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Statistical Uncertainty in the No-Observed-Adverse-Effect Level

Toxicological Sciences, 1989
The no-observed-adverse-effect level (NOAEL) is a dose value that U.S. EPA reduces by uncertainty factors (UF) and modifying factors (MF) to obtain a reference dose (RfD) for input to regulatory decision making. Whether the true added risk at the NOAEL is below an acceptable level, however, is a source of statistical uncertainty itself.
K G, Brown, L S, Erdreich
openaire   +2 more sources

Is there a role for the no observed adverse effect level in safety pharmacology?

Journal of Pharmacological and Toxicological Methods, 2020
In nonclinical toxicology the highest dose or exposure without test article-related adverse effects, known as the No Observed Adverse Effect Level (NOAEL), is a variable that may be determined. In safety pharmacology the vast majority of the endpoints measured are quantitative numeric functional endpoints such as changes in heart rate, blood pressure ...
Mow, Tomas   +14 more
openaire   +3 more sources

True prediction of lowest observed adverse effect levels

Molecular Diversity, 2006
A database of structurally heterogeneous chemical structures with their experimental values of Lowest Observed Adverse Effect Levels (LOAELs) was modeled using graph theoretical descriptors. Variable selection for multiple linear regression (MLR) and linear discriminant analysis (LDA) was accomplished by the Internal Test Set (ITS) method in order to ...
R, García-Domenech   +2 more
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In Silico Models for Repeated-Dose Toxicity (RDT): Prediction of the No Observed Adverse Effect Level (NOAEL) and Lowest Observed Adverse Effect Level (LOAEL) for Drugs

2022
Many regulatory contexts require the evaluation of repeated-dose toxicity (RDT) studies conducted in laboratory animals. The main outcome of RDT studies is the identification of the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) that are normally used as point of departure for the establishment of health ...
Fabiola, Pizzo   +2 more
openaire   +2 more sources

No-Observed-Adverse-Effect Levels in Severity Data

Journal of the American Statistical Association, 1997
Abstract Toxicity data are often categorized by severity of response and dose level with the assumption that there is a tolerated dose below which there is no toxicity. For data from a controlled experiment, the largest observed dose at or below the tolerated dose is called the no-observed-adverse-effect level (NOAEL).
Takashi Yanagawa   +2 more
openaire   +1 more source

Integrated In Silico Models for the Prediction of No-Observed-(Adverse)-Effect Levels and Lowest-Observed-(Adverse)-Effect Levels in Rats for Sub-chronic Repeated-Dose Toxicity

Chemical Research in Toxicology, 2020
Repeated-dose toxicity (RDT) is a critical endpoint for hazard characterization of chemicals and is assessed to derive safe levels of exposure for human health. Here we present the first attempt to model simultaneously no-observed-(adverse)-effect level (NO(A)EL) and lowest-observed-(adverse)-effect level (LO(A)EL). Classification and regression models
Domenico Gadaleta   +7 more
openaire   +2 more sources

Determination of an Acute No-Observed-Adverse-Effect Level (NOAEL) for Copper in Water

Regulatory Toxicology and Pharmacology, 2001
A prospective, double-blind controlled study was designed to determine the acute no-observed-adverse-effect level (NOAEL) of nausea in an apparently healthy population of 179 individuals who drank copper-containing water as the sulfate salt. Subjects were recruited at three different international sites and given a blind, randomly selected dose (0, 2 ...
M, Araya   +9 more
openaire   +2 more sources

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