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https://www.readbyqxmd.com/read/28346203/u-s-food-and-drug-administration-inspections-guide-to-a-successful-outcome-for-503a-sterile-compounding-pharmacies
#1
Doug Yoch
The reasons for which pharmaceutical compounding is the focus of intense state and federal scrutiny are now well known. Compounders are faced with an ever-increasing need to prove, by objective standards, the safety, purity, and potency of the formulations they dispense. They must also demonstrate their compliance with regulations often based on current good compounding practices designed for the pharmaceutical industry. In the U.S. today, rigorous unannounced state and federal inspections of compounding facilities are occurring more and more frequently...
March 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28345184/spatial-molecular-epidemiology-of-carbapenem-resistant-and-new-delhi-metallo-beta-lactamase-blandm-producing-escherichia-coli-strains-from-farmed-piglets-of-india
#2
B S Pruthvishree, O R Vinodh Kumar, D K Sinha, Y P S Malik, Z Dubal, P A Desingu, M Shivakumar, Narayanan Krishnaswamy, B R Singh
AIM: A cross-sectional study was conducted in ten government organized pig farms between 2014 and 2016 representing seven states of India to understand the epidemiology of carbapenem resistance in Escherichia coli isolates. METHODS AND RESULTS: In this study, 673 fecal samples both from non- diarhhoeic (n=501) and diarrhoeic (n=172) piglets were processed for isolation of carbapenem resistant E. coli. Wherein, 112 confirmed E. coli isolates were further subjected for genotypic confirmation of carbapenem resistance and virulence factors...
March 27, 2017: Journal of Applied Microbiology
https://www.readbyqxmd.com/read/28343413/development-and-implementation
#3
Teresa Schwendler, Cara Shipley, Nadine Budd, Angela Trude, Pamela J Surkan, Elizabeth Anderson Steeves, Priscila de Morais Sato, Thomas Eckmann, Hong Loh, Joel Gittelsohn
Higher rates of obesity and obesity-related chronic disease are prevalent in communities where there is limited access to affordable, healthy food. The B'More Healthy Communities for Kids (BHCK) trial worked at multiple levels of the food environment including food wholesalers and corner stores to improve the surrounding community's access to healthy food. The objective of this article is to describe the development and implementation of BHCK's corner store and wholesaler interventions through formal process evaluation...
March 1, 2017: Health Promotion Practice
https://www.readbyqxmd.com/read/28342160/dogs-demonstrate-perspective-taking-based-on-geometrical-gaze-following-in-a-guesser-knower-task
#4
Amélie Catala, Britta Mang, Lisa Wallis, Ludwig Huber
Currently, there is still no consensus about whether animals can ascribe mental states (Theory of Mind) to themselves and others. Showing animals can respond to cues that indicate whether another has visual access to a target or not, and that they are able to use this information as a basis for whom to rely on as an informant, is an important step forward in this direction. Domestic dogs (Canis familiaris) with human informants are an ideal model, because they show high sensitivity towards human eye contact, they have proven able to assess the attentional state of humans in food-stealing or food-begging contexts, and they follow human gaze behind a barrier when searching for food...
March 24, 2017: Animal Cognition
https://www.readbyqxmd.com/read/28339805/design-and-evaluation-of-a-pharmacogenomics-information-resource-for-pharmacists
#5
Katrina M Romagnoli, Richard D Boyce, Philip E Empey, Yifan Ning, Solomon Adams, Harry Hochheiser
Objective: To develop and evaluate a pharmacogenomics information resource for pharmacists. Materials and Methods: We built a pharmacogenomics information resource presenting Food and Drug Administration (FDA) drug product labelling information, refined it based on feedback from pharmacists, and conducted a comparative usability evaluation, measuring task completion time, task correctness and perceived usability. Tasks involved hypothetical clinical situations requiring interpretation of pharmacogenomics information to determine optimal prescribing for specific patients...
