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Regulatory toxicology

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https://www.readbyqxmd.com/read/29330132/an-overview-of-the-safety-pharmacology-society-strategic-plan
#1
M K Pugsley, S Authier, J E Koerner, W S Redfern, C G Markgraf, T Brabham, K Correll, M V Soloviev, A Botchway, M Engwall, M Traebert, J-P Valentin, T J Mow, A Greiter-Wilke, D J Leishman, H M Vargas
Safety Pharmacology studies are conducted to characterize the confidence by which biologically active new chemical entities (NCE) may be anticipated as safe. Non-clinical safety pharmacology studies aim to detect and characterize potentially undesirable pharmacodynamic activities using an array of in silico, in vitro and in vivo animal models. While a broad spectrum of methodological innovation and advancement of the science occurs within the Safety Pharmacology Society, the society also focuses on partnerships with health authorities and technology providers and facilitates interaction with organizations of common interest such as pharmacology, physiology, neuroscience, cardiology and toxicology...
January 9, 2018: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/29324741/facilitating-healthcare-decisions-by-assessing-the-certainty-in-the-evidence-from-preclinical-animal-studies
#2
Carlijn R Hooijmans, Rob B M de Vries, Merel Ritskes-Hoitinga, Maroeska M Rovers, Mariska M Leeflang, Joanna IntHout, Kimberley E Wever, Lotty Hooft, Hans de Beer, Ton Kuijpers, Malcolm R Macleod, Emily S Sena, Gerben Ter Riet, Rebecca L Morgan, Kristina A Thayer, Andrew A Rooney, Gordon H Guyatt, Holger J Schünemann, Miranda W Langendam
Laboratory animal studies are used in a wide range of human health related research areas, such as basic biomedical research, drug research, experimental surgery and environmental health. The results of these studies can be used to inform decisions regarding clinical research in humans, for example the decision to proceed to clinical trials. If the research question relates to potential harms with no expectation of benefit (e.g., toxicology), studies in experimental animals may provide the only relevant or controlled data and directly inform clinical management decisions...
2018: PloS One
https://www.readbyqxmd.com/read/29321978/toxicity-of-formulants-and-heavy-metals-in-glyphosate-based-herbicides-and-other-pesticides
#3
N Defarge, J Spiroux de Vendômois, G E Séralini
The major pesticides of the world are glyphosate-based herbicides (GBH), and their toxicity is highly debated. To understand their mode of action, the comparative herbicidal and toxicological effects of glyphosate (G) alone and 14 of its formulations were studied in this work, as a model for pesticides. GBH are mixtures of water, with commonly 36-48% G claimed as the active principle. As with other pesticides, 10-20% of GBH consist of chemical formulants. We previously identified these by mass spectrometry and found them to be mainly families of petroleum-based oxidized molecules, such as POEA, and other contaminants...
2018: Toxicology Reports
https://www.readbyqxmd.com/read/29319937/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-reagents-for-molecular-diagnostic-instrument-test-systems-final-order
#4
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the reagents for molecular diagnostic instrument test systems into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
December 27, 2017: Federal Register
https://www.readbyqxmd.com/read/29301062/regulatory-roles-of-histone-deacetylases-1-and-2-in-pb-induced-neurotoxicity
#5
Yulan Wu, Yi Xu, Xiyao Huang, Danlei Ye, Miaomiao Han, Hui-Li Wang
Lead (Pb) prevails among the environmental hazards against human health. Although increasing evidence highlights the epigenetic roles underlying the Pb-induced neurotoxicity, the exact mechanisms concerning histone acetylation and its causative agents are still at its infancy. In the present study, the roles of histone deacetylases 1 and 2 (HDAC1/2), as well as histone H3 Lys9 acetylation (Ac-H3K9), in Pb-induced neurotoxicity were investigated. Pb was administered to PC12 cells at 10 μM for 24 hours. And Sprague- Dawley rats were chronically exposed to Pb through drinking water containing 250 ppm Pb for 2 months...
