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

  • DI DALAM PERJANJIAN JUAL BELI Penampang, Xxxxx XXXX ASAL) ALAMAT POS : Xxx X0-0, 0xx Xxxxx, Xxxxxxx Heights Apartments Phase 0, Xxxxx Xxxxxxxx-Xxxxxxx, Penampang, 88450 Kota Kinabalu, Sabah NO.

  • Xxx X0-0, 0xx Xxxxx, Xxxxxxx Xxxxxxx Apartments Phase 0, Xxxxx Xxxxxxxx-Xxxxxxx, Penampang, 88450 Kota Kinabalu, Sabah MASTER TITLE NO.

  • From completion and submission of the Phase 0 Concept document by Client, Developer will typically be able to generate a Concept Formula within 1-2 weeks, identify and request ingredient samples from suppliers within 1-3 weeks, receive ingredient samples from suppliers within 2-8 weeks, and the generate the Initial Bench-Top Sample within 1-2 weeks of receipt of ingredients from suppliers.

  • For the avoidance of doubt the total payable Phase 0 Fee and Phase 00 Fee will be equal to 10% of the Phase I/Phase II Project budget.

  • Client will outline the scope of the development project in the Wasatch NPD - Phase 0 Concept Development Questionnaire.docx supplied by Developer.


More Definitions of Phase 0

Phase 0 means the first stage of the Project as described in Section 1;
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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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Phase 0. Now until DAC 00/X0 00
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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 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 3 means the period commencing on the day after the Phase 2 implementation date and ending on the Phase 3 implementation date (as defined below).

  • Development Phase means the period before a vehicle type is type approved.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • 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 the conduct of preclinical and clinical trials, the compilation of the regulatory dossier concerning Licensed Products and the conduct of other work necessary or useful for obtaining Regulatory Approval of Licensed Products.

  • 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 3 Study means a clinical study of an investigational product in patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Marketing Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable Clinical Study prescribed by the relevant Regulatory Authority in a country other than the United States. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and a Phase 3 Study shall be deemed commenced when Initiated.

  • 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 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory 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.