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https://www.readbyqxmd.com/read/28945018/-expert-consensus-on-the-design-and-implementation-of-clinical-safety-centralized-monitoring-study-of-chinese-medical-injection
#1
Jun-Hua Zhang, Jing-Tian Ren, Jing-Qing Hu, Yan-Ming Xie, Hai-Bo Song, Ming-Jun Zhu, Rui Gao, Zhong Wang, Wen-Ke Zheng, Xue-Lin Li, Meng Jiang, Yu-Hong Huang, Fang Lu, Li-Yun He, Wei-Xiong Lian, Zhong-Qi Yang, Wei-An Yuan, Si-Yuan Hu, Bao-He Wang, Wei-Liang Wang, De-Quan Ren, Bo-Li Zhang
Along with the increase of clinical application, the safety of traditional Chinese medicine gained more and more attentions. In particular, the safety evaluation of Chinese medical injections has become a mandatory task should be completed by pharmaceutical companies under the supervision of China Food and Drug Administration(CFDA). Due to the weak foundation of previous studies, the safety issues of Chinese medical injections have not been fully understood, and lack of scientific and rational risk management programs...
January 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/28943819/evaluation-of-safety-in-exceeding-maximum-adult-doses-of-commonly-used-second-generation-antiepileptic-drugs-in-pediatric-patients
#2
Mindl M Messinger, Sunita N Misra, Gary D Clark, Shannon M DiCarlo
OBJECTIVE: Pediatric patients often require larger doses of antiepileptic drug (AED) than adults in order to attain therapeutic serum concentrations and/or achieve seizure control. Safety and efficacy data are often extrapolated from adult literature; hence, optimal dosage may only be determined anecdotally or based on expert opinion. With limited pediatric dosing guidelines, milligrams per day that are based on weight may exceed the maximum adult dose. The primary objective of this study is to evaluate the safety of exceeding maximum doses as specified by the US Food and Drug Administration or manufacturers of commonly used AEDs in pediatric patients...
July 2017: Journal of Pediatric Pharmacology and Therapeutics: JPPT: the Official Journal of PPAG
https://www.readbyqxmd.com/read/28943771/microbial-risk-assessment-of-non-enterohemorrhagic-escherichia-coli-in-natural-and-processed-cheeses-in-korea
#3
Kyungmi Kim, Heeyoung Lee, Soomin Lee, Sejeong Kim, Jeeyeon Lee, Jimyeong Ha, Yohan Yoon
This study assessed the quantitative microbial risk of non-enterohemorrhagic Escherichia coli (EHEC). For hazard identification, hazards of non-EHEC E. coli in natural and processed cheeses were identified by research papers. Regarding exposure assessment, non-EHEC E. coli cell counts in cheese were enumerated, and the developed predictive models were used to describe the fates of non-EHEC E. coli strains in cheese during distribution and storage. In addition, data on the amounts and frequency of cheese consumption were collected from the research report of the Ministry of Food and Drug Safety...
2017: Korean Journal for Food Science of Animal Resources
https://www.readbyqxmd.com/read/28943112/update-on-food-safety-of-monosodium-l-glutamate-msg
#4
REVIEW
Helen Nonye Henry-Unaeze
OBJECTIVE: This evidence-based safety review of the flavor enhancer monosodium l-glutamate (MSG) was triggered by its global use and recent studies expressing some safety concerns. METHODOLOGY: This article obtained information through search of evidence-based scientific databases, especially the US National Library of Medicine NIH. RESULTS: (A) MSG is a water-soluble salt of glutamate, a non-essential amino acid, normally synthesized in the body and prevalent in protein foods...
September 18, 2017: Pathophysiology: the Official Journal of the International Society for Pathophysiology
https://www.readbyqxmd.com/read/28942719/can-ethanol-intoxication-secondary-to-docetaxel-be-predicted-based-on-dose-administered-using-a-point-of-care-saliva-ethanol-test
#5
Serena Cheng, Nadia I Awad, Kathleen C Toomey, Zinasia Gibson, Venai Chari, Luigi Brunetti
Background The Food and Drug Administration issued a drug safety alert highlighting the potential association of docetaxel infusion with signs and symptoms of alcohol intoxication. This concern is significant because patients treated with docetaxel often have comorbidities and are prescribed concomitant centrally active medications. As a result, these patients may be at risk for iatrogenic events. Objective The objective of this study was to identify a correlation with docetaxel infusion and saliva ethanol concentration using a point-of-care ethanol test...
