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Regulatory toxicology

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https://www.readbyqxmd.com/read/28092200/the-challenges-surrounding-preclinical-testing-in-transcatheter-device-development-and-the-implications-on-the-clinic
#1
Ralf Holzer, Jake Goble, Ziyad Hijazi
Transcatheter devices have contributed significantly to the advances achieved in treating many cardiovascular conditions over the last few decades. Sophisticated and detailed preclinical testing is not only a regulatory requirement to support an investigational device exemption (IDE) application, but more crucially its success and accuracy is needed to safeguard patients during the subsequent clinical testing stages. Areas Covered: This article covers the regulatory background as well as specific considerations related to pre-clinical testing of transcatheter devices...
January 16, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28065543/mitigating-dietary-arsenic-exposure-current-status-in-the-united-states-and-recommendations-for-an-improved-path-forward
#2
Keeve E Nachman, Gary L Ginsberg, Mark D Miller, Carolyn J Murray, Anne E Nigra, Claire B Pendergrast
Inorganic arsenic (iAs) is a well-characterized carcinogen, and recent epidemiologic studies have linked chronic exposures to non-cancer health outcomes, including cardiovascular disease, diabetes, skin lesions and respiratory disorders. Greater vulnerability has been demonstrated with early life exposure for health effects including lung and bladder cancer, immunotoxicity and neurodevelopment. Despite its well-known toxicity, there are important gaps in the regulatory oversight of iAs in food and in risk communication...
January 5, 2017: Science of the Total Environment
https://www.readbyqxmd.com/read/28062373/liposomal-encapsulation-masks-genotoxicity-of-a-chemotherapeutic-agent-in-regulatory-toxicology-assessments
#3
Jenolyn F Alexander, David Aguirre-Villarreal, Biana Godin
The burgeoning application of nanotechnology to a variety of industries including cosmetics, food, medicine and materials has led to the exploration of nanotoxicology as a trending subject of research. However the role of a nanovector, in affecting the mutagenicity of its therapeutic payload has not yet been investigated. In this study, we compare the mutagenicity of the free drug - doxorubicin hydrochloride with its nanoencapsulated form - doxorubicin loaded liposome, using conventional methods required for regulatory approval...
January 3, 2017: Nanomedicine: Nanotechnology, Biology, and Medicine
https://www.readbyqxmd.com/read/28056663/principles-for-assessing-adversity-in-toxicologic-clinical-pathology
#4
Lila Ramaiah, Lindsay Tomlinson, Niraj K Tripathi, Laura C Cregar, Allison Vitsky, Barbara von Beust, Valerie G Barlow, William J Reagan, Daniela Ennulat
There is limited direction in the literature or regulatory guidance on determination of adversity for clinical pathology (CP) biomarkers in preclinical safety studies. Toxicologic clinical pathologists representing the American Society for Veterinary Clinical Pathology-Regulatory Affairs Committee and Society of Toxicologic Pathology-Clinical Pathology Interest Group identified principles, overall approach, and unique considerations for assessing adversity in CP data interpretation to provide a consensus opinion...
January 1, 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28054977/forthcoming-challenges-in-mycotoxins-toxicology-research-for-safer-food-a-need-for-multi-omics-approach
#5
REVIEW
Luca Dellafiora, Chiara Dall'Asta
The presence of mycotoxins in food represents a severe threat for public health and welfare, and poses relevant research challenges in the food toxicology field. Nowadays, food toxicologists have to provide answers to food-related toxicological issues, but at the same time they should provide the appropriate knowledge in background to effectively support the evidence-based decision-making in food safety. Therefore, keeping in mind that regulatory actions should be based on sound scientific findings, the present opinion addresses the main challenges in providing reliable data for supporting the risk assessment of foodborne mycotoxins...
