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Regulatory toxicology

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https://www.readbyqxmd.com/read/28440957/the-role-of-high-throughput-screening-in-ecotoxicology-and-engineered-nanomaterials
#1
REVIEW
Andrew Barrick, Amélie Châtel, Mélanie Bruneau, Catherine Mouneyrac
The field of environmental toxicology developed as a result of growing concerns about anthropogenic influences on the environment and how to ameliorate ecological impact. Many governmental bodies are beginning to emphasize prevention rather than mitigation when addressing novel products, leading to more of a focus on identifying potential toxicity prior to release. With the exponential advances in their development and sale, novel metamaterials and biotechnology are set to dramatically outpace the capabilities of current testing strategies...
April 25, 2017: Environmental Toxicology and Chemistry
https://www.readbyqxmd.com/read/28433707/genetic-susceptibility-to-toxicologic-lung-responses-among-inbred-mouse-strains-following-exposure-to-carbon-nanotubes-and-profiling-of-underlying-gene-networks
#2
Evan A Frank, Vinicius S Carreira, Kumar Shanmukhappa, Mario Medvedovic, Daniel R Prows, Jagjit S Yadav
The risk of human exposure to fiber nanoparticles has risen in recent years due to increases in the manufacture and utilization of carbon nanotubes (CNTs). CNTs are present as airborne particulates in occupational settings and their hazard potential has been demonstrated in experimental lung exposure studies using inbred mouse strains. However, it is not known whether different inbred strains differ in lung responses to CNTs by virtue of their genetics. In this work, common inbred strains (BALB/c, C57Bl/6, DBA/2, and C3H/He) were exposed to CNTs via oropharyngeal aspiration and lung histology and bronchoalveolar lavage (BAL) samples were evaluated over 28days with the objective of evaluating sensitivity/resistance among strains...
April 19, 2017: Toxicology and Applied Pharmacology
https://www.readbyqxmd.com/read/28433587/pharmacokinetic-and-toxicology-comparator-testing-of-biosimilar-drugs-assessing-need
#3
Paul Baldrick
A key element in the development of a biosimilar molecule is the comparability of the biological activity/nonclinical similarity to the innovator drug. Although some regulatory guidelines are encouraging little or no in vivo testing, currently a common practice is to perform at least one toxicology and/or one pharmacokinetic (PK) study to assess if any different findings occur for in-life, clinical pathology and histopathological parameters or in exposure. An exercise was performed in which the results of such testing were evaluated...
April 20, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28430618/t-2-mycotoxin-toxicological-effects-and-decontamination-strategies
#4
REVIEW
Manish Adhikari, Bhawana Negi, Neha Kaushik, Anupriya Adhikari, Abdulaziz A Al-Khedhairy, Nagendra Kumar Kaushik, Eun Ha Choi
Mycotoxins are highly diverse secondary metabolites produced in nature by a wide variety of fungus which causes food contamination, resulting in mycotoxicosis in animals and humans. In particular, trichothecenes mycotoxin produced by genus fusarium is agriculturally more important worldwide due to the potential health hazards they pose. It is mainly metabolized and eliminated after ingestion, yielding more than 20 metabolites with the hydroxy trichothecenes-2 toxin being the major metabolite. Trichothecene is hazardously intoxicating due to their additional potential to be topically absorbed, and their metabolites affect the gastrointestinal tract, skin, kidney, liver, and immune and hematopoietic progenitor cellular systems...
February 16, 2017: Oncotarget
https://www.readbyqxmd.com/read/28403478/non-animal-approaches-for-toxicokinetics-in-risk-evaluations-of-food-chemicals
#5
Ans Punt, Ad A C M Peijnenburg, Ron L A P Hoogenboom, Hans Bouwmeester
The objective of the present work was to review the availability and predictive value of non-animal toxicokinetic approaches and to evaluate their current use in European risk evaluations of food contaminants, additives and food contact materials, as well as pesticides and medicines. Results revealed little use of quantitative animal or human kinetic data in risk evaluations of food chemicals, compared with pesticides and medicines. Risk evaluations of medicines provided sufficient in vivo kinetic data from different species to evaluate the predictive value of animal kinetic data for humans...
April 12, 2017: ALTEX
https://www.readbyqxmd.com/read/28393481/comparative-study-of-therapeutic-antibody-candidates-derived-from-mini-pool-and-clonal-cell-lines
#6
Lianchun Fan, Giovanni Rizzi, Kathleen Bierilo, Jun Tian, Joon Chong Yee, Reb Russel, Tapan Das
The long journey of developing a drug from initial discovery target identification to regulatory approval often leaves many patients with missed window of opportunities. Both regulatory agencies and biopharmaceutical industry continue to develop creative approaches to shorten the time of new drug development in order to deliver life-saving medicine to patients. Historically, drug substance materials to support the toxicology and early phase clinical study can only be manufactured after creating the final Master Cell Bank (MCB) of the clonally-derived cell line, which normally takes 1-2 years...
