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Regulatory toxicology

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https://www.readbyqxmd.com/read/28796812/toxicological-and-bio-distribution-profile-of-a-gm-csf-expressing-double-targeted-chimeric-oncolytic-adenovirus-oncos-102-support-for-clinical-studies-on-advanced-cancer-treatment
#1
Lukasz Kuryk, Lotta Vassilev, Tuuli Ranki, Akseli Hemminki, Aila Karioja-Kallio, Onerva Levälampi, Antti Vuolanto, Vincenzo Cerullo, Sari Pesonen
The purpose of this work was to carry out preclinical toxicity and bio-distribution studies required for regulatory approval of a clinical trial application for Phase I clinical studies of ONCOS-102 (Ad5/3-D24-GM-CSF) for therapy of advanced cancers (NCT01598129). The study design, route of administration and dosage differs from the clinical protocol and in more detail, investigate bio-distribution and toxicological profile of ONCOS-102 treatment in animal model. The study was carried out in 300 hamsters divided into nine test groups-three bio-distribution groups and six groups for analysis of toxicity...
2017: PloS One
https://www.readbyqxmd.com/read/28772059/optical-projection-tomography-with-a-tissue-clearing-agent-for-developmental-and-reproductive-toxicology-studies
#2
Alexander W Magsam, Michael Johnson, Thomas Villani, Mark C Pierce
BACKGROUND: Developmental and reproductive toxicology (DART) testing represents an expensive and time-consuming stage in determining the toxicological profile of new chemical entities. Within DART studies, morphological evaluation of fetal skeletons for developmental abnormalities typically requires 7 to 14 days. Current processing techniques involve digestion of soft tissue using a strong base (KOH), followed by qualitative assessment of the remaining skeletal tissue by a fetal morphologist...
August 3, 2017: Birth defects research
https://www.readbyqxmd.com/read/28760446/in-vitro-to-in-vivo-extrapolation-of-effective-dosimetry-in-developmental-toxicity-testing-application-of-a-generic-pbk-modelling-approach
#3
Styliani Fragki, Aldert H Piersma, Emiel Rorije, Marco J Zeilmaker
Incorporation of kinetics to quantitative in vitro to in vivo extrapolations (QIVIVE) is a key step for the realization of a non-animal testing paradigm, in the sphere of regulatory toxicology. The use of Physiologically-Based Kinetic (PBK) modelling for determining systemic doses of chemicals at the target site is accepted to be an indispensable element for such purposes. Nonetheless, PBK models are usually designed for a single or a group of compounds and are considered demanding, with respect to experimental data needed for model parameterization...
July 28, 2017: Toxicology and Applied Pharmacology
https://www.readbyqxmd.com/read/28757310/recommendations-for-harmonization-of-data-collection-and-analysis-of-developmental-neurotoxicity-endpoints-in-regulatory-guideline-studies-proceedings-of-workshops-presented-at-society-of-toxicology-and-joint-teratology-society-and-neurobehavioral-teratology
#4
REVIEW
Abby A Li, Larry P Sheets, Kathleen Raffaele, Virginia Moser, Angela Hofstra, Alan Hoberman, Susan L Makris, Robert Garman, Brad Bolon, Wolfgang Kaufmann, Roland Auer, Edmund Lau, Thomas Vidmar, Wayne J Bowers
The potential for developmental neurotoxicity (DNT) of environmental chemicals may be evaluated using specific test guidelines from the US Environmental Protection Agency or the Organisation for Economic Cooperation and Development (OECD). These guidelines generate neurobehavioral, neuropathological, and morphometric data that are evaluated by regulatory agencies globally. Data from these DNT guideline studies, or the more recent OECD extended one-generation reproductive toxicity guideline, play a pivotal role in children's health risk assessment in different world areas...
