Phase II Study definition

Phase II Study means a human clinical trial, 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, and the foreign equivalent thereof.

Phase II Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) (as amended) (whether or not such trial is for the FDA), but which is not a Phase III Study or Phase IV Study.

Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

Examples of Phase II Study in a sentence

• Add: Construction Duration Construction duration outlined in the Phase II Study Report.

• The responsibility to finance the SCD mitigation(s) identified in the Phase II Study due to increases in SCD, shall be assigned pro rata to all projects requiring the SCD mitigation based on their respective SCD contribution.

• More specifically, thekey criteria applicable to this Phase II Study are as follows:• The thermal rating of any conductor, connector, or apparatus shall not exceed 100% of its normal rated capacity with all facilities in service (N-0 or base case).

• Identification of facility voltages (220 kV) in this Phase II Study are shown consistent with SCE System Operating Bulletin 123.

• Results or consequences of this Phase II Study may require additional studies, facility additions, and/or operating procedures to address impacts to neighboring utilities and/or regional forums.

More Definitions of Phase II Study

Phase II Study means (a) a dose exploration, dose response, duration of effect, kinetics, dynamic relationship or preliminary efficacy and safety study of a Product in the target patient population or (b) a controlled dose-ranging clinical trial to evaluate further the efficacy and safety of a Product in the target patient population and to define the optimal dosing regimen.

Phase II Study means a clinical trial that is designed to establish the safety and preliminary efficacy of a drug for its intended use, and to define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed and that satisfy the requirements of 21 CFR 312.21(b) (or its successor regulation), or its equivalent in any other jurisdiction.

Phase II Study means a study of a Licensed Product in humans, the principal purpose of which is a determination of safety and efficacy in the target patient population, which is prospectively designed to generate sufficient data that may permit commencement of a Pivotal Trial, or a similar Clinical Study prescribed by the relevant Regulatory Authority, from time to time, pursuant to applicable law or otherwise, including the trials referred to in 21 C.F.R. §312.21(b), as amended.

Phase II Study means a Phase II clinical trial as prescribed by applicable FDA regulations, or corresponding regulations of any comparable entity.

Phase II Study means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence Pivotal Studies, as further defined in 21 C.F.R. § 312.21(b) (or the non-United States equivalent thereof).

Phase II Study means a human clinical trial in any country or region that would satisfy the requirements of 21 C.F.R. 312.21(b) or the counterpart of it in such country or region, but which is not a Phase III Study or Phase IV Study.

Phase II Study means, collectively, a Phase IIa Study and a Phase IIb Study.