January 2, 2018: Toxicological Sciences: An Official Journal of the Society of Toxicology
https://www.readbyqxmd.com/read/29278994/regulatory-forum-opinion-piece-effective-brain-trimming-for-regulatory-type-nonclinical-toxicity-studies
#6
Brad Bolon
Regulatory guidances for nonclinical toxicity testing require brain evaluation but do not require a specific analytical strategy. The Society of Toxicologic Pathology (STP) has produced "best practice" recommendations for brain sampling and processing in general toxicity (GT) studies in adult rodents and nonrodents as well as developmental neurotoxicity (DNT) studies in rodents. This article explains acceptable brain trimming strategies as described in these 2 STP documents. Figures in the DNT and GT "best practices" illustrate coronal brain trimming at specific levels as defined by discrete external and internal anatomic landmarks...
January 1, 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/29273819/nanomaterials-certain-aspects-of-application-risk-assessment-and-risk-communication
#7
REVIEW
Peter Laux, Jutta Tentschert, Christian Riebeling, Albert Braeuning, Otto Creutzenberg, Astrid Epp, Valérie Fessard, Karl-Heinz Haas, Andrea Haase, Kerstin Hund-Rinke, Norbert Jakubowski, Peter Kearns, Alfonso Lampen, Hubert Rauscher, Reinhilde Schoonjans, Angela Störmer, Axel Thielmann, Uwe Mühle, Andreas Luch
Development and market introduction of new nanomaterials trigger the need for an adequate risk assessment of such products alongside suitable risk communication measures. Current application of classical and new nanomaterials is analyzed in context of regulatory requirements and standardization for chemicals, food and consumer products. The challenges of nanomaterial characterization as the main bottleneck of risk assessment and regulation are presented. In some areas, e.g., quantification of nanomaterials within complex matrices, the establishment and adaptation of analytical techniques such as laser ablation inductively coupled plasma mass spectrometry and others are potentially suited to meet the requirements...
December 22, 2017: Archives of Toxicology
https://www.readbyqxmd.com/read/29242156/an-avian-reproduction-study-historical-control-database-a-tool-for-data-interpretation
#8
Pablo Valverde-Garcia, Tim Springer, Vince Kramer, Manousos Foudoulakis, James R Wheeler
Avian reproduction studies are a regulatory requirement for pesticides in many regions. The data often require careful interpretation due to the nature of the study design. Here we present the historical control dataset for bobwhite quail and mallard duck reproduction studies performed at the Evans Analytical Group LLC avian toxicology laboratory over the period 1985-2016. The analysis demonstrates the stability of reproductive parameters over time and good agreement to normal control ranges as required by the regulatory test guidelines...
December 11, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/29242155/a-quantitative-comparison-of-points-of-departure-between-28-day-and-90-day-repeated-dose-studies-with-a-proposed-extrapolation-factor
#9
Bradley J Lampe, Emily Fuller, Senthilkumar P Kuppusamy
The influence of exposure duration on chemical toxicity has important implications for risk assessment. Although a default 10-fold extrapolation factor is commonly applied when the toxicological dataset includes a subchronic (90-day) study but lacks studies of chronic duration, little consensus has been reached on an appropriate extrapolation factor to apply when the dataset includes a 28-day study but lacks studies of longer durations. The goal of the present assessment was to identify a 28-day to 90-day extrapolation factor by analyzing distributions of ratios of No-Observed-Adverse-Effect Levels (NOAELs) and Benchmark Doses (BMDs) derived from 28-day and 90-day studies...
December 11, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/29203651/development-and-validation-of-a-high-throughput-transcriptomic-biomarker-to-address-21st-century-genetic-toxicology-needs
#10
Heng-Hong Li, Renxiang Chen, Daniel R Hyduke, Andrew Williams, Roland Frötschl, Heidrun Ellinger-Ziegelbauer, Raegan O'Lone, Carole L Yauk, Jiri Aubrecht, Albert J Fornace
Interpretation of positive genotoxicity findings using the current in vitro testing battery is a major challenge to industry and regulatory agencies. These tests, especially mammalian cell assays, have high sensitivity but suffer from low specificity, leading to high rates of irrelevant positive findings (i.e., positive results in vitro that are not relevant to human cancer hazard). We developed an in vitro transcriptomic biomarker-based approach that provides biological relevance to positive genotoxicity assay data, particularly for in vitro chromosome damage assays, and propose its application for assessing the relevance of the in vitro positive results to carcinogenic hazard...
