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Regulatory toxicology

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https://www.readbyqxmd.com/read/29155963/generating-modelling-data-from-repeat-dose-toxicity-reports
#1
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
#2
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
#3
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
#4
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
https://www.readbyqxmd.com/read/29130351/the-gene-therapy-resource-program-a-decade-of-dedication-to-translational-research-by-the-national-heart-lung-and-blood-institute
#5
Terence R Flotte, Eric Daniels, Janet Benson, Jenee M Bevett-Rose, Kenneth Cornetta, Margaret Diggins, Julie Johnston, Susan Sepelak, Johannes Van Der Loo, James M Wilson, Cheryl L McDonald
Over a ten-year period, the Gene Therapy Resource Program (GTRP) of the National Heart Lung and Blood Institute (NHLBI) has provided a set of core services to investigators to facilitate the clinical translation of gene therapy. These services have included a preclinical (research-grade) vector production core; current Good Manufacturing Practice (cGMP) clinical-grade vector cores for recombinant adeno-associated virus (rAAV) and lentivirus vectors; a pharmacology and toxicology core; and a coordinating center to manage program logistics and to provide regulatory and financial support to early phase clinical trials...
November 12, 2017: Human Gene Therapy. Clinical Development
https://www.readbyqxmd.com/read/29126988/morinda-officinalis-how-a-comprehensive-review-of-traditional-uses-phytochemistry-and-pharmacology
#6
REVIEW
Jian-Hua Zhang, Hai-Liang Xin, Yue-Ming Xu, Yi Shen, Yu-Qiong He, Hsien-Yeh, Bing Lin, Hong-Tao Song, Juan-Liu, Hai-Yue Yang, Lu-Ping Qin, Qiao-Yan Zhang, Juan Du
ETHNOPHARMACOLOGICAL RELEVANCE: The medicinal plant Morinda officinalisHow. (MO) and its root have long been used in traditional medicines in China and northeast Asia as tonics for nourishing the kidney, strengthening the bone and enhancing immunofunction in the treatment of impotence, osteoporosis, depression and inflammatory diseases such as rheumatoid arthritis and dermatitis. AIM OF THE REVIEW: This review aims to sum up updated and comprehensive information about traditional usage, phytochemistry, pharmacology and toxicology of MO and provide insights intopotential opportunities for future research and development of this plant...
November 7, 2017: Journal of Ethnopharmacology
https://www.readbyqxmd.com/read/29116189/tobacco-papers-and-tobacco-industry-ties-in-regulatory-toxicology-and-pharmacology
#7
Clayton Velicer, Gideon St Helen, Stanton A Glantz
We examined the relationship between the tobacco industry and the journal Regulatory Toxicology and Pharmacology (RTP) using the Truth Tobacco Industry Documents Library and internet sources. We determined the funding relationships, and categorised the conclusions of all 52 RTP papers on tobacco or nicotine between January 2013 and June 2015, as "positive", "negative" or "neutral" for the tobacco industry. RTP's editor, 57% (4/7) of associate editors and 37% (14/38) of editorial board members had worked or consulted for tobacco companies...
November 7, 2017: Journal of Public Health Policy
https://www.readbyqxmd.com/read/29114260/crosstalk-between-receptor-and-non-receptor-mediated-chemical-modes-of-action-in-rat-livers-converges-through-a-dysregulated-gene-expression-network-at-tumor-suppressor-tp53
#8
Karen M Funderburk, Scott S Auerbach, Pierre R Bushel
Chemicals, toxicants, and environmental stressors mediate their biologic effect through specific modes of action (MOAs). These encompass key molecular events that lead to changes in the expression of genes within regulatory pathways. Elucidating shared biologic processes and overlapping gene networks will help to better understand the toxicologic effects on biological systems. In this study we used a weighted network analysis of gene expression data from the livers of male Sprague-Dawley rats exposed to chemicals that elicit their effects through receptor-mediated MOAs (aryl hydrocarbon receptor, orphan nuclear hormone receptor, or peroxisome proliferator-activated receptor-α) or non-receptor-mediated MOAs (cytotoxicity or DNA damage)...