July 27, 2017: Neurotoxicology and Teratology
https://www.readbyqxmd.com/read/28751261/getting-a-molecule-into-the-clinic-nonclinical-testing-and-starting-dose-considerations
#5
Paul Baldrick
Examination of content of 35 Investigator Brochures (IBs) for small molecules (including some for oncology) used to support First-In-Human studies over a 2 year period (2014-2016) showed that a mean of 37 nonclinical studies were performed per molecule with pharmacology, ADME and toxicology testing contributing 43%, 32% and 24% of the studies, respectively. Examination of 11 IBs for biopharmaceuticals (monoclonal antibodies) over the same time frame showed that the mean number of nonclinical studies was 17 studies per molecule with pharmacology, ADME and toxicology testing contributing 82%, 6% and 12% of the studies, respectively...
July 24, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28749665/summary-of-the-acs-symposium-public-health-perspectives-of-mycotoxins-in-food
#6
Lauren S Jackson, Dojin Ryu
A symposium entitled "Public Health Perspectives of Mycotoxins in Food" was held at the 251st American Chemical Society Meeting in March 2016 in San Diego, CA and was sponsored by the ACS Division of Agricultural and Food Chemistry. The purpose of the symposium was to convene the leading mycotoxin researchers throughout the world to discuss the current state of knowledge as well as research needs with respect to evaluating the toxicological properties of mycotoxins, and ways to detect, control and reduce human and animal exposure to these natural toxins...
July 27, 2017: Journal of Agricultural and Food Chemistry
https://www.readbyqxmd.com/read/28748456/nonclinical-development-of-combination-drugs
#7
Alberto Lodola
We define "combination drugs" as "fixed-dose combinations" (FDCs), that is, two or more drugs (marketed or not) combined in a single pill or two or more separate drugs packaged together. FDCs have been available commercially for many years but only relatively recently have nonclinical development guidelines been released by a number of regulatory authorities and the World Health Organization; as yet there are no ICH guidelines specific to combination drugs. In general however, the ICH guidelines for monotherapy development provide a framework for FDC development...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28714573/assessment-of-the-dna-damaging-potential-of-environmental-chemicals-using-a-quantitative-high-throughput-screening-approach-to-measure-p53-activation
#8
Kristine L Witt, Jui-Hua Hsieh, Stephanie L Smith-Roe, Menghang Xia, Ruili Huang, Jinghua Zhao, Scott S Auerbach, Junguk Hur, Raymond R Tice
Genotoxicity potential is a critical component of any comprehensive toxicological profile. Compounds that induce DNA or chromosomal damage often activate p53, a transcription factor essential to cell cycle regulation. Thus, within the US Tox21 Program, we screened a library of ∼10,000 (∼8,300 unique) environmental compounds and drugs for activation of the p53-signaling pathway using a quantitative high-throughput screening assay employing HCT-116 cells (p53(+/+) ) containing a stably integrated β-lactamase reporter gene under control of the p53 response element (p53RE)...
July 17, 2017: Environmental and Molecular Mutagenesis
https://www.readbyqxmd.com/read/28699487/mixed-matrix-method-provides-a-reliable-metabolite-exposure-comparison-for-assessment-of-metabolite-in-safety-testing-mist
#9
Ryan Takahashi, Cyrus Khojasteh, Matthew Wright, Cornelis Hop, Shuguang Ma
The regulatory guidances on metabolites in safety testing (MIST) by US Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) describe the necessity to assess exposures of circulating metabolites in humans at steady state relative to exposures achieved in nonclinical safety studies prior to the initiation of large scale clinical trials. This comparison can be accomplished by measuring metabolite concentrations in animals and humans with validated bioanalytical methods. However, bioanalysis of metabolites in multiple species and multiple studies is resource intensive and may impact the timelines of clinical studies...
July 10, 2017: Drug Metabolism Letters
https://www.readbyqxmd.com/read/28699400/regulatory-forum-opinion-piece-effective-sectioning-of-spinal-cord-during-regulatory-type-nonclinical-toxicity-studies
#10
Brad Bolon
Regulatory guidelines for nonclinical neurotoxicity testing require spinal cord evaluation but do not specify a trimming scheme. The Society of Toxicologic Pathology (STP) "best practices" for nervous system sampling during nonclinical general toxicity studies recommend that spinal cord be assessed in both longitudinal/oblique and transverse sections. This article defines possible longitudinal/oblique orientations, describes their benefits and challenges, and provides an expert recommendation regarding suitable trimming planes...