January 4, 2017: Toxins
https://www.readbyqxmd.com/read/28053074/promoting-adoption-of-the-3rs-through-regulatory-qualification
#6
Elizabeth Gribble Walker, Amanda F Baker, John-Michael Sauer
One mechanism to advance the application of novel safety assessment methodologies in drug development, including in silico or in vitro approaches that reduce the use of animals in toxicology studies, is regulatory qualification. Regulatory qualification, a formal process defined at the the U. S. Food and Drug Administration and the European Medicines Agency, hinges on a central concept of stating an appropriate "context of use" for a novel drug development tool (DDT) that precisely defines how that DDT can be used to support decision making in a regulated drug development setting...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053064/scientific-knowledge-and-technology-animal-experimentation-and-pharmaceutical-development
#7
Lewis B Kinter, Joseph J DeGeorge
Human discovery of pharmacologically active substances is arguably the oldest of the biomedical sciences with origins >3500 years ago. Since ancient times, four major transformations have dramatically impacted pharmaceutical development, each driven by advances in scientific knowledge, technology, and/or regulation: (1) anesthesia, analgesia, and antisepsis; (2) medicinal chemistry; (3) regulatory toxicology; and (4) targeted drug discovery. Animal experimentation in pharmaceutical development is a modern phenomenon dating from the 20th century and enabling several of the four transformations...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28040195/human-health-screening-and-public-health-significance-of-contaminants-of-emerging-concern-detected-in-public-water-supplies
#8
Robert Benson, Octavia D Conerly, William Sander, Angela L Batt, J Scott Boone, Edward T Furlong, Susan T Glassmeyer, Dana W Kolpin, Heath E Mash, Kathleen M Schenck, Jane Ellen Simmons
The source water and treated drinking water from twenty five drinking water treatment plants (DWTPs) across the United States were sampled in 2010-2012. Samples were analyzed for 247 contaminants using 15 chemical and microbiological methods. Most of these contaminants are not regulated currently either in drinking water or in discharges to ambient water by the U. S. Environmental Protection Agency (USEPA) or other U.S. regulatory agencies. This analysis shows that there is little public health concern for most of the contaminants detected in treated water from the 25 DWTPs participating in this study...
February 1, 2017: Science of the Total Environment
https://www.readbyqxmd.com/read/28032149/dtni-a-novel-toxicogenomics-data-analysis-tool-for-identifying-the-molecular-mechanisms-underlying-the-adverse-effects-of-toxic-compounds
#9
Diana M Hendrickx, Terezinha Souza, Danyel G J Jennen, Jos C S Kleinjans
Unravelling gene regulatory networks (GRNs) influenced by chemicals is a major challenge in systems toxicology. Because toxicant-induced GRNs evolve over time and dose, the analysis of global gene expression data measured at multiple time points and doses will provide insight in the adverse effects of compounds. Therefore, there is a need for mathematical methods for GRN identification from time-over-dose-dependent data. One of the current approaches for GRN inference is Time Series Network Identification (TSNI)...
December 28, 2016: Archives of Toxicology
https://www.readbyqxmd.com/read/28031415/evaluation-of-batch-variations-in-induced-pluripotent-stem-cell-derived-human-cardiomyocytes-from-2-major-suppliers
#10
Jianhua Huo, Archana Kamalakar, Xi Yang, Beverly Word, Norman Stockbridge, Beverly Lyn-Cook, Li Pang
Drug-induced proarrhythmia is a major safety issue in drug development. Developing sensitive in vitro assays that can predict drug-induced cardiotoxicity in humans has been a challenge of toxicology research for decades. Recently, induced pluripotent stem cell-derived human cardiomyocytes (iPSC-hCMs) have become a promising model because they largely replicate the electrophysiological behavior of human ventricular cardiomyocytes. Patient-specific iPSC-hCMs have been proposed for personalized cardiac drug selection and adverse drug response prediction; however, many procedures are involved in cardiomyocytes differentiation and purification process, which may result in large line-to-line and batch-to-batch variations...
December 28, 2016: Toxicological Sciences: An Official Journal of the Society of Toxicology
https://www.readbyqxmd.com/read/28024743/human-exposure-to-organic-arsenic-species-from-seafood
#11
Vivien Taylor, Britton Goodale, Andrea Raab, Tanja Schwerdtle, Ken Reimer, Sean Conklin, Margaret R Karagas, Kevin A Francesconi
Seafood, including finfish, shellfish, and seaweed, is the largest contributor to arsenic (As) exposure in many human populations. In contrast to the predominance of inorganic As in water and many terrestrial foods, As in marine-derived foods is present primarily in the form of organic compounds. To date, human exposure and toxicological assessments have focused on inorganic As, while organic As has generally been considered to be non-toxic. However, the high concentrations of organic As in seafood, as well as the often complex As speciation, can lead to complications in assessing As exposure from diet...
