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Regulatory Toxicology and Pharmacology: RTP

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https://www.readbyqxmd.com/read/28634147/csahi-study-2-validation-of-multi-electrode-array-systems-mea60-2100-for-prediction-of-drug-induced-proarrhythmia-using-human-ips-cell-derived-cardiomyocytes-assessment-of-reference-compounds-and-comparison-with-non-clinical-studies-and-clinical-information
#1
Yumiko Nozaki, Yayoi Honda, Hitoshi Watanabe, Shota Saiki, Kiyotaka Koyabu, Tetsuji Itoh, Chiho Nagasawa, Chiaki Nakamori, Chiaki Nakayama, Hiroshi Iwasaki, Shinobu Suzuki, Kohji Tanaka, Etsushi Takahashi, Kaori Miyamoto, Kaoru Morimura, Atsuhiro Yamanishi, Hiroko Endo, Junko Shinozaki, Hisashi Nogawa, Tadahiro Shinozawa, Fumiyo Saito, Takeshi Kunimatsu
With the aim of reconsidering ICH S7B and E14 guidelines, a new in vitro assay system has been subjected to worldwide validation to establish a better prediction platform for potential drug-induced QT prolongation and the consequent TdP in clinical practice. In Japan, CSAHi HEART team has been working on hiPS-CMs in the MEA (hiPS-CMs/MEA) under a standardized protocol and found no inter-facility or lot-to-lot variability for proarrhythmic risk assessment of 7 reference compounds. In this study, we evaluated the responses of hiPS-CMs/MEA to another 31 reference compounds associated with cardiac toxicities, and gene expression to further clarify the electrophysiological characteristics over the course of culture period...
June 17, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28634146/sub-chronic-oral-toxicity-of-cuminum-cyminum-l-s-essential-oil-in-female-wistar-rats
#2
Mohsen Taghizadeh, Seyed Naser Ostad, Zatollah Asemi, Mohaddese Mahboubi, Sara Hejazi, Reza Sharafati-Chaleshtori, Aliakbar Rashidi, Hosein Akbari, Nasrin Sharifi
The current study was performed to evaluate the toxicity of Cuminum cyminum L. (C. cyminum)'s essential oil after 23 days and 45 days of repeated oral administration in female Wistar rats. A total of 80 healthy female Wistar rats were randomly selected and divided into 4 groups. The rats were gavaged with C. cyminum's essential oil at dose levels of 0, 250, 500 and 1000 mg/kg/day. Clinical signs, body weight, hematology, serum biochemistry and organ histopathology were assessed once after 23 days and again after 45 days passed from the start of the intervention...
June 17, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28625913/use-of-rodent-data-for-cancer-risk-assessment-of-smokeless-tobacco-in-the-regulatory-context
#3
Robert Nilsson
To support risk management decisions, information from different fields has been integrated in this presentation to provide a realistic quantitative cancer risk assessment of smokeless tobacco. Smoking among Swedish men is currently below 10%, while about 20% use a special smokeless tobacco (snus) as a substitute for cigarettes. Epidemiological data and molecular biomarkers demonstrate that rodent bioassays with tobacco specific nitrosamines (TSNA) overestimate cancer risk from snus by more than one order of magnitude...
June 15, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28624430/comparative-assessment-of-immune-complex-mediated-hypersensitivity-reactions-with-biotherapeutics-in-the-non-human-primate-critical-parameters-safety-and-lessons-for-future-studies
#4
Sven Kronenberg, Elisabeth Husar, Christine Schubert, Christian Freichel, Thomas Emrich, Martin Lechmann, Anna Maria Giusti, Franziska Regenass
With the emergence of novel biotherapeutic formats and immunostimulatory biotherapeutics in cancer immunotherapy, an understanding of immune-complex (IC) mediated hypersensitivity reactions in toxicology studies - and their differentiation from pharmacology - remains key to the preclinical evaluation of these drugs. In this review we provide an in-depth evaluation and comparison of case examples where IC-mediated hypersensitivity reactions were observed in cynomolgus monkeys. We provide details of the parameters evaluated in each study to substantiate and guide the interpretation of these findings...