December 4, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/29203341/in-vitro-to-in-vivo-extrapolation-for-high-throughput-prioritization-and-decision-making
#11
REVIEW
Shannon M Bell, Xiaoqing Chang, John F Wambaugh, David G Allen, Mike Bartels, Kim L R Brouwer, Warren M Casey, Neepa Choksi, Stephen S Ferguson, Grazyna Fraczkiewicz, Annie M Jarabek, Alice Ke, Annie Lumen, Scott G Lynn, Alicia Paini, Paul S Price, Caroline Ring, Ted W Simon, Nisha S Sipes, Catherine S Sprankle, Judy Strickland, John Troutman, Barbara A Wetmore, Nicole C Kleinstreuer
In vitro chemical safety testing methods offer the potential for efficient and economical tools to provide relevant assessments of human health risk. To realize this potential, methods are needed to relate in vitro effects to in vivo responses, i.e., in vitro to in vivo extrapolation (IVIVE). Currently available IVIVE approaches need to be refined before they can be utilized for regulatory decision-making. To explore the capabilities and limitations of IVIVE within this context, the U.S. Environmental Protection Agency Office of Research and Development and the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods co-organized a workshop and webinar series...
December 1, 2017: Toxicology in Vitro: An International Journal Published in Association with BIBRA
https://www.readbyqxmd.com/read/29191767/capsaicin-the-primary-constituent-of-pepper-sprays-and-its-pharmacological-effects-on-mammalian-ocular-tissues
#12
REVIEW
Harshita Krishnatreyya, Hemanga Hazarika, Achintya Saha, Pronobesh Chattopadhyay
Capsaicin is the principal constituent of Oleoresin capsicum, or Pepper spray, as it is commonly known. Pepper sprays are frequently used in riot control situations and have been used for many years to deal with uncontrolled civil demonstrations and disturbances by defence organizations all over the world. Although capsaicin is noted for its irritant and inflammatory properties but the ocular profile of capsaicin has not been specifically studied and interpreted. The present review analyses the mammalian opthalmological profile of capsaicin and its pharmacological and toxicological manifestations including capsaicin induced corneal changes, neurogenic inflammation, neuroprotective influences on Retinal ganglion cells (RGCs), depletion of neuropeptide content in sensory nerve terminals, etc...
November 27, 2017: European Journal of Pharmacology
https://www.readbyqxmd.com/read/29185060/the-comptox-chemistry-dashboard-a-community-data-resource-for-environmental-chemistry
#13
Antony J Williams, Christopher M Grulke, Jeff Edwards, Andrew D McEachran, Kamel Mansouri, Nancy C Baker, Grace Patlewicz, Imran Shah, John F Wambaugh, Richard S Judson, Ann M Richard
Despite an abundance of online databases providing access to chemical data, there is increasing demand for high-quality, structure-curated, open data to meet the various needs of the environmental sciences and computational toxicology communities. The U.S. Environmental Protection Agency's (EPA) web-based CompTox Chemistry Dashboard is addressing these needs by integrating diverse types of relevant domain data through a cheminformatics layer, built upon a database of curated substances linked to chemical structures...
November 28, 2017: Journal of Cheminformatics
https://www.readbyqxmd.com/read/29179566/the-safety%C3%A2-assessment-of-herbals-with-a-new-and-ethical-approach
#14
Eugenio Aiello, Roberto Russo, Claudia Cristiano, Antonio Calignano
The increasing use of plant medicines (herbals) in Europe needs a shared methodology to determine the toxicity and the daily exposure level to these drugs. For this reason, the European regulatory agencies have undertaken a study that could meet popular uses and toxicological research in different countries of the Union. Here we list some examples of the most used herbal drug classes and we propose a decision-making process based on their characteristics, their content in active principles and on the basis of the present scientific pharmacological and toxicological literature...
November 28, 2017: Natural Product Research
https://www.readbyqxmd.com/read/29161932/current-trends-in-in-silico-in-vitro-toxicology-and-safety-biomarkers-in-early-drug-development
#15
Simon Loiodice, Andre Nogueira da Costa, Franck Atienzar
The development of new medicines is a long and expensive process. Despite growing efforts in R&D over the last decades, attrition rate due to safety issues (especially cardiac and hepatic toxicity) remains a major challenge for the pharmaceutical industry. This may lead to market withdrawal or late stage halting of a drug development program. Consequently, early detection of toxicity issues is critical to avoid late-stage failures. To this end, development of predictive toxicology assays and models have become a strategic matter for drug makers...