January 1, 2017: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/28942074/immunosuppression-for-the-uveitides
#6
REVIEW
Douglas A Jabs
The uveitides are a collection of more than 30 diseases characterized by intraocular inflammation. Many cases of juvenile idiopathic arthritis-associated uveitis, many cases of intermediate uveitis, and most cases of posterior and panuveitides requiring treatment are treated with corticosteroids and immunosuppression. Disease-specific, time-updated modeling of clinical data for several uveitides suggests superior prevention of ocular complications and visual outcomes with immunosuppression. These studies also suggest that oral corticosteroids at doses low enough for safe long-term therapy (i...
September 20, 2017: Ophthalmology
https://www.readbyqxmd.com/read/28942030/toxicologic-evaluation-of-potassium-polyaspartate-a-5d-k-sd-genotoxicity-and-subchronic-toxicity
#7
C Galbusera, C Casalegno, S Marroncelli, G Triulzi, J Santos, E Corsini, P Restani
Potassium polyaspartate (A-5D K/SD) is proposed for use as a stabiliser in wine, with a maximum use level of 300 mg/L and typical levels in the range of 100-200 mg/L. Potassium polyaspartate (A-5D K/SD) tested negative in a bacterial reverse mutation assay performed in accordance with OECD TG 471 and in an in vitro mammalian cell micronucleus test performed in accordance with OECD TG 487. From a 90-day oral toxicity study in male and female Wistar rats performed in accordance with OECD TG 408, a no observed adverse effect level (NOAEL) was set at 1000 mg/kg bw per day, the highest dose tested...
September 20, 2017: Food and Chemical Toxicology
https://www.readbyqxmd.com/read/28941902/national-survey-of-foodborne-viruses-in-australian-oysters-at-production
#8
Valeria Torok, Kate Hodgson, Catherine McLeod, Jessica Tan, Navreet Malhi, Alison Turnbull
Internationally human enteric viruses, such as norovirus (NoV) and hepatitis A virus (HAV), are frequently associated with shellfish related foodborne disease outbreaks, and it has been suggested that acceptable NoV limits based on end-point testing be established for this high risk food group. Currently, shellfish safety is generally managed through the use of indicators of faecal contamination. Between July 2014 and August 2015, a national prevalence survey for NoV and HAV was done in Australian oysters suitable for harvest...
February 2018: Food Microbiology
https://www.readbyqxmd.com/read/28941900/model-for-listeria-monocytogenes-inactivation-by-high-hydrostatic-pressure-processing-in-spanish-chorizo-sausage
#9
Begoña Rubio, Arícia Possas, Francisco Rincón, Rosa María García-Gímeno, Beatríz Martínez
A central composite design was implemented to study the effect of three factors on HHP-induced L. monocytogenes inactivation in Spanish chorizo sausage, in order to increase its effectiveness: product aw (0.79-0.92), pressure intensities (349-600 MPa, at 18 °C) and holding time (0-12.53 min). Response surface methodology was implemented with backward stepwise regression to generate a model that best fitted to the experimental data. All the three factors studied significantly influenced HHP inactivation of L...
February 2018: Food Microbiology
https://www.readbyqxmd.com/read/28941196/pharmacokinetics-safety-and-tolerability-of-vortioxetine-following-single-and-multiple-dose-administration-in-healthy-japanese-adults
#10
Kumi Matsuno, Koki Nakamura, Yutaka Aritomi, Akira Nishimura
Three phase 1 randomized single-center studies assessed the pharmacokinetics, safety, and tolerability of vortioxetine after single- and multiple-dose administration in healthy Japanese adults. Study 1 assessed the pharmacokinetics of vortioxetine after administration of single rising doses to men and multiple doses to men and women; study 2 evaluated vortioxetine pharmacokinetics in elderly adults; and study 3 assessed food effects on vortioxetine pharmacokinetics in healthy men. The primary end points included pharmacokinetic parameters of vortioxetine and incidence of adverse events (AEs)...
