Phase 2 Study definition
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.
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 a Licensed Product in any country that would satisfy the requirements of 21 CFR 312.21(b) or corresponding foreign regulations.
Examples of Phase 2 Study in a sentence
Phase 2 Study in Immunocompromised Persons (HIV-positive adult subjects) (Africa) Study: Phase 2 study in immunocompromised persons (HIV-positive adult subjects) (Africa).
The Agreement concerns the performance of the Study in accordance with Radius Protocol No. BA058-05-007 “A Randomized, Double-Blind, Placebo Controlled, Phase 2 Study of BA058 Administered as a Coated Transdermal Microarray Delivery System (BA058 Transdermal) in Healthy Postmenopausal Women with Osteoporosis” (the “Protocol”).
This scope element will integrate the results defined in other NREL Phase 2 Study scope elements to the fullest extent practicable.
For clarity, a Pivotal Study may be a Phase 2 Study, a Phase 1/2 Study, or a Phase 3 Study.
Licensor will have the right, but no obligation, to conduct a Phase 2 Study to identify a safe and efficacious dose of the Lead Product for multiple sclerosis (a “Phase 2 MS POC Study”) in accordance with this Section 3.4.
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 Clinical Study of an investigational product in subjects with the primary objective of characterizing its activity in a specific disease state as well as generating more detailed safety, tolerability, pharmacokinetics, pharmacodynamics, and dose finding 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 Study (e.g., a Phase 1 Study/ Phase 2 Study).
Phase 2 Study means a clinical study of a drug candidate 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 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 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 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 includes any clinical study designated under an IPP as a “Phase 2 Study,” “Phase 2a Study,” Phase 2b Study,” “Phase 2 Trial,” Phase 2a Trial” or “Phase 2b Trial”.