GLP Tox Study definition

GLP Tox Study means, with respect to a Product, a study conducted in accordance with GLP for the purposes of assessing the efficacy, safety or the onset, severity, and duration of toxic effects and their dose dependency to establish a profile sufficient to support the filing of an investigational new drug application.
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GLP Tox Study means a toxicology study that is conducted in compliance with the then-current good laboratory practice standards promulgated or endorsed by the FDA, as defined in U.S. 21 C.F.R. Part 58 (as they may be updated from time to time) and is required to meet the requirements for filing an IND in the United States.
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GLP Tox Study means a toxicology study of the relationship between dose and its effects on the exposed animal, where (a) the study is to be conducted in accordance with GLP standards and (b) the study has been designed in expectation that the results may support establishment of a safe starting dose of the Product in Clinical Studies.
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Examples of GLP Tox Study in a sentence

  • 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.

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

  • A GLP Tox Study shall be started for a Product containing a Degronimid for which the JRD has determined that CCS Achieved has been reached.

  • For the avoidance of doubt, preliminary toxicology studies are not regarded as a GLP Tox Study.

  • The Parties shall form a Joint Development Committee (“JDC”) within [***] after the Initiation of the GLP Tox Study in the first species for a given Target to oversee all activities of a Phase I Plan of a Phase I Completed Original Product as well as clinical development of any C4T Co-Dev Products.

  • Drafting of the Phase I Plan shall be initiated prior to completion of a GLP Tox Study for such Phase I Completed Original Product.

  • During the Target Term with respect to Compounds Directed To a given Selected Target, except where otherwise set forth in the applicable Research Plan, Dicerna shall have responsibility at its own expense for the supply of Additional Dicerna Compounds for use in research activities conducted by Dicerna up to Initiation of GLP Tox Study for such Compound.

  • If either (i) a First CD71 PDC is determined to have satisfied the CD71 GLP Tox Success Criteria, or (ii) AbbVie, in its sole and absolute discretion, elects by written notice to Licensor to continue Development of a CD71 PDC that does not satisfy the CD71 GLP Tox Success Criteria, then Licensor shall commence a GLP Tox Study in accordance with the CD71 Initial Development Plan and Budget for the particular First CD71 PDC candidate selected by AbbVie.

  • The JRC and JDC (as applicable) shall meet promptly after submission of the Vividion Draft Preclinical Plan and Vividion Draft Clinical Plan to discuss such draft plans and establish the Preclinical Plan for activities up to Completion of the GLP Tox Study and the Clinical Plan, as applicable.

  • Notwithstanding anything to the contrary in the Platform Agreement, the Parties hereby agree that the initiation of the GLP Tox Study, as specified in Section 3.3 of the Platform Agreement, for the [***] Licensed Product will be deemed achieved on [***], such that SGEN will pay the milestone payment to PIRS for initiation of the GLP Tox Study for the [***] Licensed Product within [***] days after receiving the applicable invoice from PIRS on or after [***].


More Definitions of GLP Tox Study

GLP Tox Study means a non-clinical study conducted in accordance with GLP to characterize the toxicity profile of a drug by identifying its physiological impact through non-human testing, which may include an assessment of dose and reversibility of any adverse effects.
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GLP Tox Study means a toxicology study of the relationship between dose and its effects on an exposed animal (or its anticipated effects on humans where no animal is used in such a study, such as an organ-on-a-chip), where (i) the study is to be conducted in accordance with Good Laboratory Practices and (ii) the study has been designed in expectation that the results may support establishment of a safe starting dose of the Compound in Clinical Studies.
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GLP Tox Study means a pre-clinical study conducted in a species using applicable cGLP for the purposes of assessing the onset, severity, and duration of toxic effects and their dose dependency with the goal of establishing a safety profile required for a regulatory submission supporting the dosing of human subjects. For the avoidance of doubt, preliminary toxicology studies are not regarded as a GLP Tox Study. 1.59 “Governmental Authority” or “Government” means any United States (federal, state or local) government (or political subdivision thereof), or any foreign government (or political subdivision thereof), or any multinational governmental organization or authority, or any governmental authority, agency or commission, in each case, entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof), or any governmental arbitrator or arbitral body. 1.60 “IAS/IFRS” means International Accounting Standards/International Financial Reporting Standards of the International Accounting Standards Board, consistently applied. 1.61 “Incidence” means, with respect to any type or subtype of cancer (including a separate and distinct tumor type), for the Calendar Year preceding the applicable Calendar Year for which the “Incidence” is being measured, an incidence in the US of over 10,000 patient population (taking into account all stages of the applicable type or subtype) according to the incidence published by the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute (xxxxx://xxxx.xxxxxx.xxx/) or its substitute or successor statistic program as agreed to by the Parties, to establish the size of the treatable population in the US. 1.62 “IND” means an investigational new drug application, clinical trial authorization application, or similar application or submission (including any supplements of any of the foregoing) for approval to conduct human clinical investigations of a product filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority. 1.63 [ * ] 1.64 “Initial Merck Proprietary Product” means Merck’s (or its Affiliate’s) product pembrolizumab, a humanized anti-human PD-1 monoclonal antibody, that is primarily marketed as of the Effective Date under the tradename KEYTRUDA®, in any form, formulation, presentation or dosage strength. 1.65 “Initiated” or “Initia...
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GLP Tox Study means a toxicology study of a product (a) that is conducted in compliance with GLP regulations in an animal species appropriate to satisfy applicable regulatory requirements, (b) that is otherwise designed to satisfy applicable regulatory requirements and (c) the data and results from which are intended to support the filing of an IND for such product with the applicable Regulatory Authority. 11 [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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GLP Tox Study means a toxicology study on a Licensed Product the outcome of which is expected (if successful) to provide data sufficient to support the filing of an IND covering such Licensed Product. Such toxicology study, however, need not actually be successful in order to qualify as a GLP Tox Study.
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GLP Tox Study means, with respect to a Molecule, Clinical Candidate or a Product, an in vivo
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Related to GLP Tox Study

  • Phase I Trial means a clinical trial of a Product with the endpoint of determining initial tolerance, safety, pharmacokinetic or pharmacodynamic information in single dose, single ascending dose, multiple dose and/or multiple ascending dose regimens.

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

  • 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 Study means a clinical study of a drug candidate in human patients with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. §312.21(a), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase III Trial means a pivotal clinical trial of a Product on a sufficient number of patients, which trial is designed to (a) establish that a product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed; and (c) pivotal to support submission of a Regulatory Approval Application for such product.

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.