Results 211 to 220 of about 1,885,648 (256)

A new approach to deriving community exposure guidelines from “no-observed-adverse-effect levels”

Regulatory Toxicology and Pharmacology, 1990
The world community desires accurate and reliable information about possible health hazards from exposure to chemicals in the environment. For example, Title III of the Superfund Amendments and Reauthorization Act (SARA, U.S. Congress, 1986) requires plant operators to disclose data on air, water, and waste emissions for over 300 chemicals.
S C, Lewis, J R, Lynch, A I, Nikiforov
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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, Andersen, Ninette K., Dragsted, Nils, Lassen, Anders B., Laursen, Morten, Bass, Alan S., Valentin, Jean Pierre, Markgraf, Carrie, Authier, Simon, Baird, Theodore J., Bhatt, Siddhartha, Traebert, Martin, Leishman, Derek J., Jones, David, Curtis, Michael J.   +14 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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Practical Considerations in Determining Adversity and the No-Observed-Adverse-Effect-Level (NOAEL) in Nonclinical Safety Studies: Challenges, Perspectives and Case Studies

International Journal of Toxicology, 2022
Determining the adverse nature of findings from nonclinical safety studies often poses a challenge for the key stakeholders responsible for interpreting the results of definitive toxicity studies in support of pharmaceutical product development. Although there are instances in which responses to treatment clearly indicate intolerability or tissue ...
Vijay P. Kale, Ilona Bebenek, Hanan Ghantous, John Kapeghian, Bhanu P. Singh, Lawrence J. Thomas   +5 more
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No-observed-adverse-effect level of hair pyrrole adducts in chronic n-hexane intoxication in rats

NeuroToxicology, 2020
n-Hexane has been reported to induce serious peripheral neuropathy in workers. Pyrrole adducts are the unique reaction products of n-hexane in organisms and have been demonstrated to be critical to n-hexane neuropathy. Our previous studies have demonstrated that pyrrole adducts could accumulate in hair and showed high correlation with neuropathy at the
Xianjie Li, Lulu Jiang, Ting Yu, Ming Li, Qiong Wang, Zhidan Liu, Keqin Xie   +6 more
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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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Developmental toxicity of carbendazim: comparison of no-observed-adverse-effect level and benchmark dose approach

Food and Chemical Toxicology, 1998
The benchmark dose (BD) approach has been applied to foetal data from four gavage segment II studies (rat studies 1 and 2, rabbit study, hamster study) on the teratogenic benzimidazole carbendazim. Nineteen parameters were assessed using the log-normal model as a practical tool to derive BDs; good model fitting was observed for all except two ...
A, Mantovani, F, Maranghi, C, Ricciardi, C, Macrì, A V, Stazi, L, Attias, G A, Zapponi   +6 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
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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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