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Clinical Toxicology

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https://www.readbyqxmd.com/read/29048701/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-organophosphate-test-system-final-order
#1
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the organophosphate 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 organophosphate 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 18, 2017: Federal Register
https://www.readbyqxmd.com/read/29046744/clinical-and-epidemiological-characteristics-of-patients-with-acute-drug-intoxication-admitted-to-icu
#2
Jose Orsini, Nanda Din, Ershad Elahi, Anthony Gomez, Salil Rajayer, Ryan Malik, Elie Jean
Background: Drug overdose continues to be the most common cause of acute poisoning worldwide. There has been a substantial increase in drug overdose incidence and prevalence over the past decade, probably as a result of the emergence of new synthetic designer drugs. The purpose of this study is to describe the clinical and epidemiological characteristics of patients with acute drug intoxication admitted to the Intensive Care Unit (ICU). Methods: A single center, prospective, observational study was conducted among all adult patients with clinical signs suggestive of acute drug intoxication admitted from the Emergency Department (ED) to ICU during a 6-month period (September to March)...
October 2017: Journal of Community Hospital Internal Medicine Perspectives
https://www.readbyqxmd.com/read/29046697/preclinical-safety-assessment-of-angelica-acutiloba-using-a-13-week-repeated-dose-oral-toxicity-study-in-rats
#3
Jun-Won Yun, Euna Kwon, Seung-Hyun Kim, Ji-Ran You, Yun-Soon Kim, In Ae Park, Hyeon Hoe Kim, Jeong-Hwan Che, Byeong-Cheol Kang
Angelica acutiloba (AA), a Japanese species of Danggui, has been used worldwide as a traditional herbal medicine with several bioactivities including anti-diabetic, anti-allergic, anti-inflammatory, anti-tumor, and anti-obesity. However, there is lack of toxicological data available to evaluate potential long-term toxicity and the no-observed-adverse-effect level (NOAEL) of AA extract in accordance with the test guidelines published by the Organization for Economic Cooperation and Development. In the 14-day repeat-dose toxicity study, no adverse effects on mortality, body weight change, clinical signs, and organ weights was found following repeat oral administration to rats for 14 days (125, 250, 500, 1000, and 2000 mg/kg body weight), leading that 2000 mg/kg is the highest recommended dose of AA extract for the 13-week repeat-dose oral toxicity study...
September 2017: Laboratory Animal Research
https://www.readbyqxmd.com/read/29045066/fatality-involving-ocfentanil-documented-by-identification-of-metabolites
#4
Nathalie Allibe, Camille Richeval, Mélodie Phanithavong, Amandine Faure, Delphine Allorge, François Paysant, Françoise Stanke-Labesque, Hélène Eysseric-Guerin, Jean-Michel Gaulier
New psychoactive substances (NPS) use has rapidly increased over the last decade, and in the last 4 years producers increasingly appear to be targeting non-controlled synthetic opioids, involving fentanyl derivatives such as ocfentanil (OcF). Identification of metabolites is of major importance in the context of NPS use as it could improve detection window in biological matrices in clinical and forensic intoxication cases. Hence, this work aims to report a fatality involving OcF documented by the identification of metabolites...
October 16, 2017: Drug Testing and Analysis
https://www.readbyqxmd.com/read/29042291/micrornas-as-biomarkers-for-liver-injury-current-knowledge-challenges-and-future-prospects
#5
REVIEW
Haixia Lin, Laura E Ewing, Igor Koturbash, Bill J Gurley, Isabelle R Miousse
MicroRNAs (miRNAs) are short regulatory RNAs that are involved in various biological processes that regulate gene expression posttranscriptionally. Changes in miRNA expression can be detected in many physiological and pathological events, such as liver injury. Drug induced liver injury is a life threatening condition that frequently requires organ transplantation. Hepatotoxicity is also one of the major causes of drug failure in clinical trials and of drug withdrawal from the market. The profiling of miRNA expression shows great promise in monitoring liver injury, in the prediction of outcome in patients, and in the identification of liver-reactive compounds in toxicological assessment...
