Phase 2 Clinical Study means a human clinical study 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 Study” means a human clinical study that satisfies the requirements of 21 C.F.R. § 312.21 (b).
Phase 2 Clinical Study means a human clinical study that satisfies the requirements of 21 C.F.R. § 312.21 (b).
Phase 2 Clinical Study means a clinical study of a product that is designed to establish the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence pivotal clinical trials, as further defined in 21 C.F.R. § 312.21(b) (or the non-United States equivalent thereof).
Examples of Phase 2 Clinical Study in a sentence
In the event that a combined Phase 2 Clinical Study and Phase 3 Clinical Study is conducted for a Licensed Product, then Development and Regulatory Milestone Event A shall be deemed to be achieved when the fifth patient is dosed in the Phase 2 portion of the Clinical Study and Development and Regulatory Milestone Event B shall be deemed to be achieved when the fifth patient is dosed in the Phase 3 portion of the Clinical Study.
More Definitions of Phase 2 Clinical Study
Phase 2 Clinical Study means controlled human clinical studies conducted to evaluate the effectiveness of a drug 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 in compliance with 21 C.F.R. §312(b) or foreign equivalent, and shall include any clinical study that leads to a conditional regulatory approval, that is followed by a confirmatory Phase 3 Clinical Study.
Phase 2 Clinical Study means a study of a Licensed Product in human patients that is intended to obtain information on the Licensed Product’s activity for an indication at a prescribed (or otherwise limited) dose and administration schedule, as well as additional information on the Licensed Product’s safety and toxicity as and to the extent defined for the United States in 21 C.F.R. § 312.21(b), or its successor regulation, or the equivalent regulation in any other country. Without limiting the generality of the foregoing, a clinical study shall be deemed to be a “Phase 2 Clinical Study” hereunder if such study has been designated by the sponsor as a Phase 2 [II] clinical trial on xxx.xxxxxxxxxxxxxx.xxx (or any successor website maintained by the U.S. National Institutes of Health (or any successor agency of the U.S. Government)).
Phase 2 Clinical Study means that portion of the drug development and review process which provides for early controlled clinical studies conducted to obtain preliminary data on the effectiveness of an investigational new drug for a particular indication that would satisfy the requirements specifically defined by the rules and regulations of the FDA under 21 § C.F.R. 312.21(b), or similar rules and regulations in other countries or jurisdictions.
Phase 2 Clinical Study. Phase 2 Clinical Study shall mean a study of a Compound in patients to determine additional safety information and initial efficacy and dose range finding.
Phase 2 Clinical Study has the same meaning as set forth in 21 C.F.R. Section 312.21(b), including any and all amendments, modifications or changes thereto as may be made thereto in the future, or the equivalent thereof, in any applicable country within the Territory.
Phase 2 Clinical Study means a human clinical study of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and that is designed or intended 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, or a similar clinical study prescribed by the relevant Regulatory Authorities or Applicable Law in a country other than the United States.
Phase 2 Clinical Study means the second phase of a clinical study, the principal purpose of which is to evaluate the effectiveness of the drug for a particular indication and to determine the common short term side effects and risks associated with the drug in patients with the disease target being studied, that provides data capable of meeting statutory standards for marketing approval. Phase 2 studies usually involve no more than several hundred subjects. For example, “Phase 2 Clinical Study” includes a human clinical study that satisfies the requirements of 21 C.F.R. § 312.21(2) in the United States, or an equivalent or counterpart of the foregoing in any other country or jurisdiction.