No-observed-adverse-effect level

The no-observed-adverse-effect level (NOAEL) denotes the level of exposure of an organism, found by experiment or observation, at which there is no biologically or statistically significant increase in the frequency or severity of any adverse effects of the tested protocol. In drug development, the NOAEL of a new drug is assessed in laboratory animals, such as mice, prior to initiation of human trials in order to establish a safe clinical starting dose in humans. The OECD publishes guidelines for Preclinical Safety Assessments, in order to help scientists discover the NOAEL.[1]

  1. ^ Deshpande, P.; Mohan, V.; Ingavale, D.; Mane, J.; Pore, M.; Thakurdesai Phd, P. (2017). "Preclinical Safety Assessment of Furostanol Glycoside-Based Standardized Fenugreek Seed Extract in Laboratory Rats". Journal of Dietary Supplements. 14 (5): 521–541. doi:10.1080/19390211.2016.1272659. PMID 28156165. S2CID 25932512.