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).
Phase 3 means a controlled or uncontrolled human clinical trial of a compound or product that would satisfy the requirements of 21 CFR 312.21(c) or its foreign equivalents.
Phase 3 shall have the meaning set forth in Section 1.4.
Examples of Phase 3 in a sentence
Any data provided to Collaborator(s) for Phase 3 studies must be in accordance with the guidelines and policies of the responsible Data Monitoring Committee (DMC), if there is a DMC for this clinical trial.
The IC Identification Data must provide a unique identification of the IC during Phase 2 “Manufacturing” and Phase 3 “Personalization of the MRTD”.
The approved Phase 3 remediation works shall be carried out in full on site under a quality assurance scheme to demonstrate compliance with the proposed methodology and best practice guidance.
These test-pit excavations may require further excavations if the site is of significance (Phase 3).
MDRRMO misting team conducted operation on Phase 3 Heritage Homes, Brgy.
More Definitions of Phase 3
Phase 3 means a human clinical trial of a Molecule or Product on a sufficient number of subjects in an indicated patient population that is designed to establish that such Molecule or Product is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Molecule or Product, including all tests and studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(c), as amended.
Phase 3 means the third phase of human clinical trials of a drug required by the FDA or other equivalent regulatory authority to gain evidence of efficacy in the target population and obtain expanded evidence of safety for Product(s), as described in 21 C.F.R. Part 312, as it may be amended.
Phase 3 means that portion of the drug development and review process in which expanded clinical studies are conducted to gather the additional information to establish the effectiveness and safety that is needed to satisfy the requirements of a pivotal trial for obtaining regulatory approval to market an investigational new drug, as more specifically defined by the rules and regulations of the FDA or a similar regulatory requirement in any national jurisdiction.
Phase 3 means a human clinical trial of a Licensed Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a or Licensed Product is safe and efficacious For its intended use and to determine the benefit/risk relationship, warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Licensed Product, including all tests and studies that are required by the FDA from time to time, pursuant to applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(c), as amended.
Phase 3. Fees associated with custom engineering, implementation, as well as Corillian's expenses, shall be paid on an as incurred monthly basis.,
Phase 3 and means with regard to other countries a pivotal multi-center human clinical trial in a large number of patients to establish safety and efficacy in the particular claim and indication tested and required to obtain a Regulatory Approval.
Phase 3 means, with respect to a drug candidate, that portion of the clinical development program which provides for clinical trials of a drug candidate in patients for the purpose of establishing safety and efficacy of one or more particular doses in patients being studied, and which will (or are intended to) satisfy the requirements of a pivotal trial for purposes of obtaining approval of a product in a country by the health regulatory authority in such country to market such product, as more fully described in 21 C.F.R. § 312.21(c), or its successor regulation, or the equivalent in any foreign country.