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Regulatory toxicology

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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
#1
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
#2
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
#3
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
#4
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...
February 10, 2017: Toxicology Letters
https://www.readbyqxmd.com/read/28189099/miniaturising-acute-toxicity-and-feeding-rate-measurements-in-daphnia-magna
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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...
January 27, 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
#12
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
https://www.readbyqxmd.com/read/28122673/mechanisms-of-nickel-toxicity-to-fish-and-invertebrates-in-marine-and-estuarine-waters
#13
REVIEW
Tamzin A Blewett, Erin M Leonard
In freshwater settings the toxicity of the trace metal nickel (Ni) is relatively well understood. However, until recently, there was little knowledge regarding Ni toxicity in waters of higher salinity, where factors such as water chemistry and the physiology of estuarine and marine biota would be expected to alter toxicological impact. This review summarizes recent literature investigating Ni toxicity in marine and estuarine invertebrates and fish. As in freshwater, three main mechanisms of Ni toxicity exist: ionoregulatory impairment, inhibition of respiration, and promotion of oxidative stress...
January 22, 2017: Environmental Pollution
https://www.readbyqxmd.com/read/28111422/humidifier-disinfectant-disaster-what-do-we-know-and-what-are-left-to-be-clarified
#14
Sungkyoon Kim, Domyung Paek
After the initial investigations of Korean CDC in 2011, more than 1,000 suspicious cases of humidifier disinfectant victims were subsequently reported up to 2015, and numbers are still increasing dramatically in 2016 in the midst of prosecutor's office investigation. In this study, we tried to summarize the current understandings of humidifier disinfectant related health effects based upon systemic review of published epidemiologic studies and toxicology investigations. Published studies of humidifier disinfectants were searched through 'pubmed' and 'toxline'?under the heading of 'humidifier disinfectant', and related reports were identified from the references and published report list of regulatory agencies including Korean National Institute of Environmental Research, US Environmental Protection Agency, and EU European Chemicals Agency...
December 4, 2016: Environmental Health and Toxicology
https://www.readbyqxmd.com/read/28109771/assessment-of-learning-memory-and-attention-in-developmental-neurotoxicology-regulatory-testing-commentary-on-essentiality-of-cognitive-assessment-for-protecting-child-health
#15
Charles V Vorhees
This commentary is in response to the remarks of Drs. Christina Sobin, Mari Golub, and David Herr on the Special Issue of this Journal entitled "Assessment of Learning, Memory, and Attention in Developmental Neurotoxicology Regulatory Testing." I endorse the views expressed by Drs. Sobin, Golub, and Herr and add some discussion on a recent Organization on Economic Cooperation and Development (OECD) guideline, the Extended One Generation Reproductive Toxicology Guideline (OECD 446), in which testing for higher cognitive function (learning and memory) has been eliminated...
January 18, 2017: Neurotoxicology and Teratology
https://www.readbyqxmd.com/read/28092200/the-challenges-surrounding-preclinical-testing-in-transcatheter-device-development-and-the-implications-on-the-clinic
#16
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 31, 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
#17
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...
March 1, 2017: Science of the Total Environment
https://www.readbyqxmd.com/read/28062373/liposomal-encapsulation-masks-genotoxicity-of-a-chemotherapeutic-agent-in-regulatory-toxicology-assessments
#18
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
#19
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...
February 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28054977/forthcoming-challenges-in-mycotoxins-toxicology-research-for-safer-food-a-need-for-multi-omics-approach
#20
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
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