GLP Toxicology definition

GLP Toxicology means a toxicology study that is commenced in compliance with GLP in a manner such that the resulting data would be admissible to applicable Regulatory Authorities to support an IND.
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GLP Toxicology means the first toxicology study commenced using GLP grade Licensed Product in an animal model to determine toxicology of said Licensed Product.
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GLP Toxicology means good laboratory practice toxicology studies.
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Examples of GLP Toxicology in a sentence

  • The Research Plan will set project priorities and define success criteria for a GLP Toxicology Candidate.

  • In general, the parties intend that ACADIA will be responsible for biology-related tasks relating to the ACADIA Targets and ArQule will be responsible for chemistry-related tasks relating to the ArQule Compounds, but only until identification of a GLP Toxicology Candidate.

  • A Product Development Plan for each Collaboration Compound for which AstraZeneca elects to commence GLP Toxicology Studies shall be prepared and approved as provided in Section 5.1.

  • Each Active Compound which meets the criteria set forth in Exhibit 2.3 to the satisfaction of the Research Committee may be recommended by the Research Committee to Dainippon which shall have the right to select from those so recommended the Active Compound for the GLP Toxicology Study and further development and commercialization under the License Agreement.

  • At the discretion of the Steering Committee, the parties may decide to conduct the necessary preclinical development activities to advance one or more GLP Toxicology Candidates to become IND Candidates, as described in the Collaboration Plan.

  • These preclinical development activities will continue with respect to a GLP Toxicology Candidate until the Research Committee and Steering Committee decide to stop further efforts.

  • If and when AstraZeneca decides to commence GLP Toxicology Studies for a Collaboration Compound, AstraZeneca shall notify Targacept in writing and the JDC shall prepare or direct the preparation of, and approve a Product Development Plan for such Collaboration Compound.

  • The parties will test these Analog Compounds for various properties determined by the Research Committee to predict whether the Committed Compound Set may eventually meet the defined success criteria for a GLP Toxicology Candidate.

  • Initiation of the first GLP Toxicology Study for a T1 Licensed Product $30,000,000 (Thirty Million Dollars) [***] [***] CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.

  • In no event shall a GLP Toxicology Study for a Compound be commenced prior to the determination by the JSC that such Compound satisfies the applicable Development Candidate Selection Criteria without the prior written consent of EISAI.

Related to GLP Toxicology

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Toxicologist means a qualified professional currently active in the field of risk assessment, risk management and toxicology that has a combination of formal university education, training and experience necessary to assess the Compound of Concern in question.