Level

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Related to NOAEL: LOAEL

Level

Used in the context of general equities. Price measure of an indication.
References in periodicals archive ?
One has to keep in mind that the no-observed-adverse-effect level (NOAEL) is only a proxy of the "true" no-adverse-effect level (NAEL), which will remain unknown.
(iii) A NOAEL of 800 mg/kg bw/ day--highest tested dose--was estimated in the 90-day study.
Chronic exposure to xenobiotics or pesticides often occurs at the no-observed-adverse-effect-level (NOAEL), which is the highest level of continuous exposure to a chemical that does not cause a significant adverse effect to the morphology, biochemistry, functional capacity, growth or lifespan of individuals of a species (85).
However, clinical hold may be experienced due to some reasons; for example, the duration of toxicology studies could be insufficient to support proposed clinical duration; doses/exposures may not be high enough in toxicology studies (according to ICH M3R2), or NOAEL not established in toxicology studies.
The IOM panel set the No Observed Adverse Effects Level (NOAEL) at 10,000 IU/day (3).
The no-observed-adverse-effect level (NOAEL) for the 28-day study was determined to be 2000 mg/kg body weight/day.
Toxicologists inform such decisions by measuring responses to progressively lower dosages of a substance until reaching an amount with no observable adverse effect level (NOAEL) on a test subject.
In general, chemicals are tested at high-effective doses and safe levels are established based on downward extrapolation of the lowest observed adverse effect level (LOAEL) or the no observed adverse effect level (NOAEL) obtained from examining a few endpoints in a limited number of animals.
Health Canada recognized that a "number of reproductive and developmental studies provide evidence that in utero and/or neonatal exposure to doses below the established reproductive/developmental NOAEL [no observable adverse effect levels] may result in altered reproductive function and developmental endpoints." (111) As for developmental neurotoxicity, it was reported that "in utero, perinatal or postnatal exposure to [BPA], at levels below the established NOAELs ...
(11) The results indicated an oral NOAEL for fresh-pressed E.
two 90-day sub-chronic oral studies (one for each species for which there is a range-finding study) to establish an MTD and a NOAEL (no observable adverse effect level) for use in calculating the margin of safety;