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https://www.readbyqxmd.com/read/28432051/impact-of-study-outcome-on-submission-and-acceptance-metrics-for-peer-reviewed-medical-journals-six-year-retrospective-review-of-all-completed-glaxosmithkline-human-drug-research-studies
#1
Gary Evoniuk, Bernadette Mansi, Barbara DeCastro, Jennie Sykes
Objectives To determine whether the outcome of drug studies influenced submission and/or acceptance rates for publication in peer reviewed medical journals.Design A six year retrospective review of publication status by study outcome for all human drug research studies conducted by a single industry sponsor (GlaxoSmithKline) that completed from 1 January 2009 to 30 June 2014 and were therefore due for manuscript submission (per the sponsor's policy) to peer reviewed journals within 18 months of study completion-that is, 31 December 2015...
April 21, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28432048/solithromycin-a-novel-ketolide-antibiotic
#2
Michael J Buege, Jack E Brown, Samuel L Aitken
PURPOSE: The pharmacology, pharmacokinetics, pharmacodynamics, antimicrobial activity, clinical safety, and current regulatory status of solithromycin are reviewed. SUMMARY: Solithromycin is a novel ketolide antibiotic developed for the treatment of community-acquired bacterial pneumonia (CABP). Its pharmacologic, pharmacokinetic, and pharmacodynamic properties provide activity against a broad range of intracellular organisms, including retained activity against pathogens displaying various mechanisms of macrolide resistance...
April 21, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28431310/characterization-of-bacterial-communities-of-donkey-milk-by-high-throughput-sequencing
#3
Maria de Los Dolores Soto Del Rio, Alessandra Dalmasso, Tiziana Civera, Maria Teresa Bottero
The interest in donkey milk (DM) is growing because of its functional properties and nutritional value, especially for children with allergies and food intolerances. However, most of the available reports of DM microbiota are based on culture-dependent methods to investigate food safety issues and the presence of lactic acid bacteria (LAB). The aim of this study was to determine the composition of DM bacterial communities using a high-throughput sequencing (HTS) approach. Bulk milk samples from Italian donkey dairy farms from two consecutive years were analysed using the MiSeq Illumina platform...
March 30, 2017: International Journal of Food Microbiology
https://www.readbyqxmd.com/read/28430558/lower-esophageal-sphincter-augmentation-for-gastroesophageal-reflux-disease-the-safety-of-a-modern-implant
#4
C Daniel Smith, Robert A Ganz, John C Lipham, Reginald C Bell, David W Rattner
INTRODUCTION: Use of the magnetic sphincter augmentation device (MSAD) for gastroesophageal reflux disease (GERD) is increasing. As this innovative treatment for GERD gains widespread use and adoption, an assessment of its safety since U.S. market introduction is presented. METHODS: Events were collected from the Manufacturer and User Facility Device Experience (MAUDE) database, which reports events submitted to the Food and Drug Administration (FDA) of suspected device-associated deaths, serious injuries, and malfunctions...
April 21, 2017: Journal of Laparoendoscopic & Advanced Surgical Techniques. Part A
https://www.readbyqxmd.com/read/28430022/safety-by-design-of-printed-multilayer-materials-intended-for-food-packaging
#5
Celia Domeño, Margarita Aznar, Cristina Nerín, Francesca Isella, Mauro Fedeli, Osvaldo Bosetti
Printing inks are commonly used in multilayer plastics materials used for food packaging and compounds present in inks can migrate to the food either by diffusion through the multilayers or because of set-off phenomena. To avoid this problem the right design of the packaging is crucial. In this work, the safety by design of multilayer materials has been studied. First, the migration from 4 different multilayers manufactured using polyethylene terephthalate (PET), aluminium (Al) and polyethylene (PE) was determined...