January 1, 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28695774/regulatory-risk-assessments-is-there-a-need-to-reduce-uncertainty-and-enhance-robustness-update-on-propylparaben-in-relation-to-its-eu-regulatory-status
#11
D Snodin
Over 10 years ago, propylparaben (propyl- p-hydroxybenzoate; PP) was withdrawn as a permitted food preservative in the EU based entirely on findings reported in a single dietary study in juvenile rats claiming to show adverse effects on male reproductive parameters [Oishi S. Effects of propyl paraben on the male reproductive system. Food Chem Toxicol 2002; 40(12): 1807 -1813]. Subsequent data reviews have cast serious doubt on the validity of the Oishi results, mainly in relation to aberrant concurrent-control values, and in two further comprehensive studies using neonatal and juvenile rats there were no adverse effects in males at oral doses up to 1000 mg/kg/day...
January 1, 2017: Human & Experimental Toxicology
https://www.readbyqxmd.com/read/28692439/lipid-emulsion-in-local-anesthetic-toxicity
#12
Martyn Harvey, Grant Cave
PURPOSE OF REVIEW: Enthusiasm for regional anesthesia has been driven by multimodal benefits to patient outcomes. Despite widespread awareness and improved techniques (including the increasing use of ultrasound guidance for block placement), intravascular sequestration and the attendant risk of local anesthetic systemic toxicity (LAST) remains. Intravenous lipid emulsion (ILE) for the treatment of LAST has been endorsed by anesthetic regulatory societies on the basis of animal study and human case report data...
July 7, 2017: Current Opinion in Anaesthesiology
https://www.readbyqxmd.com/read/28689746/steps-towards-the-international-regulatory-acceptance-of-non-animal-methodology-in-safety-assessment
#13
Fiona Sewell, John Doe, Nichola Gellatly, Ian Ragan, Natalie Burden
The current animal-based paradigm for safety assessment must change. In September 2016, the UK National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) brought together scientists from regulatory authorities, academia and industry to review progress in bringing new methodology into regulatory use, and to identify ways to expedite progress. Progress has been slow. Science is advancing to make this possible but changes are necessary. The new paradigm should allow new methodology to be adopted once it is developed rather than being based on a fixed set of studies...
July 8, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28684318/the-juvenile-toxicity-study-as-a-tool-for-a-science-based-risk-assessment-in-the-children-population-group
#14
REVIEW
Laura Narciso, Tiziana Catone, Gabriele Aquilina, Leonello Attias, Isabella De Angelis, Maria Grazia Iuliano, Roberta Tassinari, Alberto Mantovani, Francesca Maranghi
Children show unique features concerning chemical hazards and risks, due to different exposure scenarios, age-related metabolic capacity and biological susceptibility linked to post-natal development. Chemical Regulatory frameworks state the need of children risk characterization. Current testing guidelines covering post-natal development are not routinely required by regulatory applications other than pesticides and biocides. Juvenile toxicity studies are foreseen for paediatric drugs: the toxicological repeated-dose tests don't allow accurate evaluations of effects upon direct exposure of immature organism...
July 3, 2017: Reproductive Toxicology
https://www.readbyqxmd.com/read/28681657/fatal-poisoning-by-terbufos-following-occupational-exposure
#15
Yue Liang, Fang Tong, Lin Zhang, Wenhe Li, Weisheng Huang, Yiwu Zhou
CONTEXT: Terbufos (TBF) is a class Ia (extremely hazardous) organophosphate pesticide (OP) and its distribution in industrialized countries has been severely restricted. Thus, acute occupational poisoning is rather uncommon. However, it still occurs in rural areas of some developing countries, where the sale of TBF is not controlled and its use is thus not properly regulated. We report a case of a 43-year-old female farmer who died after applying TBF granules. CASE: The patient died within 3 h after applying 20 bags of 5% TBF granules (900 g per bag)...
