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.
View Source
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.
View Source
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.
View Source

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.

  • 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.

  • 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.

  • 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.

  • Roche shall pay Dicerna’s fully burdened manufacturing costs for supply of Additional Dicerna Compounds as requested by Roche for use in activities that will occur after Initiation of GLP Tox Study, and otherwise Roche shall have responsibility at its own expense for the supply of all Compounds, in each case for use in the R&D Collaboration.

  • For avoidance of doubt, any supply of Additional Dicerna Compounds by Dicerna to Roche prior to the Initiation of GLP Tox Study for use in or after the Initiation of GLP Tox Study (including manufacturing reservation and cancelation fees incurred under the Research Plan), shall be reimbursed to Dicerna by Roche.

  • 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.


More Definitions of GLP Tox Study

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.
View Source
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 (▇▇▇▇▇://▇▇▇▇.▇▇▇▇▇▇.▇▇▇/) 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...
View Source
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.
View Source
GLP Tox Study means, with respect to a Molecule, Clinical Candidate or a Product, an in vivo
View Source

Related to GLP Tox Study

  • 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 Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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 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 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.