Toxicology Studies definition

Toxicology Studies means any toxicology studies that have been conducted by or for BLI with respect to the Active Ingredient.
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Toxicology Studies means any carcinogenicity study, genotoxicity study or other studies related to Carcinogenicity Assessment Committee (CAC) of the FDA review of Compound in non-human animals or in vitro required by the FDA or any other Competent Authority.
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Toxicology Studies means all toxicology and absorption, distribution, metabolism and elimination ("ADME") studies performed by ADOLOR in order to obtain Regulatory Approvals of New Product.
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Examples of Toxicology Studies in a sentence

  • Ionis will submit invoices to Praxis for (a) the amount that is [***] of the total amount of the IND-Enabling Toxicology Costs promptly following Ionis’ execution of the contract with the applicable vendor for any IND-Enabling Toxicology Study, and (b) the remaining amount of such IND-Enabling Toxicology Costs once Ionis sends to Praxis the Draft Report with respect to such IND-Enabling Toxicology Studies.

  • If requested by Xxxxxxx, Poseida will allow representatives of Xxxxxxx to accompany Poseida as part of any audit Poseida conducts of the contract lab Poseida intends to use to conduct the IND-Enabling Toxicology Studies for the first Licensed Product for which Xxxxxxx exercises its Option.

  • 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.

  • Agensys may replace up to three (3) Research Stage Targets for Valid Scientific Reasons prior to the initiation of IND-Enabling Pharmacology and Toxicology Studies for a Compound with Primary Activity against a particular Research Stage Target pursuant to the procedure set forth in this Section 2.1.3(a).

  • Once available to Roche, Roche will promptly deliver to Isis the pharmacology, toxicology, histology and pharmacokinetic data generated from the IND-Enabling Toxicology Studies under the Brain Shuttle Development Candidate-R&D Plan.

  • After the completion of GLP Toxicology Studies, BIND and Amgen shall cooperate to transition the Manufacturing of Licensed Candidates and Licensed Products to a mutually acceptable Third Party manufacturer; provided that, if the Parties are unable to so agree, Amgen may select either Patheon or Xxxxxx as the Third Party manufacturer.

  • The cost to perform such work leading up to the IND-Enabling Toxicology Studies will be paid by Roche in accordance with Section 1.8.3 below.

  • ALNYLAM shall fund and be responsible for conducting all research and development of MERCK RNAi Novel Targets for discovery and development of RNAi Therapeutic Products as set forth herein and in the workplan developed pursuant to Section 2.14.1 through the completion of IND-Enabling GLP Toxicology Studies, at which time MERCK may exercise its Opt-In Right as set forth below.

  • For the second and any subsequent Isis Development Candidates, subject to Section 1.5.2(e), Roche will have the final decision-making authority regarding whether to Initiate the IND-Enabling Toxicology Studies and all subsequent Development activities thereafter.

  • Except as set forth in any Program Plan or Supply Agreement, MTEM shall not conduct any GLP Toxicology Studies or perform any other Development activities or Manufacturing activities with respect to any SLT-A Fusion Proteins prior to the expiration of all Option Periods hereunder, and then only with respect to Targets other than the Takeda Targets that have not been [***] Replacement Target or otherwise terminated as a Takeda Target .


More Definitions of Toxicology Studies

Toxicology Studies means IND-enabling good laboratory practices toxicology studies.
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Toxicology Studies means all toxicology studies necessary to submit an NDA for a Licensed Product.
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Toxicology Studies means all toxicology and absorption, distribution, metabolism and elimination (ADME) studies which are needed to register Products in the Territory.
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Toxicology Studies means all toxicology and absorption, distribution, metabolism and elimination (“ADME”) studies performed by Adolor in order to obtain Regulatory Approvals of Licensed Product.
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Toxicology Studies means all toxicology and absorption, distribution, metabolism and elimination (ADME) studies which are needed to conduct Clinical Trials and apply for Regulatory Approval with respect to a Product in the Territory.
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Related to Toxicology Studies

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • 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;

  • Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • 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 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.

  • 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 I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • 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.

  • 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 Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects 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 trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • 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.