Toxicology studies conducted under Good Laboratory Practice (GLP) are a crucial element of preclinical development, as the resulting safety profile 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 Ardena Insight aims to provide a conceptual framework to achieve appropriate quality for DS batches used in GLP toxicology
studies.

Latest Resources

Our team members share deep, scientific understanding and insights into their respective fields of expertise.

Want to hear more from Ardena?

Sign up to receive drug development insights, the latest on industry trends & Ardena news.

Stay up to date with our latest news and announcements.
Get deep, scientific understanding and insights into our key fields of expertise.
See the events we're attending and register for webinars we're hosting.