GLP Toxicity Study definition
GLP Toxicity Study means, with respect to a Product, a pre-clinical study conducted in a species using applicable GLP 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, as may be set forth in the Development Plan. For clarity, preliminary toxicity studies are not regarded as a GLP Toxicity Study.
GLP Toxicity Study means animal pharmacology and toxicology studies used to assess whether a Product is reasonably safe for initial testing in humans and to support IND filing.
GLP Toxicity Study means a study of the toxicological effects of a compound (including any of the Collaboration Leads) conducted in accordance with Good Laboratory Practices.