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Regulatory toxicology

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https://www.readbyqxmd.com/read/28329812/response-to-does-glp-enhance-the-quality-of-toxicological-evidence-for-regulatory-decisions
#1
Anthony C Tweedale
No abstract text is available yet for this article.
October 6, 2016: Toxicological Sciences: An Official Journal of the Society of Toxicology
https://www.readbyqxmd.com/read/28323104/cytotoxicity-and-genotoxicity-of-lipid-nanocapsules
#2
Gaël Le Roux, Hélène Moche, Alejandro Nieto, Jean-Pierre Benoit, Fabrice Nesslany, Frédéric Lagarce
Lipid nanocapsules (LNCs) offer a promising method for the entrapment and nanovectorisation of lipophilic molecules. This new type of nanocarrier, formulated according to a solvent-free process and using only regulatory-approved components, exhibits many prerequisites for being well tolerated. Although toxicological reference values have already been obtained in mice, interaction of LNCs at the cell level needs to be elucidated. LNCs, measuring from 27.0±0.1nm (25nm LNCs) and 112.1±1.8nm (100nm LNCs) and with a zeta potential between -38...
March 17, 2017: Toxicology in Vitro: An International Journal Published in Association with BIBRA
https://www.readbyqxmd.com/read/28322593/a-retrospective-analysis-of-the-added-value-of-1-year-dog-studies-in-pesticide-human-health-risk-assessments
#3
Brenda Linke, Sara Mohr, Deborah Ramsingh, Yadvinder Bhuller
The 1-year dog toxicity study is no longer required by certain pesticide regulatory jurisdictions, including the United States and the European Union. Health Canada's Pest Management Regulatory Agency (PMRA) examined its current requirement for this study to determine if it could be refined or eliminated. A retrospective analysis was conducted to examine the impact of the 1-year dog study on human health risk assessment. The Acceptable Daily Intake (ADI), a measure of the amount of a pesticide in food that can be ingested on a daily basis over a lifetime without an appreciable health risk, was the metric for this analysis...
March 21, 2017: Critical Reviews in Toxicology
https://www.readbyqxmd.com/read/28286286/cancer-immunotherapy-targeting-the-cd47-sirp%C3%AE-axis
#4
REVIEW
Kipp Weiskopf
The success of cancer immunotherapy has generated tremendous interest in identifying new immunotherapeutic targets. To date, the majority of therapies have focussed on stimulating the adaptive immune system to attack cancer, including agents targeting CTLA-4 and the PD-1/PD-L1 axis. However, macrophages and other myeloid immune cells offer much promise as effectors of cancer immunotherapy. The CD47/signal regulatory protein alpha (SIRPα) axis is a critical regulator of myeloid cell activation and serves a broader role as a myeloid-specific immune checkpoint...
March 9, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28286084/recent-experimental-results-of-effects-of-perfluoroalkyl-substances-in-laboratory-animals-relation-to-current-regulations-and-guidance-values
#5
Hellmuth Lilienthal, Hermann H Dieter, Jürgen Hölzer, Michael Wilhelm
The detection of perfluoroalkyl substances (PFAS) in surface and drinking water from various countries raised the attention to the presence of these chemicals in environmental probes and led to several regulatory actions to limit exposure in human beings. There was particular concern about perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), due to their former wide-spread use. Recently, several institutions published revisions of former regulatory or recommended maximum concentrations in drinking water and food, which are markedly lower than the former values...
March 2, 2017: International Journal of Hygiene and Environmental Health
https://www.readbyqxmd.com/read/28285934/human-exposure-to-chemical-mixtures-challenges-for-the-integration-of-toxicology-with-epidemiology-data-in-risk-assessment
#6
REVIEW
Antonio F Hernández, Aristidis M Tsatsakis
Little is known about the potential adverse effects from longterm exposure to complex mixtures at low doses, close to health-based reference values. Traditional chemical-specific risk assessment based on animal testing may be insufficient and the lack of toxicological studies on chemical mixtures remains a major regulatory challenge. Hence, new methodologies on cumulative risk assessment are being developed but still present major limitations. Evaluation of chemical mixture effects requires an integrated and systematic approach and close collaboration across different scientific fields, particularly toxicology, epidemiology, exposure science, risk assessment and statistics for a proper integration of data from all these disciplines...
