Treatability study means a study in which a hazardous waste is subjected to a treatment process to determine: (1) Whether the waste is amenable to the treatment process, (2) what pretreatment (if any) is required, (3) the optimal process conditions needed to achieve the desired treatment, (4) the efficiency of a treatment process for a specific waste or wastes, or (5) the characteristics and volumes of residuals from a particular treatment process. Also included in this definition for the purpose of the § 261.4 (e) and (f) exemptions are liner compatibility, corrosion, and other material compatibility studies and toxicological and health effects studies. A “treatability study” is not a means to commercially treat or dispose of hazardous waste.
Phase 1 means the phase of the ATP comprised of: (1) improvements to the State Street Substation; (2) construction of the Proposed Line; (3) the rebuilding of NYSEG’s existing Lines 971 and 000 xxxxx xx Xxxxxxxx Xxxx xx the NYSEG ROW to allow for construction of the Proposed Line as intended; (4) improvements to the Elbridge Substation to accept the Proposed Line; and (5) National Grid’s conveyance to NYSEG of the NYSEG Acquired ROW and such other land interests as contemplated by the Purchase and Sale Agreement.
conformity assessment means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;
Phase III means Phase I (or Phase I/II), Phase II (or Phase II/III) and Phase III clinical trials, respectively, in each case as prescribed by applicable FDA IND Regulations, or any corresponding foreign statutes, rules or regulations.
Study Completion means the database for the Study has been locked and all Essential Documents have been provided to the Sponsor, including a copy of the letter from the Reviewing HREC acknowledging receipt of the final report and/or closure letter from the Principal Investigator.
Feasibility Study means the evaluation and analysis of the potential of a project, which aims at supporting the process of decision-making by objectively and rationally uncovering its strengths and weaknesses, opportunities and threats, as well as identifying the resources required to carry it through and ultimately its prospects for success;
Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).
Corrective Measure means a measure as defined in Article 3, point 16, of Regulation (EU) 2019/1020;
Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.
Phase 2 Clinical Trial means a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(b), as amended, and is 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 in a country other than the United States.
Phase I means the first part of the tuition incentive assistance program defined as the academic period of 80 semester or 120 term credits, or less, leading to an associate degree or certificate.
Root Cause Analysis Report means a report addressing a problem or non-conformance, in order to get to the ‘root cause’ of the problem, which thereby assists in correcting or eliminating the cause, and prevent the problem from recurring.
Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.
Study means the investigation to be conducted in accordance with the Protocol.
Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.
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.
Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:
Phase 2 means the phase of the ATP comprised of: (1) improvements to the State Street Substation to receive Rebuilt Line 972; (2) the rebuilding of NYSEG’s existing Line 972 not performed in Phase 1; (3) construction of Relocated Line 15; (4) the construction of Bused Line 5; (5) improvements to the Elbridge Substation to receive Relocated Line 15; and (6) improvements to the Elbridge Substation to receive Bused Line 5.
Phase IV Clinical Trial means a Clinical Trial conducted after Regulatory Approval of the applicable Product has been obtained from an appropriate Regulatory Authority as a condition to, or for the maintenance of, any Regulatory Approval, including a trial that would satisfy the requirements of 21 C.F.R. 312.85, as may be amended, or the foreign equivalent thereof.
Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;
Phase II Clinical Trial means a controlled human clinical study 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 a Phase IIA Clinical Study or Phase IIB Clinical Study.
conformity assessment body means a body that performs conformity assessment activities including calibration, testing, certification and inspection;