June 15, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28619682/air-quality-and-acute-deaths-in-california-2000-2012
#5
S Stanley Young, Richard L Smith, Keneth K Lopiano
Many studies have shown an association between air quality and acute deaths, and such associations are widely interpreted as causal. Several factors call causation and even association into question, for example multiple testing and multiple modeling, publication bias and confirmation bias. Many published studies are difficult or impossible to reproduce because of lack of access to confidential data sources. Here we make publically available a dataset containing daily air quality levels, PM2.5 and ozone, daily temperature levels, minimum and maximum and daily maximum relative humidity levels for the eight most populous California air basins, thirteen years, >2M deaths, over 37,000 exposure days...
June 12, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28602621/binary-test-battery-with-keratinosens%C3%A2-and-h-clat-as-part-of-a-bottom-up-approach-for-skin-sensitization-hazard-prediction
#6
Yuki Otsubo, Taku Nishijo, Masaaki Miyazawa, Kazutoshi Saito, Hideyuki Mizumachi, Hitoshi Sakaguchi
Skin sensitization is one of the key safety endpoints for chemicals applied directly to the skin. Several integrated testing strategies (ITS) using multiple non-animal test methods have been developed to accurately evaluate the sensitizing potential of chemicals, but there is no regulatory-accepted ITS to classify a chemical as a non-sensitizer. In this study, the predictive performance of a binary test battery with KeratinoSens™ and h-CLAT compared to the local lymph node assay (LLNA) and human data was examined using comprehensive dataset of 203 chemicals...
June 7, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28592367/corrigendum-to-safety-assessment-and-attenuation-of-cisplatin-induced-nephrotoxicity-by-tuberous-roots-of-boerhaavia-diffusa-regul-toxicol-and-pharmacol-81-2016-341-352
#7
Ritu Karwasra, Prerna Kalra, T C Nag, Y K Gupta, Surender Singh, Anuj Panwar
No abstract text is available yet for this article.
June 5, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28583667/dietary-safety-of-a-dual-enzyme-preparation-for-animal-feed-acute-and-subchronic-oral-toxicity-and-genotoxicity-studies
#8
G P Dillon, M A Gaffney, C M Curran, C A Moran
Animal feed is routinely supplemented with exogenous enzymes to improve nutrient utilization, such as proteases to enhance protein hydrolysis in vivo and xylanases to alleviate feed related anti-nutritional factors. The present studies were conducted to evaluate the potential oral toxicity and genotoxicity of a dual-enzyme preparation, Vegpro(®) concentrate (VPr-C). Acute oral toxicity studies were conducted in adult male and female Sprague-Dawley Crl CD rats and CHS Swiss ICO:OFI (IOPS Caw) mice. Thirteen week preliminary and final subchronic oral toxicity studies were conducted in male and female rats...
June 3, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28583666/safety-evaluation-of-water-soluble-palm-fruit-bioactives
#9
Barry S Lynch, Spencer West, Ashley Roberts
Water-soluble palm fruit bioactives, derived from the aqueous stream of palm oil processing, have shown anti-diabetogenic effects in rodent models. To assess the safety of potential incorporation of this polyphenol-containing material in food, in vitro bacterial reverse mutation and in vitro chromosome aberration assays were conducted along with a 90-day subchronic toxicity study in Sprague-Dawley rats. Water-soluble palm fruit bioactives were inactive in the Ames and in vitro chromosome aberration assays up to the limit doses of 5000 μg/plate and 5000 μg/mL, respectively...
June 2, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28559157/integrating-habits-and-practices-data-for-soaps-cosmetics-and-air-care-products-into-an-existing-aggregate-exposure-model
#10
D Comiskey, A M Api, C Barrett, G Ellis, C McNamara, C O'Mahony, S H Robison, J Rose, B Safford, B Smith, S Tozer
In order to accurately assess aggregate exposure to a fragrance material in consumers, data are needed on consumer habits and practices, as well as the concentration of the fragrance material in those products. The present study describes the development of Phase 2 Creme RIFM model by expanding the previously developed Phase 1 model to include an additional six product types. Using subject-matching algorithms, the subjects in the Phase 1 Creme RIFM database were paired with subjects in the SUPERB and BodyCare surveys based on age and gender...