November 21, 2017: Drug and Chemical Toxicology
https://www.readbyqxmd.com/read/29158043/six-years-after-the-nrc-review-of-epa-s-draft-iris-toxicological-review-of-formaldehyde-regulatory-implications-of-new-science-in-evaluating-formaldehyde-leukemogenicity
#16
Kenneth A Mundt, P Robinan Gentry, Linda D Dell, Joseph V Rodricks, Paolo Boffetta
Shortly after the International Agency for Research on Cancer (IARC) determined that formaldehyde causes leukemia, the United States Environmental Protection Agency (EPA) released its Draft IRIS Toxicological Review of Formaldehyde, also concluding that formaldehyde causes leukemia. Peer review of the EPA Draft IRIS Assessment by a National Academy of Science committee noted that "causal determinations are not supported by the narrative provided in the draft" {NRC 2011}. They offered recommendations for improving the IRIS review and identified several important research gaps...
November 17, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/29155963/generating-modelling-data-from-repeat-dose-toxicity-reports
#17
Oriol López-Massaguer, Kevin Pinto-Gil, Ferran Sanz, Alexander Amberg, Lennart T Anger, Manuela Stolte, Carlo Ravagli, Philippe Marc, Manuel Pastor
Over the past decades, pharmaceutical companies have conducted a large number of high quality in vivo repeat-dose toxicity (RDT) studies for regulatory purposes. As part of the eTOX project, a high number of these studies have been compiled and integrated into a database. This valuable resource can be queried directly, but it can be further exploited to build predictive models. As the studies were originally conducted to investigate the properties of individual compounds, the experimental conditions across the studies are highly heterogeneous...
November 16, 2017: Toxicological Sciences: An Official Journal of the Society of Toxicology
https://www.readbyqxmd.com/read/29155131/human-lung-epithelial-cell-cultures-for-analysis-of-inhaled-toxicants-lessons-learned-and-future-directions
#18
REVIEW
Pieter S Hiemstra, Gwendolynn Grootaers, Anne M van der Does, Cyrille A M Krul, Ingeborg M Kooter
The epithelium that covers the conducting airways and alveoli is a primary target for inhaled toxic substances, and therefore a focus in inhalation toxicology. The increasing concern about the use of animal models has stimulated the development of in vitro cell culture models for analysis of the biological effects of inhaled toxicants. However, the validity of the current in vitro models and their acceptance by regulatory authorities as an alternative to animal models is a reason for concern, and requires a critical review...
November 15, 2017: Toxicology in Vitro: An International Journal Published in Association with BIBRA
https://www.readbyqxmd.com/read/29151874/incorporating-evolutionary-insights-to-improve-ecotoxicology-for-freshwater-species
#19
Steven P Brady, Jonathan L Richardson, Bethany K Kunz
Ecotoxicological studies have provided extensive insights into the lethal and sublethal effects of environmental contaminants. These insights are critical for environmental regulatory frameworks, which rely on knowledge of toxicity for developing policies to manage contaminants. While varied approaches have been applied to ecotoxicological questions, perspectives related to the evolutionary history of focal species or populations have received little consideration. Here, we evaluate chloride toxicity from the perspectives of both macroevolution and contemporary evolution...
September 2017: Evolutionary Applications
https://www.readbyqxmd.com/read/29150682/enantioselective-transformation-of-fluoxetine-in-water-and-its-ecotoxicological-relevance
#20
María Jesús Andrés-Costa, Kathryn Proctor, Marco T Sabatini, Anthony P Gee, Simon E Lewis, Yolanda Pico, Barbara Kasprzyk-Hordern
European legislation focusing on water quality is expected to broaden to encompass several pharmaceuticals as priority hazardous substances. This manuscript aims to challenge current regulatory approaches that do not recognize stereochemistry of chiral pharmaceuticals by testing the hypothesis that environmental transformation and effects of chiral pharmaceuticals are stereoselective. Our experiments revealed that, while degradation of chiral fluoxetine (FL) in river water occurs via non-enantioselective photochemical and mildly-enantioselective microbial processes favoring the (R)-enantiomer, a pronounced enantioselectivity favoring (S)-FL (leading to the formation of (S)-NFL (norfluoxetine)) is observed during activated sludge treatment...
November 17, 2017: Scientific Reports
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