Results 241 to 250 of about 3,155,563 (287)

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, J V, de Julián-Ortiz, E, Besalú   +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, Domenico, Gadaleta, Emilio, Benfenati   +2 more
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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, Yasuki Kikuchi, Kenneth G. Brown   +2 more
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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, M C, McGoldrick, L M, Klevay, J J, Strain, P, Robson, F, Nielsen, M, Olivares, F, Pizarro, L A, Johnson, K A, Poirier   +9 more
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Assessment of the no-observed-adverse-effect level (NOAEL) of gallic acid in mice

Food and Chemical Toxicology, 2001
Gallic acid is a naturally occurring plant phenol obtained by the hydrolysis of tannins and is known to show some pharmacological activities. The purpose of this paper is to establish the safety of gallic acid in mice. In this study, acute administration of gallic acid even at a dose as high as 5 g/kg body weight did not produce any signs of toxicity ...
K, Rajalakshmi, H, Devaraj, S, Niranjali Devaraj   +2 more
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Statistical issues on the determination of the no‐observed‐adverse‐effect levels in toxicology

Environmetrics, 2001
AbstractThe determination of a safe exposure level for toxic agents, often defined as the highest dose level with no toxic effect and termed the no‐observed‐adverse‐effect level (NOAEL) is reviewed. The conventional methods based on statistical tests are criticized, particularly when the sample size is small, and an alternative method, which is based ...
Takashi Yanagawa, Yasuki Kikuchi
openaire   +1 more source

Evaluation of the No Observed Adverse Effect Level of Solvent Dimethyl Sulfoxide in Drosophila melanogaster

Toxicology Mechanisms and Methods, 2003
Dimethyl sulfoxide, a solvent commonly used in toxicological studies, was investigated for its cytotoxic potential and its effect on development and reproductive performance in transgenic Drosophila melanogaster (hsp70-lacZ) Bg 9. Various concentrations (0.0, 0.1, 0.3, 0.5, 1.0, 2.0, and 3.0%) of the solvent were mixed with food and fed to the flies ...
Aamir, Nazir, Indranil, Mukhopadhyay, D K, Saxena, D Kar, Chowdhuri   +3 more
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Incidence of developmental defects at the no observed adverse effect level (NOAEL)

Regulatory Toxicology and Pharmacology, 1992
Bioassay data from Teratology, Vol. 1 (1968) through Vol. 40 (1990), were utilized which were sufficient to establish no observed adverse effect levels (NOAEL's) for 120 experiments on 93 developmental toxicants in animals. The observed incidence (risk) at the NOAEL was calculated as the proportion of affected fetuses minus the proportion affected in ...
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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

2016
The preclinical stage in drug development requires the determination of repeated-dose toxicity (RDT) in animal models. The main outcome of RDT studies is the determination of the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL). NOAEL is important since it serves to calculate the maximum recommended starting
Fabiola, Pizzo, Emilio, Benfenati
openaire   +2 more sources

The no-observed-adverse-effect-level in drug safety evaluations: Use, issues, and definition(s)

Regulatory Toxicology and Pharmacology, 2005
The no-observed-adverse-effect-level (NOAEL) is an important part of the non-clinical risk assessment. It is a professional opinion based on the design of the study, indication of the drug, expected pharmacology, and spectrum of off-target effects. There is no consistent standard definition of NOAEL. This is based, in part, on the varied definitions of
Michael A, Dorato, Jeffery A, Engelhardt
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