Phase 1 Studies definition

Phase 1 Studies means a human clinical trial that would satisfy the requirements of United States 21 C.F.R. § 312.21(a), or a similar clinical study prescribed by the Regulatory Authorities in the EU or a country in the Harmony Territory outside the United States.
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Phase 1 Studies means a human clinical trial that would satisfy the requirements of United States 21 C.F.R. § 312.21(a).
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Phase 1 Studies means the additional scientific studies identified, implemented and managed by DOE and NYSERDA during Phase 1 of the Phased Decisionmaking Alternative in order to facilitate interagency consensus to complete decommissioning of the remaining facilities. According to ▇▇▇’▇ Record of Decision (ROD), the Phase 1 Studies may address uncertainties associated with the long-term performance models, the viability and cost of exhuming buried waste and tanks, the availability of waste disposal sites, and technologies for in-place containment. NYSERDA’s Findings Statement indicates that the studies should include, but not be limited to, analysis of soil erosion, groundwater flow and contaminant transport, engineered barriers, and uncertainty.
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Examples of Phase 1 Studies in a sentence

  • Bluebird will, at Celgene’s election, complete initial Phase 1 Studies for one (1) or more IND Product Candidates selected by Celgene, and, if Celgene elects not to have Bluebird complete any such Phase 1 Study, Bluebird may do so at its own expense.

  • Promptly following the Effective Date, the Parties will negotiate in good faith towards a supply agreement pursuant to which BIND will Manufacture or have Manufactured, Agreement Compounds for use in Phase 1 Studies (the “Supply Agreement”).

  • From the Effective Date through the initiation of Phase 1 Studies, BIND will have the sole right and obligation to Manufacture or have Manufactured, Agreement Compounds for the payment agreed to by the Parties as set forth in the Design/Preclinical Collaboration Plan.

  • A single oral dose of 60 mg has been tested in healthy volunteers in Phase 1 Studies WTX101-101, WTX101-102, and WTX101‑HV-106, and has been well tolerated.

  • Adolor shall be responsible for conducting ▇▇▇▇▇ ▇ ▇▇▇ ▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇ for each Licensed Product, provided, however, that Pfizer shall be responsible for conducting certain Phase 1 Studies for ADL 5859 and ADL 5747, as set forth in the Development Plan, and for completing the remaining pre-clinical toxicology and carcinogenicity studies for ADL 5859 and ADL 5747 including long-term toxicology and reproductive toxicology studies.


More Definitions of Phase 1 Studies

Phase 1 Studies a human clinical study of a product in any country, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, that would satisfy the requirements of 21 C.F.R. 312.21(a), or a similar clinical study prescribed by the relevant Regulatory Authorities or Applicable Law in a country other than the United States.
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Related to Phase 1 Studies

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Phase 1 Clinical Trial means, as to a specific pharmaceutical product, a Clinical Trial in humans of the safety of such product in healthy volunteers or a limited patient population, or human clinical studies directed toward understanding the mechanisms or metabolism of the product. A Phase 1 Clinical Trial shall be deemed initiated upon the dosing of the first subject or patient.

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory 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 relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase 1 Trial means, with respect to a Licensed Product, a clinical trial (or — in case of a multi-phase clinical trial — those parts of a clinical trial) in line with the provisions of 21CFR312, Section 21 (a).

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.