December 23, 2016: Science of the Total Environment
https://www.readbyqxmd.com/read/27994170/how-adverse-outcome-pathways-can-aid-the-development-and-use-of-computational-prediction-models-for-regulatory-toxicology
#12
REVIEW
Clemens Wittwehr, Hristo Aladjov, Gerald Ankley, Hugh J Byrne, Joop de Knecht, Elmar Heinzle, Günter Klambauer, Brigitte Landesmann, Mirjam Luijten, Cameron MacKay, Gavin Maxwell, M E Bette Meek, Alicia Paini, Edward Perkins, Tomasz Sobanski, Dan Villeneuve, Katrina M Waters, Maurice Whelan
Efforts are underway to transform regulatory toxicology and chemical safety assessment from a largely empirical science based on direct observation of apical toxicity outcomes in whole organism toxicity tests to a predictive one in which outcomes and risk are inferred from accumulated mechanistic understanding. The adverse outcome pathway (AOP) framework provides a systematic approach for organizing knowledge that may support such inference. Likewise, computational models of biological systems at various scales provide another means and platform to integrate current biological understanding to facilitate inference and extrapolation...
December 19, 2016: Toxicological Sciences: An Official Journal of the Society of Toxicology
https://www.readbyqxmd.com/read/27979774/gene-regulatory-networks-in-differentiation-and-direct-reprogramming-of-hepatic-cells
#13
REVIEW
Claude Gérard, Janne Tys, Frédéric P Lemaigre
Liver development proceeds by sequential steps during which gene regulatory networks (GRNs) determine differentiation and maturation of hepatic cells. Characterizing the architecture and dynamics of these networks is essential for understanding how cell fate decisions are made during development, and for recapitulating these processes during in vitro production of liver cells for toxicology studies, disease modelling and regenerative therapy. Here we review the GRNs that control key steps of liver development and lead to differentiation of hepatocytes and cholangiocytes in mammals...
December 12, 2016: Seminars in Cell & Developmental Biology
https://www.readbyqxmd.com/read/27976826/challenges-in-assigning-endocrine-specific-modes-of-action-recommendations-for-researchers-and-regulators
#14
Ellen M Mihaich, Christoph Schäfers, David A Dreier, Markus Hecker, Lisa Ortego, Yukio Kawashima, Zhi-Chao Dang, Keith Solomon
As regulatory programs evaluate substances for their endocrine disrupting properties, careful study design and data interpretation is needed to distinguish between responses that are truly endocrine-specific and those that are not. This is particularly important in regulatory environments where criteria are under development to identify endocrine disrupting properties to enable hazard-based regulation. Irrespective of these processes, most jurisdictions use the WHO/IPCS definition of an endocrine disruptor (ED), requiring that a substance is demonstrated to cause a change in endocrine function that consequently leads to an adverse effect in an intact organism...
December 15, 2016: Integrated Environmental Assessment and Management
https://www.readbyqxmd.com/read/27936962/using-high-content-screening-technology-for-studying-drug-induced-hepatotoxicity-in-preclinical-studies
#15
Maria Teresa Donato, Maria José Gómez-Lechón, Laia Tolosa
The need for alternatives to animal experimentation and traditional testing methods has been widely discussed in recent years. This has led scientists and regulatory authorities to investigate alternative methods for toxicity testing. High-content screening (HCS) has emerged as a powerful tool in predictive toxicology since it permits molecular, cellular and tissue-based toxicity assessments. HCS allows automated image acquisition and analysis, and provides information on multiple properties of individual cells loaded simultaneously with fluorescent dyes, which is used for drug safety evaluations...