October 14, 2017: Food and Chemical Toxicology
https://www.readbyqxmd.com/read/29039319/heavy-metals-identification-and-exposure-at-workplace-environment-its-extent-of-accumulation-in-blood-of-iron-and-steel-recycling-foundry-workers-of-lahore-pakistan
#6
Muhammad Ahsan Riaz, Amtul Bari Tabinda Akhtar, Ayesha Riaz, Ghulam Mujtaba, Muhammad Ali, Beenish Ijaz
The determination of heavy metals in blood is an important occupational environmental toxicology screening procedure. The aim of study was to determine the concentrations of Pb, Cd, Cr and Ni in blood samples of iron and steel foundry workplace exposed workers under routine clinical laboratory conditions. The method was employed for the quantitative determination of lead, cadmium, chromium and nickel in workplace environment particulate matter blood samples from iron and steel foundry workers and in unexposed controls...
July 2017: Pakistan Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29039225/toxicological-impact-of-waterpipe-smoking-and-flavorings-in-the-oral-cavity-and-respiratory-system
#7
Fawad Javed, Shatha Subhi ALHarthi, Munerah Saleh BinShabaib, Sangeeta Gajendra, Georgios E Romanos, Irfan Rahman
Waterpipe smoking (WS), an emerging trend has major health concerns. It is prevalent worldwide as a recreational activity both indoors and outdoors. The aim of this review was to assess the impact of waterpipe smoke on the oral and respiratory system (oral cavity and pulmonary tissues). A number of studies have shown that periodontal health status is compromised in waterpipe smokers when compared with nonsmokers. Some studies have associated WS with oral premalignant and malignant lesions; however, due to the poor quality of these studies, the presented outcomes should be interpreted with caution...
October 17, 2017: Inhalation Toxicology
https://www.readbyqxmd.com/read/29038839/hepatotoxic-combination-effects-of-three-azole-fungicides-in-a-broad-dose-range
#8
T Heise, F Schmidt, C Knebel, S Rieke, W Haider, I Geburek, L Niemann, P Marx-Stoelting
Single active substances of pesticides are thoroughly examined for their toxicity before approval. In this context, the liver is frequently found to be the main target organ. Since consumers are generally exposed to multiple residues of different active substances via the diet, it is important to analyse combinations of active substances for potential mixture effects. For the (tri-)azoles, a group of agricultural fungicides and antifungal drugs, combination effects on the liver are likely because of a similar mode of action...
October 16, 2017: Archives of Toxicology
https://www.readbyqxmd.com/read/29037750/environmental-toxicology-and-omics-a-question-of-sex
#9
Xuefang Liang, April Feswick, Denina Simmons, Christopher J Martyniuk
Molecular initiating events and downstream transcriptional/proteomic responses provide valuable information for adverse outcome pathways, which can be used predict the effects of chemicals on physiological systems. There has been a paucity of research that addresses sex-specific expression profiling in toxicology and due to cost, time, and logistical considerations, sex as a variable has not been widely considered. In response to this deficiency, federal agencies in the United States, Canada, and Europe have highlighted the importance of including sex as a variable in scientific investigations...
October 13, 2017: Journal of Proteomics
https://www.readbyqxmd.com/read/29036912/caustic-ingestion-in-the-elderly-influence-of-age-on-clinical-outcome
#10
Blazena Caganova, Tatiana Foltanova, Erik Puchon, Elena Ondriasova, Silvia Plackova, Tomas Fazekas, Magdalena Kuzelova
Caustic poisonings are still associated with many fatalities. Studies focusing on the elderly are rare. The purpose of the present study was to compare the clinical outcomes of caustic ingestion injury in elderly and non-elderly adults with regard to gender, intent of exposure, substance ingested, severity of mucosal injury, complications, and mortality. Caustic substance exposures reported to the National Toxicological Information Centre in Slovakia during 1998-2015 were reviewed retrospectively. The patients were divided into two groups: the non-elderly (<60 years) and elderly adults (≥60 years)...
