Phase II Study definition

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).
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 intended to explore a variety of doses, dose response, and duration of effect, and to generate evidence of clinical safety and effectiveness for a particular Indication or Indications in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities, from time to time, pursuant to applicable Law or otherwise, including for example the trials referred to in 21 C.F.R. §312.21(b), as amended (or the non-United States equivalent thereof).

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.

  • This document has been prepared to identify the impact(s) contributions of the Generating Facility on the SCE electrical system; as well as establish the technical requirements to interconnect the Generating Facility to the POI that was evaluated in the Phase II Study for the Generating Facility.


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, in respect of a Sublicensed Product, (a) that portion of the FDA submission and approval process which provides for early controlled clinical studies conducted to obtain preliminary data on the effectiveness of a product for a particular indication, as more specifically defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21(b) or any future revisions or substitutes thereof; or (b) similar clinical study in any national jurisdiction other than the United States.
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 Phase II clinical trial as prescribed by applicable FDA regulations, or corresponding regulations of any comparable entity.
Phase II Study means, collectively, a Phase IIa Study and a Phase IIb Study.
Phase II Study means: (a) that portion of the FDA submission and approval process which provides for early controlled clinical studies conducted to obtain preliminary data on the effectiveness of a product for a particular indication, as more specifically defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21(b) or any future revisions or substitutes therefor; or (b) any clinical trial that obtains data regarding the efficacy of a product, including without limitation Phase Ib study of a product, a clinical study of a product consisting of a cohort expansion, or a combined Phase Ib/II clinical study of a product; or (c) a clinical study similar to the foregoing (a) or (b) in any jurisdiction other than the United States. For the avoidance of doubt, when the safety and tolerability of a product has been established through the conduct of a PHASE I STUDY, the next clinical trial of a product will be a PHASE II STUDY.
Phase II Study means the conduct of a human study, as described in 21 C.F.R. §312.21(b) and its foreign equivalents, of a Licensed Product, but excluding any Probe Study.