April 21, 2017: Food Additives & Contaminants. Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment
https://www.readbyqxmd.com/read/28429307/emerging-approaches-to-food-desensitization-in-children
#6
REVIEW
Ahmad Hamad, Wesley A Burks
PURPOSE OF REVIEW: The purpose of this review is to highlight the recent advances in food desensitization in children with food allergy. RECENT FINDINGS: Recent advancements in epicutaneous, sublingual, and oral immunotherapy for food allergy in the future may offer children with food allergy and their families a viable option to reduce risk or severity of anaphylaxis with phase III trials ongoing for two of these treatment modalities. Food allergy prevalence in children is estimated to be up to 8%...
May 2017: Current Allergy and Asthma Reports
https://www.readbyqxmd.com/read/28428778/evidence-for-nitric-oxide-synthase-activity-in-staphylococcus-xylosus-mediating-nitrosoheme-formation
#7
Geoffrey Ras, Véronique Zuliani, Patrick Derkx, Tim M Seibert, Sabine Leroy, Régine Talon
Staphylococcus xylosus is used as a starter culture in fermented meat products and contributes to color formation by the reduction of nitrate to nitrite. Nitrite is a food additive that is chemically turned to nitric oxide (NO) in meat but its safety has been questioned. The objective of this study was to determine the ability of NO synthase (NOS) of S. xylosus C2a to produce NO. For this purpose, a nos deletion mutant (Δnos) in S. xylosus was constructed and NO production was evaluated in a test based on its ability to form nitrosomyoglobin and nitrosoheme...
2017: Frontiers in Microbiology
https://www.readbyqxmd.com/read/28428292/shigella-draft-genome-sequences-resources-for-food-safety-and-public-health
#8
Allison M Weis, Brent Gilpin, Bihua C Huang, Nguyet Kong, Poyin Chen, Bart C Weimer
Shigella is a major foodborne pathogen that infects humans and nonhuman primates and is the major cause of dysentery and reactive arthritis worldwide. This is the initial public release of 16 Shigella genome sequences from four species sequenced as part of the 100K Pathogen Genome Project.
April 20, 2017: Genome Announcements
https://www.readbyqxmd.com/read/28427828/a-combined-clostridium-perfringens-trueperella-pyogenes-inactivated-vaccine-induces-complete-immunoprotection-in-a-mouse-model
#9
Wenlong Zhang, Pu Wang, Bing Wang, Bo Ma, Junwei Wang
Clostridium perfringens (C. perfringens) and Trueperella pyogenes (T. pyogenes) are two bacterial pathogens frequently associated with wound infections and following lethal complications in livestock. However, prudent use of antimicrobial agents is highly required given the emergence of multidrug-resistant strains of both bacteria and need for food safety. In the current study, a combined vaccine, composed of inactivated C. perfringens and T. pyogenes, was prepared. The amount of formaldehyde being used to inactivate two bacteria was optimized to retain the immunogenicity of antigens...
April 17, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28427537/metabolomics-nutrition-and-potential-biomarkers-of-food-quality-intake-and-health-status
#10
Jean-Louis Sébédio
Diet, dietary patterns, and other environmental factors such as exposure to toxins are playing an important role in the prevention/development of many diseases, like obesity, type 2 diabetes, and consequently on the health status of individuals. A major challenge nowadays is to identify novel biomarkers to detect as early as possible metabolic dysfunction and to predict evolution of health status in order to refine nutritional advices to specific population groups. Omics technologies such as genomics, transcriptomics, proteomics, and metabolomics coupled with statistical and bioinformatics tools have already shown great potential in this research field even if so far only few biomarkers have been validated...
2017: Advances in Food and Nutrition Research
https://www.readbyqxmd.com/read/28427534/methodologies-for-the-characterization-of-the-quality-of-dairy-products
#11
Romdhane Karoui
The growing interest of consumers in food quality and safety issues has contributed to the increasing demand for sensitive and rapid analytical technologies. Physicochemical, textural, sensory, etc., methods have been used to evaluate the quality and authenticity of milk and dairy products. Despite the importance of these standard methods, they are expensive and time consuming. Recently, spectroscopic methods have shown great potential due to speed of analysis, minimal sample preparation, high repeatability, low cost, and, most of all, the fact that these techniques are noninvasive and nondestructive and, therefore, could be applied to any on-line monitoring system...
