Phase 2 Study means a human clinical trial of a compound or product for an Indication, the principal purpose of which is a determination of safety and efficacy for such Indication in the target patient population.
Phase 2 Study means a clinical study of a drug candidate in human patients with the primary objective of characterizing its activity in a specific disease state as well as generating more detailed safety, tolerability, and pharmacokinetics information as described in 21 C.F.R. §312.21(b), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States including a human clinical trial that is also designed to satisfy the requirements of 21 C.F.R. §312.21(a) or corresponding foreign regulations and is subsequently optimized or expanded to satisfy the requirements of 21 C.F.R. §312.21(b) (or corresponding foreign regulations) or otherwise to enable a Phase 3 Clinical Study (e.g., a phase 1/2 trial). The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.
Phase 2 Study means a human clinical trial of the Product, the principal purpose of which is a preliminary determination of safety and efficacy in the target patient population over a range of doses and dose regimens, as described in 21 C.F.R. § 312.21(b) (or its successor regulation) or the equivalent thereof in any jurisdiction outside the U.S.
Examples of Phase 2 Study in a sentence
This scope element will integrate the results defined in other NREL Phase 2 Study scope elements to the fullest extent practicable.
Phase 2 Study The primary objective of Phase 2 is to evaluate the efficacy of KTE-X19, as measured by the overall complete remission rate defined as complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) in adult subjects with r/r ALL (Appendix 1).
The Agreement allows for preliminary design work to begin on the project while the Biogas Utilization Phase 2 Study is completed.
Basic Information Study Name: San Leandro Bay Priority Margin Unit Study, Phase 2 Study Budget, Total: $100,000 SFEI Contact: • Technical – Xxx Xxxxx, xxx@xxxx.xxx, cell (000) 000-0000 • Financial – Xxxxxxxx Xxxxx, xxxxxxxx@xxxx.xxx, (000) 000-0000 Study Description Provide a concise description of the study, including the goal(s) of the study.
The DEFRA funded LEZ Phase 2 Study is an on-going study that will report at the end of November 2013, the LEZ Study is a key action within the Air Quality Action Plan (AQAP) for Sheffield 2015, which was approved at Cabinet on 11 July 2012.
More Definitions of Phase 2 Study
Phase 2 Study means a human clinical trial in any country that is conducted to evaluate the effectiveness of the PRODUCT IN CLASS 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 drug that would satisfy the requirements of 21 CFR 312.21(b), or other comparable regulation imposed by the FDA or its foreign counterpart.
Phase 2 Study means a human clinical trial with the principal purpose being a determination of safety and efficacy in the target patient population over a range of doses and dose regimens, as described in 21 C.F.R. § 312.21(b) (or its successor regulation) or the equivalent thereof in any jurisdiction outside the U.S.
Phase 2 Study means a Clinical Trial of a Licensed Product in patients with the primary objective of characterizing its activity in a specific disease state as well as generating more detailed safety, tolerability, and pharmacokinetics information as described in 21 C.F.R. § 312.21(b), or a comparable Clinical Trial prescribed by the relevant regulatory authority in a country other than the United States including a human Clinical Trial that is also designed to satisfy the requirements of 21 C.F.R. § 312.21(a) or corresponding foreign regulations and is subsequently optimized or expanded to satisfy the requirements of 21 C.F.R. § 312.21(b) (or corresponding foreign regulations) or otherwise to enable a Phase 3 Study (e.g., a phase 1/2 trial). The relevant Licensed Product may be administered to patients as a single agent or in combination with other investigational or marketed agents.
Phase 2 Study means a human clinical trial in the U.S. that would satisfy the requirements for a Phase 2 study as defined in 21 CFR § 312.21(b) (or any amended or successor regulations), or its substantial equivalence if such clinical trial is conducted outside the U.S.
Phase 2 Study means a clinical study of an investigational product in patients with the primary objective of characterizing its activity in a specific disease state as well as generating more detailed safety, tolerability, and pharmacokinetics information as described in 21 C.F.R. 312.21(b), or a comparable Clinical Study prescribed by the relevant Regulatory Authority in a country other than the United States including a human clinical trial that is also designed to satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations and is subsequently optimized or expanded to satisfy the requirements of 21 C.F.R. 312.21(b) (or corresponding foreign regulations) or otherwise to enable a Phase 3 Clinical Study (e.g., a phase 1/2 trial). The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and [***]
Phase 2 Study has the meaning set forth in Paragraph 1.5 (Schedule A).
Phase 2 Study means, wherever in the world conducted, a pilot clinical study in humans of the short-term side effects and risks associated with a product and its efficacy for the indication under investigation in such study, or that would otherwise satisfy the requirements of 21 C.F.R. § 312.21(b) in the U.S., or its foreign equivalent.