GLP Tox definition

GLP Tox means a toxicology study that is conducted in compliance with Good Laboratory Practice [XXXXXXX].
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GLP Tox means toxicology studies carried out in accordance with Good Laboratory Practice, as described in 21 C.F.R. ss. 312 as revised, or the European equivalent.
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GLP Tox. Study The term “GLP Tox Study” shall mean a study in accordance with the Good Laboratory Practice (GLP) to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for a product.
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Examples of GLP Tox in a sentence

  • Notwithstanding the foregoing, uniQure shall be deemed to have accepted as a GLP Tox Compound any Research Compound that it advances into pre-clinical Development conducted under Good Laboratory Practices.

  • For clarity, in the event that Roche does not exercise its Option at GLP Tox Completion, Pharmasset shall not be required to conduct further development of such Potential Licensed Compound.

  • Subject to the terms and conditions of this Agreement, uniQure hereby grants to 4DMT, and 4DMT hereby accepts, during the Research Term and any applicable GLP Tox Candidate Review Period in effect as of the end of the Research Term, a non-exclusive, worldwide, royalty-free, non-sublicenseable license under the uniQure Intellectual Property, solely to the extent necessary to conduct activities assigned to 4DMT under the Research Plan.

  • Progress of up to […***…] Collaboration Compounds satisfying CCS Criteria through GLP Tox Studies for a Collaboration Target shall be at BPM’s sole expense.

  • Additional Backup Compounds may be progressed through a GLP Tox Study at Roche’s sole discretion and expense (including any supply thereof) as part of the Research Plan and under the supervision of the JRC, provided that BPM will have the right to conduct (or have conducted) any such GLP Tox Study, and if BPM elects such right then Roche shall reimburse BPM for any personnel costs, Allocable Overhead or Out of Pocket Expenses incurred by BPM with respect thereto.

  • Betty faced resistance at first from colleagues as she started the project; however, the collaborative approach adopted allowed her to gain the respect and collaboration of colleagues for the initiative.

  • The JDC shall strive by consensus to prepare a Phase I Plan for each Collaboration Target no later than thirty (30) days after the start of GLP Tox Studies for such Collaboration Target.

  • For the purposes of this Section 4.3.7, “Significant Study” shall mean any GLP Tox Study or Clinical Study.

  • In the event that Roche exercises its Option earlier than GLP Tox Completion, Pharmasset shall have no responsibility for any GLP Tox Completion activities that were not initiated prior to Roche’s exercise of its Option, and Roche shall assume such responsibility for the remaining GLP Tox Completion activities, to the extent that the JDMC determines that such activities are necessary for development of such Potential Licensed Compound.

  • Notwithstanding the foregoing, the Candidate Success Criteria shall be deemed to have been met for any Research Compound that uniQure advances into GLP Tox Studies.


More Definitions of GLP Tox

GLP Tox means a long-term safety study in the appropriate animal species (usually one rodent and one mammal) under the Good Laboratory Practices guidelines as described in 21 CFR Part 58 which design and results are suitable to support a filing of an IND.
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Related to GLP Tox

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • 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).

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • GLP means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and comparable foreign regulatory standards.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • 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).

  • 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 III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Development Milestone is defined in Section 5.3.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Pivotal Study means (a) a Phase 3 Study that is intended by Celgene to be submitted (together with any other registration trials that are prospectively planned when such Phase 3 Study is initiated) for Regulatory Approval in the U.S. or the EU, or (b) any other clinical study 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 clinical study is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such study.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • POC means Point of Compliance. "POE" means Point of Exposure. "PSI" means pounds per square inch.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.