Phase 0 definition

Phase 0 means an exploratory, first-in-human trial conducted in accordance with the FDA 2006 Guidance on Exploratory Investigational New Drug Studies (or the equivalent in any country or other jurisdiction outside of the United States) and designed to expedite the development of therapeutic or imaging agents by establishing very early on whether the agent behaves in human subjects as was anticipated from pre-clinical studies.
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Phase 0 means that portion of Development which starts after a candidate has been selected and approved by BI or a Third Party licensee thereof for start of development as a product as evidenced by the approval in writing of such start of development by BI's International Steering Committee or equivalent body. Phase 0 generally includes toxicological and pharmacological studies as well as drug substance and drug product formulation and manufacturing development necessary to obtain the permission of regulatory authorities to begin and continue human clinical testing.
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Phase 0 means the preliminary project analysis and preparatory work required in order to gain access to SBIR/STTR Phase I.
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Examples of Phase 0 in a sentence

  • Advanced Text Analysis of Complaints Within sixty (60) days from the day following the signing of the Phase 0 compliance report, the supplier shall submit the following: • A report that must contain at least: - Models and tools used in the analysis.


More Definitions of Phase 0

Phase 0 means the first stage of the Project as described in this Agreement;
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Phase 0. Coordination Report at the end of the initial virtual meeting within seven (7) days of the beginning of the phase. Within fifteen (15) days from the day following the signing of the contract, the supplier shall submit the following deliverables virtually: • Service planning document. This document should include: - Provider's team contact details: Updated information on team members and their roles. - Work Breakdown Structure (WBS): Detail of tasks and subtasks required to complete the service. - Scheduled dates for results presentation meetings for each phase and training. - RACI Matrix: Assignment of responsibilities and roles for each task. - Security plan: Measures and procedures to ensure project security and protect confidential information. - Delivery of ten (10) users • Technical document on the platform. This document should include: - Platform structure: General description of the platform. - Technical architecture: Details about the technical infrastructure supporting the platform. - Components: Description of the elements that make up the platform. - User interface design: Mockups and details of the interface design. - Functionalities: Description of the main capabilities and functions of the platform. - Test plan: Strategy to verify and validate the platform. • Closing of the Phase document.
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Phase 0. Now until DAC 00/X0 00
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Phase 0. The test implementation phase of the radio system, in which Vancouver Police Department and Vancouver Fire Department are the only participants.
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Phase 0 means the Phase of the Project during which Developer will develop, construct, operate, and maintain the Temporary Facility.
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Phase 0. “Temporary Facility”: Developer will construct a temporary casino gaming facility of approximately 70,000 square feet in a “Sprung Structure,” accessory modular/prefabricated structures, suitable on-site parking facilities, site circulation drives, curbing and gutters, landscaping, and signage on the Development Property as designated on the Site Plan Documents and operate the Temporary Facility therein. Developer’s investment in the Temporary Facility will be no less than $20 million. Phase 0 Commencement: Construction of Phase 0 will commence within 10 days of the earlier of (a) the execution of the Temporary Construction Easement; or (b) the Closing; provided, however, that in no event shall construction of Phase 0 commence prior to receipt of all required approvals of the IGB and the City. Developer will use commercially reasonable efforts to deconstruct and remove the Temporary Facility no later than 90 days after the opening of the Permanent Facility.
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Related to Phase 0

  • 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.

  • 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.

  • Project Completion means the date, as determined by the Division after consultation with the Recipient, that operation of the Project is initiated or is capable of being initiated, whichever comes first.

  • Development Work means any work carried out in relation to the physical construction of a mine;

  • System Impact Study means an assessment by the Transmission Provider of (i) the adequacy of the Transmission System to accommodate a Completed Application, an Interconnection Request or an Upgrade Request, (ii) whether any additional costs may be incurred in order to provide such transmission service or to accommodate an Interconnection Request, and (iii) with respect to an Interconnection Request, an estimated date that an Interconnection Customer’s Customer Facility can be interconnected with the Transmission System and an estimate of the Interconnection Customer’s cost responsibility for the interconnection; and (iv) with respect to an Upgrade Request, the estimated cost of the requested system upgrades or expansion, or of the cost of the system upgrades or expansion, necessary to provide the requested incremental rights. System Protection Facilities: “System Protection Facilities” shall refer to the equipment required to protect (i) the Transmission System, other delivery systems and/or other generating systems connected to the Transmission System from faults or other electrical disturbance occurring at or on the Customer Facility, and (ii) the Customer Facility from faults or other electrical system disturbance occurring on the Transmission System or on other delivery systems and/or other generating systems to which the Transmission System is directly or indirectly connected. System Protection Facilities shall include such protective and regulating devices as are identified in the Applicable Technical Requirements and Standards or that are required by Applicable Laws and Regulations or other Applicable Standards, or as are otherwise necessary to protect personnel and equipment and to minimize deleterious effects to the Transmission System arising from the Customer Facility. Transmission Facilities:

  • 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 or “Phases” in respect of the Project shall mean that the components of the Project are placed in service during more than one year during the Investment Period, and the word “Phase” shall therefore refer to the applicable portion of the Project placed in service in a given year during the Investment Period.

  • 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.