October 14, 2017: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
https://www.readbyqxmd.com/read/29036640/toxicokinetics-of-the-synthetic-cathinone-%C3%AE-pyrrolidinohexanophenone
#11
Yuji Fujita, Toshinori Mita, Kiyotaka Usui, Yoshito Kamijo, Satoshi Kikuchi, Makoto Onodera, Yasuhisa Fujino, Yoshihiro Inoue
Synthetic cathinones inhibit monoamine transporters, such as serotonin, norepinephrine, and dopamine transporters, and act on the central nervous system via increasing synaptic concentrations of monoamines. These compounds, which are highly addictive and potentially poisonous, are new psychoactive substances. In this study, we investigated the toxicokinetics of the synthetic cathinone, α-pyrrolidinohexanophenone (α-PHP), and assessed the relationship between the toxicokinetics and the long-term clinical symptoms induced by α-PHP in a male patient...
September 28, 2017: Journal of Analytical Toxicology
https://www.readbyqxmd.com/read/29033634/sudden-unexpected-death-in-epilepsy-a-retrospective-autopsy-study-of-112-epileptic-patients
#12
İpek Esen Melez, Murat Nihat Arslan, Deniz Oğuzhan Melez, Ahmet Necati Şanli, Sermet Koç
INTRODUCTION: Sudden unexpected deaths comprise the most important and worthy investigation case profiles in both neurology and forensic medicine. Epilepsy, which is one of the neuropathological causes of sudden unexpected deaths, is an important disorder having mysterious aspects. The aim of this study is to make common the points of view between neurology and forensic medicine experts and to discuss the features of the findings together with the related clinical hypotheses, leading to the differential diagnosis of sudden unexpected death in epilepsy (SUDEP) by presenting autopsy findings and available medical data of patients who had a prior diagnosis of epilepsy...
September 2017: Noro Psikiyatri Arsivi
https://www.readbyqxmd.com/read/29029591/application-of-microphysiological-systems-to-enhance-safety-assessment-in-drug-discovery
#13
Lorna Ewart, Eva-Maria Dehne, Kristin Fabre, Susan Gibbs, James Hickman, Ellinor Hornberg, Magnus Ingelman-Sundberg, Kyung-Jin Jang, David R Jones, Volker M Lauschke, Uwe Marx, Jerome T Mettetal, Amy Pointon, Dominic Williams, Wolfram-Hubertus Zimmermann, Peter Newham
Enhancing the early detection of new therapies that are likely to carry a safety liability in the context of the intended patient population would provide a major advance in drug discovery. Microphysiological systems (MPS) technology offers an opportunity to support enhanced preclinical to clinical translation through the generation of higher-quality preclinical physiological data. In this review, we highlight this technological opportunity by focusing on key target organs associated with drug safety and metabolism...
October 13, 2017: Annual Review of Pharmacology and Toxicology
https://www.readbyqxmd.com/read/29029351/development-and-application-of-a-dual-rat-and-human-ahr-activation-assay
#14
Martin R Brown, Helen Garside, Emma Thompson, Saseela Atwal, Chloe Bean, Tony Goodall, Michael Sullivan, Mark J Graham
Significant prolonged AHR activation, classically exhibited following exposure to TCDD (dioxin), can cause a variety of undesirable toxicological effects. Novel pharmaceutical chemistries also have the potential to cause activation of AHR and consequent toxicities in pre-clinical species and man. Previous methods either employed relatively expensive and low throughput primary hepatocyte dosing with PCR endpoint, or low resolution overexpressing reporter gene assays. We have developed, validated and applied an in vitro microtitre plate imaging-based medium throughput screening assay for the assessment of endogenous species-specific AHR activation potential via detection of induction of the surrogate transcriptional target Cytochrome P450 CYP1A1...
September 18, 2017: Toxicological Sciences: An Official Journal of the Society of Toxicology
https://www.readbyqxmd.com/read/29029316/the-need-for-and-the-role-of-the-toxicological-chemist-in-the-design-of-safer-chemicals
#15
Stephen C DeVito
During the past several decades there has been an ever increasing emphasis for designers of new commercial (non-pharmaceutical) chemicals to include considerations of the potential impacts a planned chemical may have on human health and the environment as part of the design of the chemical, and to design chemicals such that they possess the desired use efficacy while minimizing threats to human health and the environment. Achievement of this goal would be facilitated by the availability of individuals specifically and formally trained to design such chemicals...