February 26, 2017: Journal of the American Medical Informatics Association: JAMIA
https://www.readbyqxmd.com/read/28339677/development-of-a-food-allergy-knowledge-test-for-parents
#6
Amy L Hahn, Lynnda M Dahlquist, Jessica L Hoehn, Mary Elizabeth Bollinger
Objective : To create a measure of food allergy (FA) knowledge for parents of children with FA. The food allergy knowledge test (FAKT) was developed following rigorous test-construction guidelines. The preliminary 110-item pool content was developed in consultation with FA experts. After cognitive interviews and revisions, an 88-item preliminary version was administered to 370 parents of children with FA who were recruited online and from an allergy clinic. After item difficulty, discrimination, item-scale correlations analyses, and assessment of internal consistency, a revised 57-item version was administered to a new clinic-based sample (77 parents)...
February 19, 2017: Journal of Pediatric Psychology
https://www.readbyqxmd.com/read/28337180/the-effect-of-increased-loads-of-dissolved-organic-matter-on-estuarine-microbial-community-composition-and-function
#7
Sachia J Traving, Owen Rowe, Nina M Jakobsen, Helle Sørensen, Julie Dinasquet, Colin A Stedmon, Agneta Andersson, Lasse Riemann
Increased river loads are projected as one of the major consequences of climate change in the northern hemisphere, leading to elevated inputs of riverine dissolved organic matter (DOM) and inorganic nutrients to coastal ecosystems. The objective of this study was to investigate the effects of elevated DOM on a coastal pelagic food web from the coastal northern Baltic Sea, in a 32-day mesocosm experiment. In particular, the study addresses the response of bacterioplankton to differences in character and composition of supplied DOM...
2017: Frontiers in Microbiology
https://www.readbyqxmd.com/read/28336789/percutaneous-therapy-for-tricuspid-regurgitation-a-new-frontier-for-interventional-cardiology
#8
Samir R Kapadia, Amar Krishnaswamy, E Murat Tuzcu
Functional tricuspid regurgitation (FTR) is common, whether in association with mitral or aortic valve disease or presenting as an isolated valvular disease. Several studies have shown that TR is associated with poor patient outcomes, though a cause-and-effect relationship of TR to mortality has not been proven. Similarly the impact of surgical treatment of TR on outcomes needs well-controlled randomized trials that are under planning. The current professional society guidelines for treatment of TR are based on expert opinions with a level of evidence C for all indications...
March 23, 2017: Circulation
https://www.readbyqxmd.com/read/28336352/accessibility-and-affordability-of-supermarkets-associations-with-the-dash-diet
#9
Joreintje D Mackenbach, Thomas Burgoine, Jeroen Lakerveld, Nita G Forouhi, Simon J Griffin, Nicholas J Wareham, Pablo Monsivais
INTRODUCTION: It is unknown whether there is an interplay of affordability (economic accessibility) and proximity (geographic accessibility) of supermarkets in relation to having a Dietary Approaches to Stop Hypertension (DASH)-accordant diet. METHODS: Data (collected: 2005-2015, analyzed: 2016) were from the cross-sectional, population-based Fenland Study cohort: 9,274 adults aged 29-64 years, living in Cambridgeshire, United Kingdom. Dietary quality was evaluated using an index of DASH dietary accordance, based on recorded consumption of foods and beverages in a validated 130-item, semi-quantitative food frequency questionnaire...
March 20, 2017: American Journal of Preventive Medicine
https://www.readbyqxmd.com/read/28334294/an-examination-of-the-role-of-l-glutamate-and-inosine-5-monophosphate-in-hedonic-taste-guided-behavior-by-mice-lacking-the-t1r1-t1r3-receptor
#10
Ginger D Blonde, Alan C Spector
The heterodimeric T1R1 + T1R3 receptor is considered critical for normal signaling of L-glutamate and 5'-ribonucleotides in the oral cavity. However, some taste-guided responsiveness remains in mice lacking one subunit of the receptor, suggesting that other receptors are sufficient to support some behaviors. Here, mice lacking both receptor subunits (KO) and wild-type (WT, both n = 13) mice were tested in a battery of behavioral tests. Mice were trained and tested in gustometers with a concentration series of Maltrin-580, a maltodextrin, in a brief-access test (10-s trials) as a positive control...