March 7, 2017: Food and Chemical Toxicology
https://www.readbyqxmd.com/read/28257851/aldh2-deficiency-as-genetic-epidemiologic-and-biochemical-model-for-the-carcinogenicity-of-acetaldehyde
#7
Dirk W Lachenmeier, Mikko Salaspuro
Humans are cumulatively exposed to acetaldehyde from various sources including alcoholic beverages, tobacco smoke, foods and beverages. The genetic-epidemiologic and biochemical evidence in ALDH2-deficient humans provides strong evidence for the causal relationship between acetaldehyde-exposure due to alcohol consumption and cancer of the upper digestive tract. The risk assessment has so far relied on thresholds based on animal toxicology with lower one-sided confidence limit of the benchmark dose values (BMDL) typically ranging between 11 and 63 mg/kg bodyweight (bw)/day dependent on species and endpoint...
March 1, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28247928/advancing-alternatives-analysis-the-role-of-predictive-toxicology-in-selecting-safer-chemical-products-and-processes
#8
Timothy Malloy, Virginia Zaunbrecher, Elizabeth Beryt, Richard Judson, Raymond Tice, Patrick Allard, Ann Blake, Ila Cote, Hilary Godwin, Lauren Heine, Patrick Kerzic, Jakub Kostal, Gary Marchant, Jennifer McPartland, Kelly Moran, Andre Nel, Oladele Oguseitan, Mark Rossi, Kristina Thayer, Joel Tickner, Margaret Whittaker, Ken Zarker
Alternatives analysis (AA) is a method used in regulation and product design to identify, assess, and evaluate the safety and viability of potential substitutes for hazardous chemicals. It requires toxicological data for the existing chemical and potential alternatives. Predictive toxicology uses in silico and in vitro approaches, computational models, and other tools to expedite toxicological data generation in more cost-effective manner than traditional approaches. This article briefly reviews the challenges associated with using predictive toxicology in regulatory AA, then presents four recommendations for its advancement...
March 1, 2017: Integrated Environmental Assessment and Management
https://www.readbyqxmd.com/read/28231528/identification-of-uv-absorbing-extractables-from-rubber-closures-used-in-containers-of-injectable-powder-and-safety-assessment-of-leachables-in-the-drug
#9
Yulei Wei, Ying Wu, Tingli Zhu, Zhiyan Li, Yilan Zhang
Rubber closures have been of great concern to regulatory authorities on account of their potential safety risks to patients. The aim of our work is to provide part of data about the compatibility of the injectable powder and its packaging materials for the drug registration. In this report, methodologies were established to study the system of the preparation. Firstly, three major extractables were isolated by semi-preparative HPLC method combined with silica gel-based chromatographic methods. NMR spectra including 1D NMR ((1)H, (13)C, DEPT135) and 2D NMR (COSY, HSQC, HMBC) were introduced to identify the extractables, besides HPLC, GC-MS, ESI-MS/MS and HRMS...
February 16, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28218988/toxicological-effects-during-and-following-persistent-insulin-induced-hypoglycaemia-in-healthy-euglycaemic-rats
#10
Vivi F H Jensen, Anne-Marie Mølck, Line O Berthelsen, Lene Alifrangis, Lene Andersen, Melissa Chapman, Jens Lykkesfeldt, Ingrid B Bøgh
New insulin analogues with a longer duration of action and a "peakless" pharmacokinetic profile have been developed to improve efficacy, safety and convenience for diabetic patients. During non-clinical development, according to regulatory guidelines, these analogues are tested in healthy euglycaemic rats rendering them persistently hypoglycaemic. Little is known about the effect of persistent (24 hr/day) insulin-induced hypoglycaemia (IIH) in rats, complicating interpretation of results in pre-clinical studies with new longer-acting insulin analogues...
February 20, 2017: Basic & Clinical Pharmacology & Toxicology
https://www.readbyqxmd.com/read/28196426/development-of-a-functional-observational-battery-in-the-minipig-for-regulatory-neurotoxicity-assessments
#11
Miao Zhong, Catherine Shoemake, Amber Fuller, David White, Chris Hanks, Derek Brocksmith, Jason Liu, Shayne Gad, Guy Bouchard, Alain Stricker-Krongrad
A functional observational battery (FOB) is recommended as the first-tier neurotoxicity screening in the preclinical safety pharmacology testing guidelines. Minipigs have increasingly been used in regulatory toxicology studies; however, no current FOB protocol is available for neurotoxicity testing in these species. Hence, a minipig FOB instrument was developed. A complete crossover study with Sinclair minipigs was performed to evaluate physiologic, neurologic, and behavioral effects of amphetamine, ketamine, and diazepam...
