Results 141 to 150 of about 7,937 (163)

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

Methods in Molecular Biology, 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 ...
Domenico Gadaleta, Emilio Benfenati, Fabiola Pizzo   +2 more
exaly   +3 more sources

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, S Niranjali Devaraj
exaly   +3 more sources

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 ...
David W Gaylor
exaly   +3 more sources

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
exaly   +3 more sources

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

Methods in Molecular Biology, 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
Emilio Benfenati, Fabiola Pizzo
exaly   +3 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 ...
Fernando Pizarro, Manuel Olivares, Paula J. Robson   +2 more
exaly   +3 more sources

Estimation of acute oral toxicity using the No Observed Adverse Effect Level (NOAEL) from the 28 day repeated dose toxicity studies in rats

Regulatory Toxicology and Pharmacology, 2009
Acute systemic toxicity is one of the areas of particular concern due to the 2009 deadline set by the 7th Amendment of the Cosmetics Directive (76/768/EEC), which introduces a testing and marketing ban of cosmetic products with ingredients tested on animals.
Agnieszka Kinsner-Ovaskainen, Sebastian Hoffmann, Pilar Prieto   +2 more
exaly   +3 more sources

Do Similar Structures Have Similar No Observed Adverse Effect Level (NOAEL) Values? Exploring Chemoinformatics Approaches for Estimating NOAEL Bounds and Uncertainties

Chemical Research in Toxicology, 2020
Determination of the no observed adverse effect level (NOAEL) of a substance is an important step in safety and regulatory assessments. Application of conventional in silico strategies, for example, quantitative structure-activity relationship (QSAR) models, to predict NOAEL values is inherently problematic.
Chihae Yang, James F. Rathman, Tomasz Magdziarz, Aleksandra Mostrag, Sunil Kulkarni, Tara S. Barton-Maclaren   +5 more
openaire   +2 more sources

WITHDRAWN: The effects of fumonisin B1 at the No Observed Adverse Effect Level (NOAEL) and 5-times above on the renal histology and lipidome of rats

Food and Chemical Toxicology, 2022
Fumonisin B1 (FB1) mycotoxin was intraperitoneally (IP) administered at the No Observed Adverse Effect Level (NOAEL = 0.2 mg/kg BW/day as IP equivalent, "L") and 5-times above ("H") to male rats, in a controlled ("C"), 5-day study (n = 10/group, total n = 30). BW (bodyweight) of H rats decreased after day 4, kidney weight after 5 days.
András Szabó, Ali Omeralfaroug, Thomas Bjellaas, György Kövér, Janka Turbók, Melinda Kovács   +5 more
openaire   +2 more sources

The No-Observed-Adverse-Effect Level (NOAEL) of Baby Aloe Powder (BAP) for Nutraceutical Application Based Upon Toxicological Evaluation

Journal of Toxicology and Environmental Health, Part A, 2014
Aloe has been used in versatile herbal medications and nutraceuticals throughout history. Aloe is widely considered to be generally safe for humans and used globally. The effectiveness and pharmacological properties of aloe are dependent upon when the plant is collected.
Seung Jun, Kwack, Seon-Gil, Do, Young Woo, Kim, Yeon-Joo, Kim, Hyo-Min, Gwak, Hyun Jong, Park, Taehyun, Roh, Min Kyung, Shin, Seong Kwang, Lim, Hyung Sik, Kim, Byung-Mu, Lee   +10 more
openaire   +2 more sources