2017: Advances in Food and Nutrition Research
https://www.readbyqxmd.com/read/28427104/pharmacokinetics-and-pharmacodynamics-of-tofogliflozin-a-selective-sglt2-inhibitor-in-healthy-male-subjects
#12
Nahoko Kasahara-Ito, Hiroyuki Fukase, Yoichiro Ogama, Tomohisa Saito, Yasuhiro Ohba, Sumire Shimada, Yasuki Takano, Tomoko Ichihara, Kimio Terao, Noboru Nakamichi, Yuji Kumagai, Sachiya Ikeda
Tofogliflozin is a selective oral inhibitor of sodium-glucose co-transporter 2 for treatment of type 2 diabetes mellitus. The pharmacokinetics, pharmacodynamics, and safety of tofogliflozin were investigated in healthy male subjects. Three studies were conducted: single-ascending dose study (10-640 mg) in 56 Japanese and 24 Caucasian subjects; multiple-ascending dose study (2.5-80 mg once daily for 7 days) in 24 Japanese subjects; and food-effect study (20-40 mg) in 30 Japanese subjects. Tofogliflozin was absorbed rapidly and eliminated from the systemic circulation with a t1/2 of 5-6 h...
April 20, 2017: Drug Research
https://www.readbyqxmd.com/read/28425902/evidence-for-the-benefits-of-food-chain-interventions-on-e-coli-0157-h7-nm-prevalence-in-retail-ground-beef-and-human-disease-incidence-a-success-story
#13
Frank Pollari, Tanya Christidis, Katarina D M Pintar, Andrea Nesbitt, Jeff Farber, Marie-Claude Lavoie, Alex Gill, Penelope Kirsch, Roger P Johnson
OBJECTIVES: Human infection with Escherichia coli O157:H7/NM has historically been associated with consumption of undercooked ground beef. The purpose of this paper is to investigate the correlation of the decline in E. coli O157:H7/NM infections in Canada with the introduction of control efforts in ground beef by industry. METHODS: The human incidence of E. coli O157:H7/NM, prevalence in ground beef and interventions from 1996 to 2014 were analyzed. Pathogen prevalence data were obtained from federal government and industry surveillance and inspection/compliance programs...
April 20, 2017: Canadian Journal of Public Health. Revue Canadienne de Santé Publique
https://www.readbyqxmd.com/read/28424675/safety-protective-immunity-and-diva-capability-of-a-rough-mutant-salmonella-pullorum-vaccine-candidate-in-broilers
#14
Rongxian Guo, Yang Jiao, Zhuoyang Li, Shanshan Zhu, Xiao Fei, Shizhong Geng, Zhiming Pan, Xiang Chen, Qiuchun Li, Xinan Jiao
Salmonella enterica subsp. enterica serovar Gallinarum biovar Pullorum (Salmonella Pullorum) is highly adapted to chickens causing an acute systemic disease that results in high mortality. Vaccination represents one approach for promoting animal health, food safety and reducing environmental persistence in Salmonella control. An important consideration is that Salmonella vaccination in poultry should not interfere with the salmonellosis monitoring program. This is the basis of the DIVA (Differentiation of Infected and Vaccinated Animals) program...
2017: Frontiers in Microbiology
https://www.readbyqxmd.com/read/28424323/dosing-three-drug-combinations-that-include-targeted-anti-cancer-agents-analysis-of-37-763-patients
#15
Mina Nikanjam, Sariah Liu, Jincheng Yang, Razelle Kurzrock
BACKGROUND: Combining targeted and cytotoxic agents has the potential to improve efficacy and attenuate resistance for metastatic cancer. Information regarding safe starting doses for clinical trials of novel three-drug combinations is lacking. MATERIALS AND METHODS: Published phase I-III adult oncology clinical trials of three-drug combinations involving a targeted agent were identified by PubMed search (January 1, 2010 to December 31, 2013). A dose percentage was calculated to compare the dose used in combination to the single agent recommended dose: (U...
