No observed adverse effect level (NOAEL)

Highest dose of a drug that does not produce a significant increase in adverse effects in comparison to a control group in clinical (human) or preclinical studies (animal).

Calculating NOAELs is an important aspect of risk assessment in drug development. Determining NOAEL values informs the choice of dose used in clinical trials.

Non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals (EMA, 2008)

Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (FDA, 2010)

A New Way in Deciding NOAEL Based on the Findings from GLP-Toxicity Test (Toxicological Research, 2011)

REVIVE Webinar: Making Safety a Part of Drug Design (GARDP, 2018)