September 21, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28940866/pharmacologically-controlled-drinking-in-the-treatment-of-alcohol-dependence-or-alcohol-use-disorders-a-systematic-review-with-direct-and-network-meta-analyses-on-nalmefene-naltrexone-acamprosate-baclofen-and-topiramate
#11
REVIEW
Clément Palpacuer, Renan Duprez, Alexandre Huneau, Clara Locher, Rémy Boussageon, Bruno Laviolle, Florian Naudet
BACKGROUND AND AIMS: Pharmacologically controlled drinking in the treatment of alcohol dependence or alcohol use disorders (AUDs) is an emerging concept. Our objective was to explore the comparative effectiveness of drugs used in this indication. DESIGN: Systematic review with direct and network meta-analysis of double-blind randomized controlled trials (RCTs) assessing the efficacy of nalmefene, naltrexone, acamprosate, baclofen or topiramate in non-abstinent adults diagnosed with alcohol dependence or AUDs...
September 20, 2017: Addiction
https://www.readbyqxmd.com/read/28940510/local-indigenous-fruit-derived-juices-as-alternate-source-of-acidity-regulators
#12
Cassandra D'souza, Rosaline Fernandes, Subhash Kudale, Azza Silotry Naik
BACKGROUND: Acidity regulators are additives that alter and control food acidity. The objective of this study was to explore local indigenous fruits as source of natural acidity regulators. Juices extracted from Garcinia indica (kokum), Embilica officinalis (amla) and Tamarindus indica (tamarind) were used as acidulants for medium such as coconut milk and bottle gourd juice. The buffering capacity (β), acid composition, antioxidant activity and shelf-life study of the acidified media were estimated...
September 20, 2017: Journal of the Science of Food and Agriculture
https://www.readbyqxmd.com/read/28940212/no-induced-mutagenesis-in-human-lymphoblast-cell-line-and-bacterial-systems-upon-their-prolonged-sub-culturing-in-irradiated-food-blended-media
#13
Sudhanshu Saxena, Sanjeev Kumar, Jyoti Tripathi, Satyendra Gautam
BACKGROUND: Confound apprehension towards safety of irradiated food has remained a major cause behind tardy acceptance of this technology though it has immense socio-economic potential. Generation of in depth scientific evidences will help to refute these apprehensions. With this prospective, present study was undertaken where safety of various irradiated (Dmin up to 25 kGy) foods was evaluated through long term exposure studies in models including human lymphoblast TK6 cell line (100 generations) and Escherichia coli MG1655 cells (exclusive subcuturing in irradiated food medium for 3000 generations)...
September 20, 2017: Journal of the Science of Food and Agriculture
https://www.readbyqxmd.com/read/28939340/use-of-ribosomal-proteins-as-biomarkers-for-identification-of-flavobacterium-psychrophilum-by-maldi-tof-mass-spectrometry
#14
Clara Fernández-Álvarez, Yolanda Torres-Corral, Ysabel Santos
Matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF-MS) is a rapid methodology for identification of bacteria that is increasingly used in diagnostic laboratories. This work aimed at evaluating the potential of MALDI-TOF-MS for identification of the main serotypes of Flavobacterium psychrophilum isolated from salmonids, and its discrimination from closely related Flavobacterium spp. A mass spectra library was constructed by analysing 70 F. psychrophilum strains representing the serotypes O1, O2a, O2b and O3, including reference and clinical isolates...
September 19, 2017: Journal of Proteomics
https://www.readbyqxmd.com/read/28938797/revisiting-the-safety-of-aspartame
#15
Arbind Kumar Choudhary, Etheresia Pretorius
Aspartame is a synthetic dipeptide artificial sweetener, frequently used in foods, medications, and beverages, notably carbonated and powdered soft drinks. Since 1981, when aspartame was first approved by the US Food and Drug Administration, researchers have debated both its recommended safe dosage (40 mg/kg/d) and its general safety to organ systems. This review examines papers published between 2000 and 2016 on both the safe dosage and higher-than-recommended dosages and presents a concise synthesis of current trends...