May 27, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28559156/dietary-safety-assessment-of-genetically-modified-rice-eh-rich-in-%C3%AE-carotene
#11
Yangyang Wu, Yan Xu, Yanan Du, Xiao Zhao, Ruili Hu, Xiaorui Fan, Fangfang Ren, Quanhong Yao, Rihe Peng, Xueming Tang, Kai Zhao
This 90-day study aimed to assess the dietary safety of transgenic rice EH which is rich in β-carotene. Two experimental groups of Sprague-Dawley rats were fed diets containing 45% rice flour of Zhonghua 11 rice and transgenic rice EH rich in β-carotene, respectively. The reference group was fed a diet containing standard feed nutrition. During the trial period, each rat was weighed and the food intake was recorded twice a week. Their behaviors were observed daily. In the end, blood samples were obtained from all anesthetized rats to measure the hematologic and serum chemistry indicators...
May 27, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28554823/mercury-contamination-in-facial-skin-lightening-creams-and-its-health-risks-to-user
#12
Yu Bin Ho, Nor Hidayu Abdullah, Hazwanee Hamsan, Eugenie Sin Sing Tan
This study aims to determine concentrations of mercury in facial skin lightening cream according to different price categories (category I: <RM29.99, category II: RM30.00-RM59.99, category III: RM60.00-RM99.99 and category IV: ≥RM100.00) and their potential health risks to users. Prices of skin lightening creams were determined during a preliminary market survey. Thereafter, twenty samples were purchased from various locations such as cosmetic stalls, beauty shops, pharmacies and street vendors based on their stratified price categories...
May 26, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28549899/utility-of-published-dna-reactivity-alerts
#13
Alun Myden, Sebastien J Guesne, Alex Cayley, Richard V Williams
The identification of impurities with mutagenic potential is required for any potential pharmaceutical. The ICH M7 guidelines state that two complementary in silico toxicity prediction tools may be used to predict the mutagenic potential of pharmaceutical impurities. An expert review of the resulting in silico predictions is required, and numerous publications have been released to guide the expert review process. One such publication suggests that literature-based structural alerts (LBSAs) may provide a suitable aid in the expert review process...
May 23, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28545776/probabilistic-derivation-of-the-interspecies-assessment-factor-for-skin-sensitization
#14
W Bil, A G Schuur, J Ezendam, B G H Bokkers
An interspecies sensitization assessment factor (SAF) is used in the quantitative risk assessment (QRA) for skin sensitization when a murine-based NESIL (No Expected Sensitization Induction Level) is taken as point of departure. Several studies showed that, on average, the murine sensitization threshold is in good correspondence with that determined in humans. However, on an individual level, the murine and human sensitization thresholds may differ considerably. In this study, the interspecies SAF was quantified by using a probabilistic approach, to be able to take these cases into account...
May 22, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28526659/framework-for-assessing-causality-of-air-pollution-related-health-effects-for-reviews-of-the-national-ambient-air-quality-standards
#15
Elizabeth Oesterling Owens, Molini M Patel, Ellen Kirrane, Thomas C Long, James Brown, Ila Cote, Mary A Ross, Steven J Dutton
To inform regulatory decisions on the risk due to exposure to ambient air pollution, consistent and transparent communication of the scientific evidence is essential. The United States Environmental Protection Agency (U.S. EPA) develops the Integrated Science Assessment (ISA), which contains evaluations of the policy-relevant science on the effects of criteria air pollutants and conveys critical science judgments to inform decisions on the National Ambient Air Quality Standards. This article discusses the approach and causal framework used in the ISAs to evaluate and integrate various lines of scientific evidence and draw conclusions about the causal nature of air pollution-induced health effects...