March 17, 2017: Chemical Senses
https://www.readbyqxmd.com/read/28333235/ovarian-hormones-and-obesity
#11
Brigitte Leeners, Nori Geary, Philippe N Tobler, Lori Asarian
BACKGROUND: Obesity is caused by an imbalance between energy intake, i.e. eating and energy expenditure (EE). Severe obesity is more prevalent in women than men worldwide, and obesity pathophysiology and the resultant obesity-related disease risks differ in women and men. The underlying mechanisms are largely unknown. Pre-clinical and clinical research indicate that ovarian hormones may play a major role. OBJECTIVE AND RATIONALE: We systematically reviewed the clinical and pre-clinical literature on the effects of ovarian hormones on the physiology of adipose tissue (AT) and the regulation of AT mass by energy intake and EE...
March 2, 2017: Human Reproduction Update
https://www.readbyqxmd.com/read/28332567/dairy-cows-value-access-to-pasture-as-highly-as-fresh-feed
#12
Marina A G von Keyserlingk, Andressa Amorim Cestari, Becca Franks, Jose A Fregonesi, Daniel M Weary
Many dairy cows in the developed world are now housed exclusively indoors with fewer than 5% of the 10 million lactating cows in the United States having access to pasture during the grazing season. Indoor housing systems are designed to meet biological needs for food, water, hygiene, and shelter, but surveys of public and farmer opinion suggest that people think that pasture access is also important for the well-being of dairy cows. To determine if pasture access is important to the cows themselves, we investigated to what extent cows will work to access pasture (by pushing on a weighted gate), and compared it to the motivation to access fresh feed...
March 23, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28330733/what-do-children-eat-in-the-summer-a-direct-observation-of-summer-day-camps-that-serve-meals
#13
Erica L Kenney, Rebekka M Lee, Carolyn J Brooks, Angie L Cradock, Steven L Gortmaker
BACKGROUND: More than 14 million children in the United States attend summer camp annually, yet little is known about the food environment in day camps. OBJECTIVE: Our aim was to describe the nutritional quality of meals served to, brought by, and consumed by children attending summer day camps serving meals and snacks, and to describe camp water access. DESIGN: We conducted a cross-sectional study. PARTICIPANTS/SETTINGS: Participants were 149 children attending five summer camps in Boston, MA, in 2013...
March 16, 2017: Journal of the Academy of Nutrition and Dietetics
https://www.readbyqxmd.com/read/28330134/phytases-from-enterobacter-and-serratia-species-with-desirable-characteristics-for-food-and-feed-applications
#14
Harpreet Kaur Kalsi, Rajveer Singh, Harcharan Singh Dhaliwal, Vinod Kumar
Phytases are enzymes of great industrial importance with wide range of applications in animal and human nutrition. These catalyze the hydrolysis of phosphomonoester bonds in phytate, thereby releasing lower forms of myo-inositol phosphates and inorganic phosphate. Addition of phytase to plant-based foods can improve its nutritional value and increase mineral bioavailability by decreasing nutritional effect of phytate. In the present investigation, 43 phytase positive bacteria on PSM plates were isolated from different sources and characterized for phytase activity...
June 2016: 3 Biotech
https://www.readbyqxmd.com/read/28328015/pcsk9-inhibitor-access-barriers-issues-and-recommendations-improving-the-access-process-for-patients-clinicians-and-payers
#15
REVIEW
Seth J Baum, Peter P Toth, James A Underberg, Paul Jellinger, Joyce Ross, Katherine Wilemon
The proprotein convertase subtilisin/kexin type 9 inhibitors or monoclonal antibodies likely represent the greatest advance in lipid management in 30 years. In 2015 the US Food and Drug Administration approved both alirocumab and evolocumab for high-risk patients with familial hypercholesterolemia (FH) and clinical atherosclerotic cardiovascular disease requiring additional lowering of low-density lipoprotein cholesterol. Though many lipid specialists, cardiovascular disease prevention experts, endocrinologists, and others prescribed the drugs on label, they found their directives denied 80% to 90% of the time...
March 22, 2017: Clinical Cardiology
https://www.readbyqxmd.com/read/28326539/isotopic-niche-partitioning-between-two-apex-predators-over-time
#16
M Drago, L Cardona, V Franco-Trecu, E A Crespo, D Vales, F Borella, L Zenteno, E M Gonzáles, P Inchausti
1.Stable isotope analyses have become an important tool in reconstructing diets, analyzing resource use patterns, elucidating trophic relations among predators and understanding the structure of food webs. 2.Here, we use stable carbon and nitrogen isotope ratios in bone collagen to reconstruct and compare the isotopic niches of adult South American fur seals (Arctocephalus australis; n = 86) and sea lions (Otaria flavescens; n = 49) -two otariid species with marked morphological differences- in the Río de la Plata estuary (Argentina - Uruguay) and the adjacent Atlantic Ocean during the second half of the 20(th) century and the beginning of the 21(st) century...
