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.
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.
Phase 0 means the preliminary project analysis and preparatory work required in order to gain access to SBIR/STTR Phase I.
Examples of Phase 0 in a sentence
Only those Competitor Teams that pass the Phase 0 or the Phase 1 Safety Review may proceed to the Phase 2 Safety Review.
The above shall be without prejudice to Concessionaire’s obligation to provide relevant Healthcare Services on “as is where is” basis in the Existing Hospital till COD of Phase 0, whereupon, all obligations shall apply with full force and affect.
Only the top 5 winners of GT-1 and GT-2 will be submitted to Phase 0 and Phase 1 Safety Reviews, respectively.
Variation of conditions 2 (plans), 28 (Phasing), 30 (building heights), 32 (Residential Construction Standards), 33 (Non-Residential Construction Standards), 38 (Landscape Habitat Management Strategy), 46 (Archaeology), 57 (Entrance works), 63 (Phase 0 Masterplan), and 71 (Phase 1 Masterplan) and removal of condition 58 (Pioneer Junction works) of 16/01802/OUT.
Xxxx & Xxxx, 12th Floor, Wisma Merdeka Phase 0, Xxxxx Xxx Xxxxx, 00000 Xxxx Xxxxxxxx, Xxxxx.
More Definitions of Phase 0
Phase 0. CReaTIVe bRIef: delivered in 3 business days Phase I: OUTLINe & hIeRaRChY: delivered in 5 business days Phase II: DesIgN: delivered in 12 - 18 business days Total fixed fee for project: $3,500 Deposit due: $1,750, 50% of agreed upon fee, due at time of agreement signing Balance: $1,750, 50% due date of delivery Total fixed fee for service: $85/year Monthly updates to server language, code, and integrations: $25/month Fee adjustments may be made due to rush delivery requests or prompt payment, as follows: Urgent delivery requires a price increase of 30% of the total fixed fee defined above. If full fee is paid on date of deposit, HSI shall receive a 5% discount on fees stated above. + Home - Includes up to 3 sliders to direct and highlight information - History - Accreditation - Administrative Team - governance - employment Opportunities + Online Application (Allows submission of employment application delivered via email to administrator) + Current Job Listings (Includes google document placement, updates information as submitted - or static PdF) - Contact Information + Facilities: - Autaugaville Family Health Center - Capital Family Health Center - Xxxxxxxx Family Health Center - Clanton Family Health Center - eclectic Family Health Center - Hayneville Family Health Center - Montgomery Primary Care Health Center - Xxxxx Family Health Center - River Region Health Center - Southside Family Health Center - Mobile Unit - wellness Center + Physicians: Find a Provider (Includes 25 Physician Bios with contact information & clinic locations) + Calendar of events (Includes google Calendar placement, updates information as submitted) + Search Bar (Allows search for all information on website, including location and provider names) Upon agreement, Avant Creative requests that all documentation be provided for content use by HSI, including artwork and imagery, using the following methods and formats. All content may be submitted to your Avant Creative Project Manager, Xxxxxxx Xxxxx, via e-mail: xxxxxxx@xxxxx-xxxxxxxx.xxx. - Pms and Web hex numbers for all primary, secondary, and tertiary color swatches. - example of use of Logo with wide, stacked, and single image variations. - headline and body Copy sizes, established both together and separately, should include font size, color variations acceptable, and body size along with leading and kerning if applicable. A paragraph formed with Headlines of various sizes and uses along with body copy placement should be submit...
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.
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. Now until DAC 00/X0 00
Phase 0. The test implementation phase of the radio system, in which Vancouver Police Department and Vancouver Fire Department are the only participants.
Phase 0 means the Phase of the Project during which Developer will develop, construct, operate, and maintain the Temporary Facility.