What is the difference between GLP and GLP tox?

The term GLP (Good Laboratory Practice) covers the overall framework of rules and quality standards that govern how non-clinical laboratory studies are performed and reported. GLP tox, on the other hand, refers specifically to toxicology studies conducted under GLP conditions. These studies evaluate the potential harmful effects of a drug, chemical, or biologic on living organisms before it enters clinical trials.

While all GLP tox studies must comply with the full GLP requirements, not all GLP studies are toxicology-based — some may focus on pharmacokinetics, stability, or method validation. GLP tox involves complex study designs, animal models, and safety endpoints, requiring meticulous documentation and Quality Assurance oversight. The goal is to generate data that regulatory authorities such as the EMA or FDA can fully trust. In essence, GLP is the quality framework, and GLP tox is its toxicological application that supports drug safety assessment and regulatory approval.