September 1, 2017: Nutrition Reviews
https://www.readbyqxmd.com/read/28938765/advanced-oxidation-process-sanitization-of-hatching-eggs-reduces-salmonella-in-broiler-chicks
#16
A C Rehkopf, J A Byrd, C D Coufal, T Duong
The microbial quality of eggs entering the hatchery is an important critical control point for biosecurity, pathogen reduction, and food safety programs in poultry production. Developing interventions to reduce Salmonella contamination of eggs is important to improving the microbial food safety of poultry and poultry products. The hydrogen peroxide (H2O2) and ultraviolet light (UV) Advanced Oxidation Process (AOP) has been previously demonstrated to be effective in reducing Salmonella on the surface of experimentally contaminated eggs...
October 1, 2017: Poultry Science
https://www.readbyqxmd.com/read/28937854/probiotics-from-isolation-to-application
#17
Parisa Shokryazdan, Mohammad Faseleh Jahromi, Juan Boo Liang, Yin Wan Ho
Probiotics have become highly recognized as supplements for humans and animals because of their beneficial effects on health and well-being. The present review aims to provide an overview of different steps through which microbial strains become applicable probiotics in food and/or feed industries. Isolation of potential probiotic strains is the first step. Lactic acid bacteria are the most frequently used microorganisms as probiotics, which can be isolated from human, animal, plant, and environment. The next steps are identification of the isolates and characterization of them based on the main selection criteria for any potential probiotic microorganism, including resistance to gastric acidity and bile salt, adherence to mucus and/or intestinal epithelial cells and cell lines, and antimicrobial and antagonism activity against potentially pathogenic microbes...
September 22, 2017: Journal of the American College of Nutrition
https://www.readbyqxmd.com/read/28935287/past-present-and-future-of-pharmacotherapy-for-obesity
#18
David Benaiges, Juan Pedro-Botet, Juana A Flores-Le Roux, Elisenda Climent, Albert Goday
Conventional treatment for obesity with diet, exercise and bariatric surgery has limitations; thus, it is necessary to have pharmacological tools. In the past, different drugs were marketed that were withdrawn due to safety problems. There are currently 3 drugs approved by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) for obesity therapy (orlistat, combination of bupropion and delayed-release naltrexone and liraglutide) and two more only authorized by FDA (lorcaserin and the combination of phentermine and extended release topiramate)...
September 18, 2017: Clínica e Investigación en Arteriosclerosis
https://www.readbyqxmd.com/read/28935212/the-value-of-anticoccidials-for-sustainable-global-poultry-production
#19
REVIEW
Stefanie Kadykalo, Tara Roberts, Michelle Thompson, Jeff Wilson, Marcelo Lang, Olivier Espeisse
Coccidiosis is a self-limiting disease that is universally present in poultry operations, causing extensive damage to the intestinal lining of the bird. Global economic losses from coccidiosis are estimated to be $3 billion per year. In-feed anticoccidial use has been the predominant form of coccidiosis control. However, due to widespread emergence of antimicrobial resistance, concerns have been raised regarding the safety of anticoccidials and potential impact on human, animal, and environmental health. To investigate the alternatives, risks, and benefits to anticoccidial use, a comprehensive review of recent literature was conducted...
September 18, 2017: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/28934240/microbial-characterization-of-bee-pollen-from-the-vesuvius-area-collected-by-using-three-different-traps
#20
Gianluigi Mauriello, Annachiara De Prisco, Gennaro Di Prisco, Antonietta La Storia, Emilio Caprio
Flower pollen is collected by honeybee foragers, adhered on their rear legs and transported into the hives in the form of pellets. Once in the hives, bee pollen is moisturised with nectar and bee mouth secretions and due to enzymatically modifications it becomes the so-called bee-bread, the protein reservoir of young bees. Bee pollen can be artificially removed from bee legs and collected by using specific systems, the bee pollen traps. Bee pollen is commercialized for human consumption as fresh product and after freezing or drying...
2017: PloS One
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