July 6, 2017: Clinical Toxicology
https://www.readbyqxmd.com/read/28677675/probabilistic-dietary-risk-assessment-of-pesticide-residues-in-foods-for-the-german-population-based-on-food-monitoring-data-from-2009-to-2014
#16
Christian Sieke, Britta Michalski, Thomas Kuhl
Dietary risks for the German population owing to pesticide residues in foods were assessed based on food monitoring data, consumption surveys for children and adults and compound specific toxicological reference values or general thresholds of toxicological concern. A tiered probabilistic modelling was conducted to screen 700 pesticides for significant long- and short-term dietary exposures. Especially for the short-term dietary exposure, the probabilistic methodology used allows simultaneous consideration of the complete daily consumption, whereas most regulatory bodies still rely on single commodity approaches...
July 5, 2017: Journal of Exposure Science & Environmental Epidemiology
https://www.readbyqxmd.com/read/28668334/a-retrospective-analysis-of-in%C3%A2-vivo-eye-irritation-skin-irritation-and-skin-sensitisation-studies-with-agrochemical-formulations-setting-the-scene-for-development-of-alternative-strategies
#17
M Corvaro, S Gehen, K Andrews, R Chatfield, F Macleod, J Mehta
Analysis of the prevalence of health effects in large scale databases is key in defining testing strategies within the context of Integrated Approaches on Testing and Assessment (IATA), and is relevant to drive policy changes in existing regulatory toxicology frameworks towards non-animal approaches. A retrospective analysis of existing results from in vivo skin irritation, eye irritation, and skin sensitisation studies on a database of 223 agrochemical formulations is herein published. For skin or eye effects, high prevalence of mild to non-irritant formulations (i...
June 28, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28654780/development-and-validation-of-an-icp-ms-method-for-the-determination-of-elemental-impurities-in-tp-6076-active-pharmaceutical-ingredient-api-according-to-usp-%C3%A2-232%C3%A2-%C2%AA-%C3%A2-233%C3%A2-%C2%AA
#18
Osama Chahrour, John Malone, Mark Collins, Vrushali Salmon, Catherine Greenan, Amy Bombardier, Zhongze Ma, Nick Dunwoody
The new guidelines of the United States pharmacopeia (USP), European pharmacopeia (EP) and international conference on harmonization (ICH) regulating elemental impurities limits in pharmaceuticals signify the end of unspecific analysis of metals as outlined in USP 〈231〉. The new guidelines specify both daily doses and concentration/limits of elemental impurities in pharmaceutical final products, active pharmaceutical ingredients (API) and excipients. In chapter USP 〈233〉 method implementation, validation and quality control during the analytical process are described...
June 20, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28645863/toxicology-of-octamethylcyclotetrasiloxane-d4
#19
Allison Franzen, Tracy Greene, Cynthia Van Landingham, Robinan Gentry
Octamethylcyclotetrasiloxane (D4) is a volatile cyclic siloxane used primarily as a monomer or intermediate in the production of some silicon-based polymers widely used in industrial and consumer applications and may be present as a residual impurity in a variety of consumer products. A robust toxicological data set exists for D4. Treatment-related results from a chronic inhalation study conducted in rats are limited to mild effects on the respiratory tract, increases in liver weight, increases in the incidence of uterine endometrial epithelial hyperplasia, and a dose-related trend in the incidence of endometrial adenomas...
June 20, 2017: Toxicology Letters
https://www.readbyqxmd.com/read/28641506/regulatory-forum-opinion-piece-imaging-applications-in-toxicologic-pathology-recommendations-for-use-in-regulated-nonclinical-toxicity-studies
#20
Robert R Maronpot, Abraham Nyska, Sean P Troth, Kathleen Gabrielson, Polina Sysa-Shah, Vyacheslav Kalchenko, Yuri Kuznetsov, Alon Harmelin, Yael S Schiffenbauer, David Bonnel, Jonathan Stauber, Yuval Ramot
Available imaging systems for use in preclinical toxicology studies increasingly show utility as important tools in the toxicologic pathologist's armamentarium, permit longitudinal evaluation of functional and morphological changes in tissues, and provide important information such as organ and lesion volume not obtained by conventional toxicology study parameters. Representative examples of practical imaging applications in toxicology research and preclinical studies are presented for ultrasound, positron emission tomography/single-photon emission computed tomography, optical, magnetic resonance imaging, and matrix-assisted laser desorption ionization-imaging mass spectrometry imaging...
June 2017: Toxicologic Pathology
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