September 18, 2017: Toxicological Sciences: An Official Journal of the Society of Toxicology
https://www.readbyqxmd.com/read/29027369/range-of-therapeutic-prothipendyl-and-prothipendyl-sulfoxide-concentrations-in-clinical-blood-samples
#16
Michael Krämer, Peter Heese, Markus Banger, Burkhard Madea, Cornelius Hess
Due to a lack of reference blood concentrations in the literature, the forensic evaluation of prothipendyl findings in blood samples is difficult. Interpretations with regard to the assessment of blood concentrations as well as an estimation of the ingested prothipendyl amounts were often vague. To describe a concentration range in clinical samples, prothipendyl and prothipendyl sulfoxide concentrations were determined in serum samples of 50 psychiatric patients receiving 40 mg, 80 mg or 160 mg doses of prothipendyl...
October 12, 2017: Drug Testing and Analysis
https://www.readbyqxmd.com/read/29024987/development-and-validation-of-an-eight-item-brief-form-of-the-soapp-r-soapp-8
#17
Ryan A Black, Stacey A McCaffrey, Albert J Villapiano, Robert N Jamison, Stephen F Butler
Objective: Although the Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) has become a widely used screener for aberrant opioid-related behavior in adults, the length of the instrument may limit its utility. The purpose of the current study was to develop a short form of the SOAPP-R by retaining as few items as possible while maximizing predictive accuracy. Methods: Participants (N = 555), recruited from pain clinics, completed the 24-item SOAPP-R and participated in a five-month follow-up visit to evaluate aberrant drug-related behaviors...
August 11, 2017: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/29021709/subacute-oral-toxicity-and-bacterial-mutagenicity-study-of-korean-red-ginseng-oil
#18
Hwi Won Seo, Jae Hyun Suh, Seung-Ho So, Jong-Soo Kyung, Yong-Soon Kim, Chang-Kyun Han
BACKGROUND: Red ginseng oil (RGO) is produced by supercritical CO2 extraction of secondary products derived from Korean Red Ginseng extract. As the use of RGO has increased, product safety concerns have become more important. METHODS: In the present study, the subacute oral toxicity and bacterial reverse mutagenicity of RGO were evaluated. Sprague-Dawley rats were orally administered with RGO for 28 d by gavage. Daily RGO dose concentrations were 0 mg/kg body weight (bw), 500 mg/kg bw, 1,000 mg/kg bw, or 2,000 mg/kg bw per day...
October 2017: Journal of Ginseng Research
https://www.readbyqxmd.com/read/28994525/-discussion-on-efficacy-evaluation-thought-and-method-for-innovation-medicine-of-chinese-herbal-compound-formula-based-on-clinical-application-characteristics
#19
Jian-Ning Sun, Wen-Yan Sun, Shi-Fen Dong
The Chinese herbal compound formula preparation was made based on theory of Chinese medicine, which was confirmed by long period clinical application, and with multi-compound and multi-target characteristics. During the exploitation process of innovation medicine of Chinese herbal compound formula, selecting and speeding up the research development of drugs with clinical value shall be paid more attention, and as request of rules involved in new drug research and development, the whole process management should be carried out, including project evaluation, manufacturing process determination, establishment of quality control standards, evaluation for pharmacological and toxic effect, as well as new drug application process...
March 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/28994213/a-novel-and-innovative-hair-test-to-determine-glucocorticoid-levels-in-racing-camels-for-use-in-assessment-of-doping-health-and-disease
#20
Iltaf Shah, Jody D Haddow, Hiba A Ibrahim, Maryam V A Sheikh, Fatima S A Alhemeiri
BACKGROUND: The aim of this project was to develop and validate a new test for the analysis of glucocorticoids in camel hair and to use the new test to analyse hair samples from a variety of camel breeds in sports and racing applications. These findings could be of importance when evaluating racing camels for suspected doping offenses or for injury and disease control. METHODS: Camel hair samples were collected from 30 non-racing dromedary camels along with 3 racing camels in Al Ain, UAE and were decontaminated, pulverized, sonicated and extracted prior to analysis...
October 9, 2017: Drug Testing and Analysis
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