Toxicology studies conducted under Good Laboratory Practice (GLP) are a crucial component of preclinical development, as their outcome drives the selection of the dosing range of subsequent first-in-human studies. While specific regulatory guidelines exist on the quality criteria of drug substance (DS) batches intended for clinical use, there are no such guidelines for preclinical DS. This document aims to provide a conceptual framework to achieve appropriate quality for DS batches used in GLP toxicology studies.
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