Toxicity, chronic

The development of adverse effects as a result of long-term exposure to a drug.

Chronic toxicity testing characterizes the toxicological profile of a test compound following repeated administration in rodents and non-rodents. It is part of the safety evaluation of medicinal products to support the application requesting permission to conduct first in human clinical trials.

Repeated dose toxicity (EMA, 2010)

Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (FDA, 2010)

REVIVE Webinar: ‘Making Safety a Part of Drug Design’ by Claire Sadler (GARDP, 2018)