March 22, 2017: Journal of Animal Ecology
https://www.readbyqxmd.com/read/28325973/building-a-database-for-long-term-monitoring-of-benthic-macrofauna-in-the-pertuis-charentais-2004-2014
#17
Anne S Philippe, Christine Plumejeaud-Perreau, Jérôme Jourde, Philippe Pineau, Nicolas Lachaussée, Emmanuel Joyeux, Frédéric Corre, Philippe Delaporte, Pierrick Bocher
BACKGROUND: Long-term benthic monitoring is rewarding in terms of science, but labour-intensive, whether in the field, the laboratory, or behind the computer. Building and managing databases require multiple skills, including consistency over time as well as organisation via a systematic approach. Here, we introduce and share our spatially explicit benthic database, comprising 11 years of benthic data. It is the result of intensive benthic sampling that has been conducted on a regular grid (259 stations) covering the intertidal mudflats of the Pertuis-Charentais (Marennes-Oléron Bay and Aiguillon Bay)...
2017: Biodiversity Data Journal
https://www.readbyqxmd.com/read/28325944/synergistic-antibacterial-mechanism-of-the-lactobacillus-crispatus-surface-layer-protein-and-nisin-on-staphylococcus-saprophyticus
#18
Zhilan Sun, Pengpeng Li, Fang Liu, Huan Bian, Daoying Wang, Xiaomeng Wang, Ye Zou, Chong Sun, Weimin Xu
SlpB, a surface layer protein isolated from Lactobacillus crispatus, has the potential to enhance the antimicrobial activity of nisin. Previous research indicated that, when combined with nisin, SlpB acted synergistically to inhibit Staphylococcus saprophyticus growth, thus extending the shelf life of chicken meat. In order to understand how SlpB enhances the antibacterial activity of nisin, electron microscopy, confocal laser scanning microscopy, flow cytometry and transmembrane electrical potential analysis were used to study cell wall organization and cell membrane integrity...
March 21, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28323074/an-obesogenic-refined-low-fat-diet-disrupts-attentional-and-behavioral-control-processes-in-a-vigilance-task-in-rats
#19
Aaron P Blaisdell, Traci Biedermann, Eric Sosa, Ava Abuchaei, Neveen Youssef, Sylvie Bradesi
Diets consisting of refined foods (REF) are associated with poor physical (e.g., obesity and diabetes) and mental (e.g., depression) health and impaired cognition. Few animal studies have explored the causal links between diet processing and health. Instead, most studies focus on the role of macronutrients, especially carbohydrate and fat concurrently with how processed are the ingredients. We previously showed that a REF low fat diet (LFD) caused greater adiposity and impaired motivation compared to an unrefined control (CON) diet consisting of similar macronutrient ratios (Blaisdell et al...
March 18, 2017: Behavioural Processes
https://www.readbyqxmd.com/read/28322236/the-role-of-mesolimbic-reward-neurocircuitry-in-prevention-and-rescue-of-the-activity-based-anorexia-aba-phenotype-in-rats
#20
Claire J Foldi, Laura K Milton, Brian J Oldfield
Patients suffering anorexia nervosa (AN) become anhedonic; unable or unwilling to derive normal pleasures and avoid rewarding outcomes, most profoundly in food intake. The activity-based anorexia (ABA) model recapitulates many of the characteristics of the human condition, including anhedonia, and allows investigation of the underlying neurobiology of AN. The potential for increased neuronal activity in reward/hedonic circuits to prevent and rescue weight loss is investigated in this model. The mesolimbic pathway extending from the ventral tegmental area (VTA) to the nucleus accumbens (NAc) was activated using a dual viral strategy, involving retrograde transport of Cre (CAV2-Cre) to the VTA and coincident injection of DREADD receptors (AAV-hSyn-DIO-hM3D(Gq)-mCherry)...
March 21, 2017: Neuropsychopharmacology: Official Publication of the American College of Neuropsychopharmacology
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