Phase II definition

Phase II means the second part of the tuition incentive assistance program which provides assistance in the third and fourth year of 4-year degree programs.

Phase II means the acid rain program period beginning January 1, 2000, and continuing into the future thereafter.

Phase II means a human clinical trial of a Licensed Product, 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 pivotal clinical trials, or a similar clinical study prescribed by the Regulatory Authorities, 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.

Examples of Phase II in a sentence

• Hatchery production commitments, except for original inundation compensation, shall be adjusted based upon the results of survival studies conducted during Phase I, Phase II and Phase III (Standard Achieved, Additional Juvenile Studies, and Provisional Review).

• If the increased bypass flows implemented under Phase II (Interim Tools) do not achieve either 95% Juvenile Dam Passage Survival or 93% Juvenile Project Survival, the District shall proceed to Phase II (Additional Tools).

• Until the pertinent survival standard is achieved, the Parties shall continue to implement Phase II (Additional Tools) for the standard and for each Plan Species that is not meeting the pertinent survival standard, except as set forth in sub- Section 2.2.1 (Enough Already) and sub-Section 2.2.4 (Impossibility).

• If the survival standard remains un-achieved over three years of re- evaluation, then Phase II (Interim or Additional Tools) will take affect for the species evaluated.

• If Juvenile Dam Passage Survival continues to be less than 95% and Juvenile Project Survival continues to be less than 91%, then the District shall proceed to Phase II (Additional Tools).

More Definitions of Phase II

Phase II shall have the meaning set forth in Section 6.3.2.

Phase II as defined in CC Docket 94-102. Phase II data includes XY coordinates, confidence factor and certainty.

Phase II means the period of the national acid rain

Phase II means human clinical trials conducted on a limited number of patients for the primary purpose of evaluation of both clinical efficacy and safety, and/or to obtain a preliminary evaluation of the dosage regimen, as more fully defined in 21 C.F.R. §312.21(b).

Phase II means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(b) conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including Phase IIa studies.

Phase II means the phase of human clinical trials for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients in the United States or a country other than the United States. Phase II specifically excludes that phase of human clinical trials commonly referred to as “Phase I” clinical trials, which are solely intended to determine safety but not definitive dosing and efficacy of a pharmaceutical.

Phase II and "Phase III" shall mean Phase I (or Phase ------- -------- --------- I/II), Phase II, and Phase III clinical trials, respectively, in each case as prescribed by the U.S. Food and Drug Administration or a corresponding foreign entity.