April 10, 2017: Biotechnology Progress
https://www.readbyqxmd.com/read/28391123/aminomethylphosphonic-acid-ampa-in-natural-waters-its-sources-behavior-and-environmental-fate
#7
REVIEW
Alexis Grandcoin, Stéphanie Piel, Estelle Baurès
The widely occurring degradation product aminomethylphosphonic acid (AMPA) is a result of glyphosate and amino-polyphosphonate degradation. Massive use of the parent compounds leads to the ubiquity of AMPA in the environment, and particularly in water. The purpose of this review is to summarize and discuss current insights into AMPA formation, transport, persistence and toxicity. In agricultural soils, AMPA is concentrated in the topsoil, and degrades slowly in most soils. It can reach shallow groundwater, but rarely managed to enter deep groundwater...
March 27, 2017: Water Research
https://www.readbyqxmd.com/read/28388695/regulation-of-drug-metabolism-and-toxicity-by-multiple-factors-of-genetics-epigenetics-lncrnas-gut-microbiota-and-diseases-a-meeting-report-of-the-21-st-international-symposium-on-microsomes-and-drug-oxidations-mdo
#8
Ai-Ming Yu, Magnus Ingelman-Sundberg, Nathan J Cherrington, Lauren M Aleksunes, Ulrich M Zanger, Wen Xie, Hyunyoung Jeong, Edward M Morgan, Peter J Turnbaugh, Curtis D Klaassen, Aadra P Bhatt, Matthew R Redinbo, Pengying Hao, David J Waxman, Li Wang, Xiao-Bo Zhong
Variations in drug metabolism may alter drug efficacy and cause toxicity; better understanding of the mechanisms and risks shall help to practice precision medicine. At the 21(st) International Symposium on Microsomes and Drug Oxidations held in Davis, California, USA, in October 2-6, 2016, a number of speakers reported some new findings and ongoing studies on the regulation mechanisms behind variable drug metabolism and toxicity, and discussed potential implications to personalized medications. A considerably insightful overview was provided on genetic and epigenetic regulation of gene expression involved in drug absorption, distribution, metabolism, and excretion (ADME) and drug response...
March 2017: Acta Pharmaceutica Sinica. B
https://www.readbyqxmd.com/read/28381719/practice-of-regulatory-science-drug-development
#9
Toru Kawanishi
 The practice of regulatory science (RS) for drug development is described. In the course material for education in pharmaceutical sciences drafted by the RS Division of the Pharmaceutical Society of Japan, RS for pharmaceuticals is defined as the science of predicting, assessing, and judging the quality, efficacy, and safety of pharmaceutical products throughout their lifespan. RS is also described as an integrated science based on basic and applied biomedical sciences, including analytical chemistry, biochemistry, pharmacology, toxicology, genetics, biostatistics, epidemiology, and clinical trial methodology, and social sciences such as decision science, risk assessment, and communication science...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28374158/glyphosate-toxicity-and-carcinogenicity-a-review-of-the-scientific-basis-of-the-european-union-assessment-and-its-differences-with-iarc
#10
REVIEW
Jose V Tarazona, Daniele Court-Marques, Manuela Tiramani, Hermine Reich, Rudolf Pfeil, Frederique Istace, Federica Crivellente
Glyphosate is the most widely used herbicide worldwide. It is a broad spectrum herbicide and its agricultural uses increased considerably after the development of glyphosate-resistant genetically modified (GM) varieties. Since glyphosate was introduced in 1974, all regulatory assessments have established that glyphosate has low hazard potential to mammals, however, the International Agency for Research on Cancer (IARC) concluded in March 2015 that it is probably carcinogenic. The IARC conclusion was not confirmed by the EU assessment or the recent joint WHO/FAO evaluation, both using additional evidence...
April 3, 2017: Archives of Toxicology
https://www.readbyqxmd.com/read/28359992/bioassays-for-toxicological-risk-assessment-of-landfill-leachate-a-review
#11
REVIEW
Pooja Ghosh, Indu Shekhar Thakur, Anubha Kaushik
Landfilling is the most common solid waste management practice. However, there exist a potential environmental risk to the surface and ground waters due to the possible leaching of contaminants from the landfill leachates. Current municipal solid waste landfill regulatory approaches consider physicochemical characterization of the leachate and do not assess their potential toxicity. However, assessment of toxic effects of the leachates using rapid, sensitive and cost-effective biological assays is more useful in assessing the risks as they measure the overall toxicity of the chemicals in the leachate...
March 27, 2017: Ecotoxicology and Environmental Safety
https://www.readbyqxmd.com/read/28355063/quantitative-adverse-outcome-pathways-and-their-application-to-predictive-toxicology
#12
Rory B Conolly, Gerald T Ankley, WanYun Cheng, Michael L Mayo, David H Miller, Edward J Perkins, Daniel L Villeneuve, Karen H Watanabe
A quantitative adverse outcome pathway (qAOP) consists of one or more biologically based, computational models describing key event relationships linking a molecular initiating event (MIE) to an adverse outcome. A qAOP provides quantitative, dose-response, and time-course predictions that can support regulatory decision-making. Herein we describe several facets of qAOPs, including (a) motivation for development, (b) technical considerations, (c) evaluation of confidence, and (d) potential applications. The qAOP used as an illustrative example for these points describes the linkage between inhibition of cytochrome P450 19A aromatase (the MIE) and population-level decreases in the fathead minnow (FHM; Pimephales promelas)...