2017: Frontiers in Genetics
https://www.readbyqxmd.com/read/29113941/human-relevance-of-rodent-liver-tumors-key-insights-from-a-toxicology-forum-workshop-on-nongenotoxic-modes-of-action
#9
Susan P Felter, Jennifer E Foreman, Alan Boobis, J Christopher Corton, Adriana M Doi, Lynn Flowers, Jay Goodman, Lynne T Haber, Abigail Jacobs, James E Klaunig, Angela M Lynch, Jonathan Moggs, Arun Pandiri
The Toxicology Forum sponsored a workshop in October 2016, on the human relevance of rodent liver tumors occurring via nongenotoxic modes of action (MOAs). The workshop focused on two nuclear receptor-mediated MOAs (Constitutive Androstane Receptor (CAR) and Peroxisome Proliferator Activated Receptor-alpha (PPARα), and on cytotoxicity. The goal of the meeting was to review the state of the science to (1) identify areas of consensus and differences, data gaps and research needs; (2) identify reasons for inconsistencies in current regulatory positions; and (3) consider what data are needed to demonstrate a specific MOA, and when additional research is needed to rule out alternative possibilities...
November 4, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/29111621/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-total-25-hydroxyvitamin-d-mass-spectrometry-test-system-final-order
#10
(no author information available yet)
The Food and Drug Administration (FDA, the Agency, or we) is classifying the total 25-hydroxyvitamin D mass spectrometry test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the total 25-hydroxyvitamin D mass spectrometry test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
November 7, 2017: Federal Register
https://www.readbyqxmd.com/read/29110904/retention-of-gadolinium-compounds-used-in-magnetic-resonance-imaging-a-critical-review-and-the-recommendations-of-regulatory-agencies
#11
L Martí-Bonmatí, E Martí-Bonmatí
The Spanish Agency for Drugs and Healthcare Products (AEMPS), based on the recommendations of the European Committee for Risk Assessment in Pharmacovigilance, established on 13 March 2017 that linear gadolinium-based MR contrast media, such as MultiHance, Omniscan, Magnevist (currently not marketed) and Optimark (no longer marketed in Spain), the clinical benefits do not outweigh the potential risks derived from their use. AEMPS recommends to suspend its marketing for general use based on the retention of these compounds in the brain...
October 27, 2017: Radiología
https://www.readbyqxmd.com/read/29108483/bone-therapeutics-safety-considerations-session-summary
#12
Christopher P Jerome, Rogely Boyce
This session was a series of presentations focused on safety considerations for late stage or currently marketed bone therapeutic agents. The first presentation was an overview of a major regulatory requirement in the nonclinical filing package for bone therapeutics, studies designed to assess the impact of an agent on bone quality. Two presentations focused on safety issues associated with drugs whose primary mechanism of action is inhibition of bone resorption. Typical findings associated with this class of agents in general and reproductive toxicology studies were reviewed, highlighting INHAND (International Harmonization of Nomenclature and Diagnostic Criteria) nomenclature...
January 1, 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/29105580/a-brief-overview-of-the-stp-36th-annual-symposium-musculoskeletal-system
#13
Kathryn E Gropp, Michael C Boyle
The title of the 2017 Society of Toxicologic Pathology symposium was "Musculoskeletal System." A brief overview of the General Scientific Symposium is presented herein and describes the topics presented by each speaker. Symposium speakers addressed subjects pertinent to musculoskeletal system toxicologic pathology and drug development ranging from molecular biology of bone homeostasis to regulatory agency requirements and considerations for registration of bone therapeutics. This overview serves to summarize sessions and is intended as a guide to the individual submissions by speakers and symposium contributors...
January 1, 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/29105579/bone-and-joint-medical-devices-methods-models-and-regulations
#14
Lyn M Wancket
Repair of bone and joint tissue to restore normal function is a unique endeavor that requires recreating tissue structure and the integrated healing of both organic and inorganic tissue components. Session 5 (Structural approaches to bone and joint repair) at the 36th annual Society of Toxicologic Pathology Annual Symposium included 2 talks covering methods, models, and regulatory considerations used to evaluate novel approaches for repairing bones and joints. Lyn Wancket provided a general overview of medical devices, with an emphasis on preclinical and clinical evaluations of bone and joint devices...
