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https://www.readbyqxmd.com/read/28214915/evaluation-of-the-gard-assay-in-a-blind-cosmetics-europe-study
#1
Henrik Johansson, Robin Gradin, Andy Forreryd, Maria Agemark, Kathrin Zeller, Angelica Johansson, Olivia Larne, Erwin van Vliet, Carl Borrebaeck, Malin Lindstedt
Chemical hypersensitivity is an immunological response towards foreign substances, commonly referred to as sensitizers, which gives rise primarily to the clinical symptoms known as allergic contact dermatitis. For the purpose of mitigating risks associated with consumer products, chemicals are screened for sensitizing effects. Historically, such predictive screenings have been performed using animal models. However, due to industrial and regulatory demand, animal models for the purpose of sensitization assessment are being replaced by animal-free testing methods, a global trend that is spreading across industries and market segments...
February 17, 2017: ALTEX
https://www.readbyqxmd.com/read/28214791/a-need-to-stand-united-reply-to-the-wame-secretary
#2
John H Noble
I believe Dr Winker and I agree more than differ about the need for authors of medical journal reports of randomised controlled trial (RCT) findings to acknowledge when they make post hoc adjustments to the original content that they submit to obtain FDA marketing approval for a new drug or medical device.
February 13, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28214604/the-measurement-of-dlno-and-dlco-a-manufacturer-s-perspective
#3
X Giraud, N N Le-Dong, K Hogben, J B Martinot
The simultaneous measurement of the lung transfer factor for carbon monoxide (DLCO) and nitric oxide (DLNO) is now available as a powerful method for studying the alveolar-capillary gas exchange. However, application of the DLNO-CO technique in daily settings is still limited by some technical drawbacks. This paper provides a manufacturer's overview of the measuring principles, technical challenges and current available solutions for implementing the DLNO-CO measurement in to a marketed device. This includes the recent developments in technology for NO sensors, latest findings on NO uptake and new statistical methods...
February 15, 2017: Respiratory Physiology & Neurobiology
https://www.readbyqxmd.com/read/28213794/selected-cytokine-pathways-in-rheumatoid-arthritis
#4
REVIEW
Mélissa Noack, Pierre Miossec
Rheumatoid arthritis (RA) is a chronic inflammatory disease leading to joint destruction. Cytokines play a key role in its pathogenesis. They contribute to the induction and maintenance of inflammation and thus provide therapeutic targets. Many cytokines are involved in RA, and this review focuses on a few critical ones: tumor necrosis factor (TNF), interleukin (IL)-6, IL-1, IL-17, and GM-CSF. TNF and IL-6 are both well-established targets in RA treatment, and new biologic agents are reaching the market. IL-1 represents a more complex cytokine as results in humans do not reach those in animal models...
February 17, 2017: Seminars in Immunopathology
https://www.readbyqxmd.com/read/28213480/a-common-genetic-variant-risk-score-is-associated-with-drug-induced-qt-prolongation-and-torsade-de-pointes-risk-a-pilot-study
#5
David G Strauss, Jose Vicente, Lars Johannesen, Ksenia Blinova, Jay W Mason, Peter Weeke, Elijah R Behr, Dan M Roden, Raymond Woosley, Gulum Kosova, Michael A Rosenberg, Christopher Newton-Cheh
Background -Drug-induced QT interval prolongation, a risk factor for life-threatening ventricular arrhythmias, is a potential side effect of many marketed and withdrawn medications. The contribution of common genetic variants previously associated with baseline QT interval to drug-induced QT prolongation and arrhythmias is not known. Methods -We tested the hypothesis that a weighted combination of common genetic variants contributing to QT interval at baseline, identified through genome-wide association studies, can predict individual response to multiple QT-prolonging drugs...
February 17, 2017: Circulation
https://www.readbyqxmd.com/read/28213391/the-politics-and-policies-of-regulating-generics-in-latin-america-a-survey-of-seventeen-states
#6
Cassandra M Sweet
When patents expire, are equivalent generic alternatives available to citizens? This article contributes to current discussion on access to medicine in the aftermath of the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The focus is on off-patent or "generic" medicines: their product definitions, quality standards and prescription procedures. Drawing from a survey conducted of seventeen countries across the Latin American region, this article examines the differences in definition of off-patent products and the paradox of their relatively lower consumption across multiple developing states...
February 17, 2017: Journal of Health Politics, Policy and Law
https://www.readbyqxmd.com/read/28213092/prediction-of-thyroid-c-cell-carcinogenicity-after-chronic-administration-of-glp1-r-agonists-in-rodents
#7
Willem van den Brink, Annette Emerenciana, Francesco Bellanti, Oscar Della Pasqua, Jan Willem van der Laan
Increased incidence of C-cell carcinogenicity has been observed for glucagon-like-protein-1 receptor (GLP-1r) agonists in rodents. It is suggested that the duration of exposure is an indicator of carcinogenic potential in rodents of the different products on the market. Furthermore, the role of GLP-1-related mechanisms in the induction of C-cell carcinogenicity has gained increased attention by regulatory agencies. This study proposes an integrative pharmacokinetic/pharmacodynamic (PKPD) framework to identify explanatory factors and characterize differences in carcinogenic potential of the GLP-1r agonist products...