April 19, 2017: Oncologist
https://www.readbyqxmd.com/read/28421428/how-has-cder-prepared-for-the-nano-revolution-a-review-of-risk-assessment-regulatory-research-and-guidance-activities
#16
Katherine M Tyner, Nan Zheng, Stephanie Choi, Xiaoming Xu, Peng Zou, Wenlei Jiang, Changning Guo, Celia N Cruz
The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration (FDA) was established to assess the potential impact of nanotechnology on drug products. One of the working group's major initiatives has been to conduct a comprehensive risk management exercise regarding the potential impact of nanomaterial pharmaceutical ingredients and excipients on drug product quality, safety, and efficacy. This exercise concluded that current review practices and regulatory guidance are capable of detecting and managing the potential risks to quality, safety, and efficacy when a drug product incorporates a nanomaterial...
April 18, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28421100/integrated-approach-of-agri-nanotechnology-challenges-and-future-trends
#17
REVIEW
Sandhya Mishra, Chetan Keswani, P C Abhilash, Leonardo F Fraceto, Harikesh Bahadur Singh
Nanotechnology representing a new frontier in modern agriculture is anticipated to become a major thrust in near future by offering potential applications. This integrating approach, i.e., agri-nanotechnology has great potential to cope with global challenges of food production/security, sustainability and climate change. However, despite the potential benefits of nanotechnology in agriculture so far, their relevance has not reached up to the field conditions. The elevating concerns about fate, transport, bioavailability, nanoparticles toxicity and inappropriateness of regulatory framework limit the complete acceptance and inclination to adopt nanotechnologies in agricultural sector...
2017: Frontiers in Plant Science
https://www.readbyqxmd.com/read/28421074/immunometabolic-phenotype-alterations-associated-with-the-induction-of-disease-tolerance-and-persistent-asymptomatic-infection-of-salmonella-in-the-chicken-intestine
#18
REVIEW
Michael H Kogut, Ryan J Arsenault
The adaptation of Salmonella enterica to the eukaryotic host is a key process that enables the bacterium to survive in a hostile environment. Salmonella have evolved an intimate relationship with its host that extends to their cellular and molecular levels. Colonization, invasion, and replication of the bacteria in an appropriate host suggest that modification of host functions is central to pathogenesis. Intuitively, this subversion of the cell must be a complex process, since hosts are not inherently programmed to provide an environment conducive to pathogens...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/28421064/current-perspectives-on-viable-but-non-culturable-state-in-foodborne-pathogens
#19
REVIEW
Xihong Zhao, Junliang Zhong, Caijiao Wei, Chii-Wann Lin, Tian Ding
The viable but non-culturable (VBNC) state, a unique state in which a number of bacteria respond to adverse circumstances, was first discovered in 1982. Unfortunately, it has been reported that many foodborne pathogens can be induced to enter the VBNC state by the limiting environmental conditions during food processing and preservation, such as extreme temperatures, drying, irradiation, pulsed electric field, and high pressure stress, as well as the addition of preservatives and disinfectants. After entering the VBNC state, foodborne pathogens will introduce a serious crisis to food safety and public health because they cannot be detected using conventional plate counting techniques...
2017: Frontiers in Microbiology
https://www.readbyqxmd.com/read/28421047/genetic-characterization-of-the-exceptionally-high-heat-resistance-of-the-non-toxic-surrogate-clostridium-sporogenes-pa-3679
#20
Robert R Butler, Kristin M Schill, Yun Wang, Jean-François Pombert
Clostridium sporogenes PA 3679 is a non-toxic endospore former that is widely used as a surrogate for Clostridium botulinum by the food processing industry to validate thermal processing strategies. PA 3679 produces spores of exceptionally high heat resistance without botulinum neurotoxins, permitting the use of PA 3679 in inoculated pack studies while ensuring the safety of food processing facilities. To identify genes associated with this heat resistance, the genomes of C. sporogenes PA 3679 isolates were compared to several other C...
2017: Frontiers in Microbiology
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