January 1, 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/29101769/computational-approaches-to-chemical-hazard-assessment
#15
Thomas Luechtefeld, Thomas Hartung
Computational prediction of toxicity has reached new heights as a result of decades of growth in the magnitude and diversity of biological data. Public packages for statistics and machine learning make model creation faster. New theory in machine learning and cheminformatics enables integration of chemical structure, toxicogenomics, simulated and physical data in the prediction of chemical health hazards, and other toxicological information. Our earlier publications have characterized a toxicological dataset of unprecedented scale resulting from the European REACH legislation (Registration Evaluation Authorisation and Restriction of Chemicals)...
2017: ALTEX
https://www.readbyqxmd.com/read/29091368/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-acute-kidney-injury-test-system-final-order
#16
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the acute kidney injury test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the acute kidney injury test system's classification. We are taking this action because we have determined that classifying the device into class II (special 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...
October 30, 2017: Federal Register
https://www.readbyqxmd.com/read/29076627/forensic-toxicology-perspectives-of-methadone-associated-deaths-in-tehran-iran-a-seven-year-overview
#17
Maryam Akhgari, Noushin Amini-Shirazi, Fariba Sardari Iravani
Methadone has a long history of pain relief and successful substitute for maintenance treatment in heroin and narcotic addiction. The aim of the study was to assess the trends of methadone-associated deaths in Tehran, Iran, in 2009-2015, from a forensic toxicology point of view. All methadone-associated deaths during this 7-year study period were evaluated according to demographic parameters and forensic toxicology analysis results. Results showed that 1274 cases of methadone-associated deaths were investigated during the study period...
October 27, 2017: Basic & Clinical Pharmacology & Toxicology
https://www.readbyqxmd.com/read/29074277/physico-chemical-properties-of-manufactured-nanomaterials-characterisation-and-relevant-methods-an-outlook-based-on-the-oecd-testing-programme
#18
Kirsten Rasmussen, Hubert Rauscher, Agnieszka Mech, Juan Riego Sintes, Douglas Gilliland, Mar González, Peter Kearns, Kenneth Moss, Maaike Visser, Monique Groenewold, Eric A J Bleeker
Identifying and characterising nanomaterials require additional information on physico-chemical properties and test methods, compared to chemicals in general. Furthermore, regulatory decisions for chemicals are usually based upon certain toxicological properties, and these effects may not be equivalent to those for nanomaterials. However, regulatory agencies lack an authoritative decision framework for nanomaterials that links the relevance of certain physico-chemical endpoints to toxicological effects. This paper investigates various physico-chemical endpoints and available test methods that could be used to produce such a decision framework for nanomaterials...
October 23, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/29071358/tracing-the-evolutionary-history-of-the-cap-superfamily-of-proteins-using-amino-acid-sequence-homology-and-conservation-of-splice-sites
#19
Anup Abraham, Douglas E Chandler
Proteins of the CAP superfamily play numerous roles in reproduction, innate immune responses, cancer biology, and venom toxicology. Here we document the breadth of the CAP (Cysteine-RIch Secretory Protein (CRISP), Antigen 5, and Pathogenesis-Related) protein superfamily and trace the major events in its evolution using amino acid sequence homology and the positions of exon/intron borders within their genes. Seldom acknowledged in the literature, we find that many of the CAP subfamilies present in mammals, where they were originally characterized, have distinct homologues in the invertebrate phyla...
October 2017: Journal of Molecular Evolution
https://www.readbyqxmd.com/read/29065848/cytotoxicity-of-nanomaterials-nanotoxicology-to-address-the-safety-concerns-of-nanoparticles
#20
Mohd Aslam Saifi, Wahid Khan, Chandraiah Godugu
BACKGROUND: The rapid progress in the application of different types of nanoparticles in various biomedical applications resulted in substantial increase in use of these materials. The special physicochemical properties like small size and increased surface area offered by nanoparticles may pose unexpected toxicological threats despite of offering promising biological effects. OBJECTIVE: The intended as well as unintended exposure of nanoparticles to humans is a major challenge for the expanding field of nanoparticle therapy...
October 23, 2017: Pharmaceutical Nanotechnology
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