phase 2 Trial means, with respect to a Product, a Clinical Study that is intended to explore the feasibility, safety, dose ranging or 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) or the corresponding regulation in jurisdictions other than the United States.
Phase 2 Trial means, with respect to a Product, a Clinical Trial that is intended to explore the feasibility, safety, dose ranging or efficacy of such Product, that is prospectively designed to generate sufficient data (if successful) to commence a Pivotal Clinical Trial (or foreign equivalent) of such Product, as further defined in 21 C.F.R. 312.21(b) or the corresponding regulation in jurisdictions other than the United States.
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 in any country that would satisfy the requirements of 21 C.F.R. § 312.21(b), or its foreign equivalent.
Phase 2 Trial means a human clinical trial that would satisfy the requirements for a Phase 2 study as defined in 21 C.F.R. §312.21(b) (or its successor regulation), or its foreign equivalent.
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 any foreign equivalent thereof.