January 1, 2017: International Journal of Toxicology
https://www.readbyqxmd.com/read/28192153/comparison-of-the-acute-inhibitory-effects-of-tetrodotoxin-ttx-in-rat-and-human-neuronal-networks-for-risk-assessment-purposes
#12
COMPARATIVE STUDY
Emma E J Kasteel, Remco H S Westerink
Tetrodotoxin (TTX) is an extremely toxic marine neurotoxin. TTX inhibits voltage-gated sodium channels, resulting in a potentially lethal inhibition of neurotransmission. Despite numerous intoxications in Asia and Europe, limited (human) toxicological data are available for TTX. Additionally, the degree of interspecies differences for TTX is not well established, hampering the use of available (animal) data for human risk assessment and establishing regulatory limits for TTX concentrations in (shell)fish. We therefore used micro-electrode array (MEA) recordings as an integrated measure of neurotransmission to demonstrate that TTX inhibits neuronal electrical activity in both primary rat cortical cultures and human-induced pluripotent stem cell (hIPSC)-derived iCell(®) neurons in co-culture with hIPSC-derived iCell(®) astrocytes, with IC50 values of 7 and 10nM, respectively...
March 15, 2017: Toxicology Letters
https://www.readbyqxmd.com/read/28189099/miniaturising-acute-toxicity-and-feeding-rate-measurements-in-daphnia-magna
#13
Konstantinos Grintzalis, Wenkui Dai, Konstantinos Panagiotidis, Alexia Belavgeni, Mark R Viant
Phenotypic markers of animal health form an essential component of regulatory toxicology. Immobilisation of neonate water fleas - Daphnia magna - as a surrogate measure of their mortality following exposure to a chemical for 24-48h forms the basis of the internationally utilised OECD acute toxicity test 202. A second important marker of animal physiology and health is feeding rate, which in Daphnia is determined by measuring the algae feeding rate. Given the widespread use of OECD test 202 for acute toxicity as well as the quantification of feeding rate in toxicological studies of daphniids, significant benefits could result from miniaturising this assay...
February 8, 2017: Ecotoxicology and Environmental Safety
https://www.readbyqxmd.com/read/28184298/recent-advances-in-understanding-assessing-toxicity-to-the-epigenome
#14
REVIEW
Kevin Sweder
The ability of non-genotoxic agents to induce cancer has been documented and clearly requires a reassessment of testing for environmental and human safety. Drug safety testing has historically relied on test batteries designed to detect DNA damage leading to mutation and cancer. The standard genetic toxicology testing battery has been a reliable tool set to identify small molecules/chemicals as hazards that could lead to genetic changes in organisms and induction of cancer. While pharmaceutical companies and regulatory agencies have extensively used the standard battery, it is not suitable for compounds that may induce epigenetic changes...
2017: F1000Research
https://www.readbyqxmd.com/read/28168668/systems-biology-to-support-nanomaterial-grouping
#15
Christian Riebeling, Harald Jungnickel, Andreas Luch, Andrea Haase
The assessment of potential health risks of engineered nanomaterials (ENMs) is a challenging task due to the high number and great variety of already existing and newly emerging ENMs. Reliable grouping or categorization of ENMs with respect to hazards could help to facilitate prioritization and decision making for regulatory purposes. The development of grouping criteria, however, requires a broad and comprehensive data basis. A promising platform addressing this challenge is the systems biology approach. The different areas of systems biology, most prominently transcriptomics, proteomics and metabolomics, each of which provide a wealth of data that can be used to reveal novel biomarkers and biological pathways involved in the mode-of-action of ENMs...
2017: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/28168667/literature-review-of-q-sar-modelling-of-nanomaterial-toxicity
#16
Ceyda Oksel, Cai Y Ma, Jing J Liu, Terry Wilkins, Xue Z Wang
Despite the clear benefits that nanotechnology can bring to various sectors of industry, there are serious concerns about the potential health risks associated with engineered nanomaterials (ENMs), intensified by the limited understanding of what makes ENMs toxic and how to make them safe. As the use of ENMs for commercial purposes and the number of workers/end-users being exposed to these materials on a daily basis increases, the need for assessing the potential adverse effects of multifarious ENMs in a time- and cost-effective manner becomes more apparent...
