GLP Tox Study Clause Samples
The GLP Tox Study clause defines the requirements and standards for conducting toxicology studies in accordance with Good Laboratory Practice (GLP) regulations. It typically specifies that any preclinical safety studies, such as those assessing the toxicity of a drug candidate, must be performed in certified facilities following GLP guidelines to ensure data integrity and regulatory compliance. This clause ensures that the results of toxicology studies are reliable and acceptable to regulatory authorities, thereby supporting the safety evaluation process and facilitating the approval of new products.
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GLP Tox Study. The term “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.
GLP Tox Study. The term “
GLP Tox Study. Except for Products directed to [***], C4T shall be solely responsible for the conduct of GLP Tox Studies in a rodent and non-rodent species using a CRO approved by the Parties and listed on Appendix 4.1.8) following the JRC’s determination that CCS Achieved has been reached for a Degronimid for a given Target. 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. The study protocols for such GLP Tox Studies shall be mutually agreed by the Parties, and the Parties shall discuss and align via the JRC on drug substance and drug product specifications of Products used for such GLP Tox Studies.