December 21, 2016: Expert Opinion on Drug Discovery
https://www.readbyqxmd.com/read/27934287/mutagenic-azo-dyes-rather-than-flame-retardants-are-the-predominant-brominated-compounds-in-house-dust
#16
Hui Peng, David M V Saunders, Jianxian Sun, Paul D Jones, Chris K C Wong, Hongling Liu, John P Giesy
Characterization of toxicological profiles by use of traditional targeted strategies might underestimate the risk of environmental mixtures. Unbiased identification of prioritized compounds provides a promising strategy for meeting regulatory needs. In this study, untargeted screening of brominated compounds in house dust was conducted using a data-independent precursor isolation and characteristic fragment (DIPIC-Frag) approach, which used data-independent acquisition (DIA) and a chemometric strategy to detect peaks and align precursor ions...
December 6, 2016: Environmental Science & Technology
https://www.readbyqxmd.com/read/27917502/relationship-between-increasing-concentrations-of-two-carcinogens-and-statistical-image-descriptors-of-foci-morphology-in-the-cell-transformation-assay
#17
Giulia Callegaro, Raffaella Corvi, Susan Salovaara, Chiara Urani, Federico M Stefanini
Cell Transformation Assays (CTAs) have long been proposed for the identification of chemical carcinogenicity potential. The endpoint of these in vitro assays is represented by the phenotypic alterations in cultured cells, which are characterized by the change from the non-transformed to the transformed phenotype. Despite the wide fields of application and the numerous advantages of CTAs, their use in regulatory toxicology has been limited in part due to concerns about the subjective nature of visual scoring, i...
December 5, 2016: Journal of Applied Toxicology: JAT
https://www.readbyqxmd.com/read/27912163/reproduction-impairment-and-endocrine-disruption-in-adult-zebrafish-danio-rerio-after-waterborne-exposure-to-tboep
#18
Qinglong Xu, Ding Wu, Yao Dang, Liqin Yu, Chunsheng Liu, Jianghua Wang
Tris (2-butoxyethyl) phosphate (TBOEP) is widely used as a substitute of polybrominated diphenyl ethers (PBDEs). It has been frequently measured at concentrations of micrograms per liter (μg/L) in surface waters and waste water. However, limited information is available about the reproduction toxicology of TBOEP. In this study, adult zebrafish pairs were exposed to TBOEP at concentrations of 0, 5, 50, and 500μg/L for 21days. The effects on reproduction, hormone concentration, transcription of genes along the hypothalamic-pituitary-gonadal (HPG) axis, and gonadal development were investigated...
January 2017: Aquatic Toxicology
https://www.readbyqxmd.com/read/27905399/cellular-reactions-to-long-term-volatile-organic-compound-voc-exposures
#19
Johanna M Gostner, Johannes Zeisler, Mohammad Tauqeer Alam, Peter Gruber, Dietmar Fuchs, Kathrin Becker, Kerstin Neubert, Markus Kleinhappl, Stefan Martini, Florian Überall
Investigations of cellular processes initiated by volatile organic compounds (VOCs) are limited when modelling realistic long-term exposure scenarios at low concentrations. Exposure to indoor VOCs is associated with a range of adverse effects, but data on molecular changes at regulatory threshold limits are lacking. Activity analysis of VOC in vitro can be a valuable complement to inhalation toxicological evaluations. We developed an exposure platform that generates a stable VOC atmosphere and allows the exposure of cells for longer periods...
December 1, 2016: Scientific Reports
https://www.readbyqxmd.com/read/27886581/a-multi-omic-approach-to-elucidate-low-dose-effects-of-xenobiotics-in-zebrafish-danio-rerio-larvae
#20
Susie S Y Huang, Jonathan P Benskin, Nik Veldhoen, Bharat Chandramouli, Heather Butler, Caren C Helbing, John R Cosgrove
Regulatory-approved toxicity assays such as the OECD Fish Embryo Toxicity Assay (TG236) allow correlation of chemical exposure to adverse morphological phenotypes. However, these assays are ineffective in assessing sub-lethal (i.e. low-dose) effects, or differentiating between similar phenotypes induced by different chemicals. Inclusion of multi-omic analyses in studies investigating xenobiotic action provides improved characterization of biological response, thereby enhancing prediction of toxicological outcomes in whole animals in the absence of morphological effects...
January 2017: Aquatic Toxicology
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