May 17, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28526658/nonclinical-pharmacology-and-toxicology-of-the-first-biosimilar-insulin-glargine-drug-product-basaglar-%C3%A2-abasaglar-%C3%A2-approved-in-the-european-union
#16
Richard A Byrd, Rebecca A Owens, Jamie L Blackbourne, David E Coutant, Mark W Farmen, M Dodson Michael, Julie S Moyers, A Eric Schultze, Michael K Sievert, Niraj K Tripathi, John L Vahle
Basaglar(®)/Abasaglar(®) (Lilly insulin glargine [LY IGlar]) is a long-acting human insulin analogue drug product granted marketing authorisation as a biosimilar to Lantus(®) (Sanofi insulin glargine [SA IGlar]) by the European Medicines Agency. We assessed the similarity of LY IGlar to the reference drug product, European Union-sourced SA IGlar (EU-SA IGlar), using nonclinical in vitro and in vivo studies. No biologically relevant differences were observed for receptor binding affinity at either the insulin or insulin-like growth factor-1 (IGF-1) receptors, or in assays of functional or de novo lipogenic activity...
May 17, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28506844/proarrhythmic-risk-assessment-using-conventional-and-new-in%C3%A2-vitro-assays
#17
Sonia Goineau, Vincent Castagné
Drug-induced QT prolongation is a major safety issue in the drug discovery process. This study was conducted to assess the electrophysiological responses of four substances using established preclinical assays usually used in regulatory studies (hERG channel or Purkinje fiber action potential) and a new assay (human-induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs)-field potential). After acute exposure, moxifloxacin and dofetilide concentration-dependently decreased IKr amplitude (IC50 values: 102 μM and 40 nM, respectively) and lengthened action potential (100 μM moxifloxacin: +23% and 10 nM dofetilide: +18%) and field potential (300 μM moxifloxacin: +76% and 10 nM dofetilide: +38%) durations...
May 12, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28506586/corrigendum-to-airborne-asbestos-exposures-associated-with-gasket-and-packing-replacement-a-simulation-study-of-flange-and-valve-repair-work-and-an-assessment-of-exposure-variables-regul-toxicol-pharmacol-71-1-2014-35-51
#18
Amy K Madl, Kathryn D Devlin, Angela L Perez, Dana M Hollins, Dallas M Cowan, Paul K Scott, Katherine White, Thales J Cheng, John L Henshaw
No abstract text is available yet for this article.
May 12, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28502831/a-12-week-randomized-clinical-trial-investigating-the-potential-for-sucralose-to-affect-glucose-homeostasis
#19
V Lee Grotz, Xavier Pi-Sunyer, Daniel Porte, Ashley Roberts, J Richard Trout
The discovery of gut sweet taste receptors has led to speculations that non-nutritive sweeteners, including sucralose, may affect glucose control. A double-blind, parallel, randomized clinical trial, reported here and previously submitted to regulatory agencies, helps to clarify the role of sucralose in this regard. This was primarily an out-patient study, with 4-week screening, 12-week test, and 4-week follow-up phases. Normoglycemic male volunteers (47) consumed ∼333.3 mg encapsulated sucralose or placebo 3x/day at mealtimes...
May 11, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28487066/genotoxicity-acute-and-subchronic-toxicity-evaluation-of-savory-food-ingredients
#20
Shahrzad Tafazoli, Trung D Vo, Anne Petersen, Anne Constable, Myriam Coulet, Phoukham Phothirath, Johanna Lang, Nigel Baldwin
The potential toxicity of two savory food ingredients produced by fermentation of enzymatically hydrolyzed corn starch (Savory Base 100 and Savory Base 200) was evaluated individually in a bacterial reverse mutation assay, an in vitro mammalian cell gene mutation assay, an acute oral study and as a mixture in a 90-day dietary study. In the bacterial reverse mutation and in vitro mammalian cell gene mutation assays, neither ingredient was mutagenic at concentrations up to 5000 μg/plate and 5000 μg/mL, respectively in the presence and absence of metabolic activation...
May 6, 2017: Regulatory Toxicology and Pharmacology: RTP
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