April 7, 2017: Environmental Science & Technology
https://www.readbyqxmd.com/read/28351296/regulatory-forum-opinion-piece
#13
Sherry J Morgan, Jessica Couch, Peggy Guzzie-Peck, Douglas A Keller, Ray Kemper, Monicah A Otieno, Robert J Schulingkamp, Thomas W Jones
An Innovation and Quality (IQ) Consortium focus group conducted a cross-company survey to evaluate current practices and perceptions around the use of animal models of disease (AMDs) in nonclinical safety assessment of molecules in clinical development. The IQ Consortium group is an organization of pharmaceutical and biotechnology companies with the mission of advancing science and technology. The survey queried the utilization of AMDs during drug discovery in which drug candidates are evaluated in efficacy models and limited short-duration non-Good Laboratory Practices (GLP) toxicology testing and during drug development in which drug candidates are evaluated in GLP toxicology studies...
January 1, 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28350814/compensatory-changes-in-cyp-expression-in-three-different-toxicology-mouse-models-car-null-cyp3a-null-and-cyp2b9-10-13-null-mice
#14
Ramiya Kumar, Linda C Mota, Elizabeth J Litoff, John P Rooney, W Tyler Boswell, Elliott Courter, Charles M Henderson, Juan P Hernandez, J Christopher Corton, David D Moore, William S Baldwin
Targeted mutant models are common in mechanistic toxicology experiments investigating the absorption, metabolism, distribution, or elimination (ADME) of chemicals from individuals. Key models include those for xenosensing transcription factors and cytochrome P450s (CYP). Here we investigated changes in transcript levels, protein expression, and steroid hydroxylation of several xenobiotic detoxifying CYPs in constitutive androstane receptor (CAR)-null and two CYP-null mouse models that have subfamily members regulated by CAR; the Cyp3a-null and a newly described Cyp2b9/10/13-null mouse model...
2017: PloS One
https://www.readbyqxmd.com/read/28349785/inflammatory-cell-findings-in-the-female-rabbit-heart-and-stress-associated-exacerbation-with-handling-and-procedures-used-in-nonclinical-studies
#15
Rani S Sellers, Ingrid Pardo, George Hu, K Nasir Khan, Richard Perry, Victoria Markiewicz, Cynthia Rohde, Jennifer Colangelo, William Reagan, David Clarke
Despite the use of rabbits in biomedical research, including regulatory toxicology and cardiovascular studies, little data exist on heart findings in this species. This study was designed to document myocardial findings in female rabbits and the impact of study-related procedures typical for vaccine toxicology studies. One hundred and forty 6- to 8-month-old female New Zealand White rabbits were divided equally into 2 groups, high and low study procedure groups (group 1 and group 2, respectively). All animals received intramuscular (IM) injections of sterile saline every 2 weeks for 5 times and were necropsied 2 days after the final IM injection...
January 1, 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28339012/heavy-metal-content-and-molecular-species-identification-in-canned-tuna-insights-into-human-food-safety
#16
Anna Maria Pappalardo, Chiara Copat, Venera Ferrito, Alfina Grasso, Margherita Ferrante
Canned tuna in olive oil and in brine of the most popular brands sold in Italian markets were analyzed to verify the authentication of transformed products, with the aim to unveil commercial frauds due to the substitutions of high value species with species of low commercial value, and to assess the health risk of consumers related to cadmium (Cd), lead (Pb) and mercury (Hg) contents. Species authentication was evaluated with amplification of COI DNA barcode and confirmed the declared species. Among tested metals, Hg had the highest concentrations, followed by Cd and Pb...
March 24, 2017: Molecular Medicine Reports
https://www.readbyqxmd.com/read/28330725/a-botanical-phytochemical-and-ethnomedicinal-review-of-the-genus-mitragyna-korth-implications-for-products-sold-as-kratom
#17
REVIEW
Paula N Brown, Jensen A Lund, Susan J Murch
ETHNOPHARMACOLOGICAL RELEVANCE: The genus Mitragyna (Rubiacaeae) has been traditionally used in parts of Africa, Asia and Oceania. In recent years, there has been increased interest in species of Mitragyna with the introduction of products to western markets and regulatory uncertainty. AIM OF THE STUDY: This paper reviewed the traditional ethnomedicinal uses of leaves for species belonging to the genus Mitragyna with reference to the botany and known chemistry in order to highlight areas of interest for products currently being sold as kratom...
March 18, 2017: Journal of Ethnopharmacology
https://www.readbyqxmd.com/read/28329812/response-to-does-glp-enhance-the-quality-of-toxicological-evidence-for-regulatory-decisions
#18
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
#19
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 18, 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
#20
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
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