2017: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/28137362/whole-genome-sequencing-of-mouse-lymphoma-l5178y-3-7-2c-tk-reveals-millions-of-mutations-and-genetic-markers
#17
Page B McKinzie, Javier R Revollo
The mouse lymphoma L5178Y-3.7.2C (TK(+/-)) cell line is extensively used in genetic toxicology to conduct the mouse lymphoma assay (MLA). The MLA is used to establish the mutagenic and clastogenic effects of chemicals and pharmaceuticals, and is one of the few genetic tests widely accepted by regulatory agencies throughout the world. Despite the extensive use and regulatory impact of L5178Y-3.7.2C (TK(+/-)) cells, little is known about their genetic composition or how it affects the outcome of the MLA. To determine the genetic background of this cell line, we sequenced and analyzed its entire genome...
February 2017: Mutation Research
https://www.readbyqxmd.com/read/28131796/alterations-in-microrna-expression-in-the-tissues-of-silver-carp-hypophthalmichthys-molitrix-following-microcystin-lr-exposure
#18
Yiyi Feng, Junguo Ma, Ruichen Xiang, Xiaoyu Li
In the field of toxicology, the relationship between microRNAs (miRNAs) and microcystin-LR (MC-LR) toxicity in fish is still poorly understood. In the present study, we used quantitative real-time PCR (qPCR) to examine the expression of 7 miRNAs (let-7b, miR-21, miR-122, miR-27b, miR-148, miR-125a, and miR-143) that play regulatory roles in biological processes such as signal transduction, apoptosis, cell cycle, and fatty acid metabolism. Expression patterns were assessed in the liver, spleen, and kidney of silver carp following 8, 24, and 48 h of exposure to MC-LR via intraperitoneal injection (50 or 200 μg/kg of body weight)...
January 25, 2017: Toxicon: Official Journal of the International Society on Toxinology
https://www.readbyqxmd.com/read/28127947/recommended-approaches-to-the-scientific-evaluation-of-ecotoxicological-hazards-and-risks-of-endocrine-active-substances
#19
Peter Matthiessen, Gerald T Ankley, Ronald C Biever, Poul Bjerregaard, Christopher Borgert, Kristin Brugger, Amy Blankinship, Janice Chambers, Katherine K Coady, Lisa Constantine, Zhichao Dang, Nancy D Denslow, David A Dreier, Steve Dungey, L Earl Gray, Melanie Gross, Patrick D Guiney, Markus Hecker, Henrik Holbech, Taisen Iguchi, Sarah Kadlec, Natalie K Karouna-Renier, Ioanna Katsiadaki, Yukio Kawashima, Werner Kloas, Henry Krueger, Anu Kumar, Laurent Lagadic, Annegaaike Leopold, Steven L Levine, Gerd Maack, Sue Marty, James Meador, Ellen Mihaich, Jenny Odum, Lisa Ortego, Joanne Parrott, Daniel Pickford, Mike Roberts, Christoph Schaefers, Tamar Schwarz, Keith Solomon, Tim Verslycke, Lennart Weltje, James R Wheeler, Mike Williams, Jeffrey C Wolf, Kunihiko Yamazaki
A SETAC Pellston Workshop(®) "Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Substances (EHRA)" was held in February 2016 in Pensacola, Florida, USA. The primary objective of the workshop was to provide advice, based on current scientific understanding, to regulators and policy makers; the aim being to make considered, informed decisions on whether to select an ecotoxicological hazard- or a risk-based approach for regulating a given endocrine-disrupting substance (EDS) under review...
March 2017: Integrated Environmental Assessment and Management
https://www.readbyqxmd.com/read/28127503/embryonic-zebrafish-model-a-well-established-method-for-rapidly-assessing-the-toxicity-of-homeopathic-drugs-toxicity-evaluation-of-homeopathic-drugs-using-zebrafish-embryo-model
#20
Himanshu R Gupta, Yogesh Patil, Dipty Singh, Mansee Thakur
OBJECTIVES: Advancements in nanotechnology have led to nanoparticle (NP) use in various fields of medicine. Although the potential of NPs is promising, the lack of documented evidence on the toxicological effects of NPs is concerning. A few studies have documented that homeopathy uses NPs. Unfortunately, very few sound scientific studies have explored the toxic effects of homeopathic drugs. Citing this lack of high-quality scientific evidence, regulatory agencies have been reluctant to endorse homeopathic treatment as an alternative or adjunct treatment...
December 2016: Journal of Pharmacopuncture
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