February 14, 2017: Toxicology and Applied Pharmacology
https://www.readbyqxmd.com/read/28213015/lettuce-and-fruits-as-a-source-of-multidrug-resistant-acinetobacter-spp
#8
Ana Carvalheira, Joana Silva, Paula Teixeira
The role of ready-to-eat products as a reservoir of pathogenic species of Acinetobacter remains unclear. The objective of the present study was to evaluate the presence of Acinetobacter species in lettuces and fruits marketed in Portugal, and their susceptibility to antimicrobials. Acinetobacter spp. were isolated from 77.9% of the samples and these microorganisms were also found as endophytes (i.e. present within the plant tissue) in 12 of 20 samples of lettuces analysed. Among 253 isolates that were identified as belonging to this genus, 181 presented different PFGE profiles, representing different strains...
June 2017: Food Microbiology
https://www.readbyqxmd.com/read/28212985/nonsteroidal-anti-inflammatory-drugs-in-clinical-and-experimental-epilepsy
#9
REVIEW
Beatrice Mihaela Radu, Florin Bogdan Epureanu, Mihai Radu, Paolo Francesco Fabene, Giuseppe Bertini
Current antiepileptic drugs have limited efficacy and provide little or no benefits in 30% of the patients. Given that a role for brain inflammation in epilepsy has been repeatedly reported in recent years, the potential of anti-inflammatory drugs should be explored in depth, as they may provide new therapeutical approaches in preventing or reducing epileptogenesis. Here, we review preclinical (both in vivo and in vitro) and clinical epilepsy studies in which nonsteroidal antiinflammatory drugs (NSAIDs), i...
February 9, 2017: Epilepsy Research
https://www.readbyqxmd.com/read/28212972/variation-in-health-technology-assessment-and-reimbursement-processes-in-europe
#10
Ronald L Akehurst, Eric Abadie, Noël Renaudin, François Sarkozy
BACKGROUND: It has been suggested that differences in health technology assessment (HTA) processes among countries, particularly within Europe, have led to inequity in patient access to new medicines. OBJECTIVES: To provide an up-to-date snapshot analysis of the present status of HTA and reimbursement systems in select European countries, and to investigate the implications of these processes, especially with regard to delays in market and patient access. METHODS: HTA and reimbursement processes were assessed through a review of published and gray literature, and through a series of interviews with HTA experts...
January 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28212952/the-challenge-of-conditional-reimbursement-stopping-reimbursement-can-be-more-difficult-than-not-starting-in-the-first-place
#11
E J van de Wetering, Job van Exel, Werner B F Brouwer
BACKGROUND: Conditional reimbursement of new health technologies is increasingly considered as a useful policy instrument. It allows gathering more robust evidence regarding effectiveness and cost-effectiveness of new technologies without delaying market access. Nevertheless, the literature suggests that ending reimbursement and provision of a technology when it proves not to be effective or cost-effective in practice may be difficult. OBJECTIVES: To investigate how policymakers and the general public in the Netherlands value removing a previously reimbursed treatment from the basic benefits package relative to not including a new treatment...
January 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28212687/balancing-the-health-workforce-breaking-down-overall-technical-change-into-factor-technical-change-for-labour-an-empirical-application-to-the-dutch-hospital-industry
#12
Jos L T Blank, Bart L van Hulst
BACKGROUND: Well-trained, well-distributed and productive health workers are crucial for access to high-quality, cost-effective healthcare. Because neither a shortage nor a surplus of health workers is wanted, policymakers use workforce planning models to get information on future labour markets and adjust policies accordingly. A neglected topic of workforce planning models is productivity growth, which has an effect on future demand for labour. However, calculating productivity growth for specific types of input is not as straightforward as it seems...
February 17, 2017: Human Resources for Health
https://www.readbyqxmd.com/read/28212685/factors-that-influence-children-s-gambling-attitudes-and-consumption-intentions-lessons-for-gambling-harm-prevention-research-policies-and-advocacy-strategies
#13
Hannah Pitt, Samantha L Thomas, Amy Bestman, Mike Daube, Jeffrey Derevensky
BACKGROUND: Harmful gambling is a public health issue that affects not only adults but also children. With the development of a range of new gambling products, and the marketing for these products, children are potentially exposed to gambling more than ever before. While there have been many calls to develop strategies which protect children from harmful gambling products, very little is known about the factors that may influence children's attitudes towards these products. This study aimed to explore children's gambling attitudes and consumption intentions and the range of consumer socialisation factors that may influence these attitudes and behaviours...
February 17, 2017: Harm Reduction Journal
https://www.readbyqxmd.com/read/28212435/colour-preferences-of-uk-garden-birds-at-supplementary-seed-feeders
#14
Luke Rothery, Graham W Scott, Lesley J Morrell
Supplementary feeding of garden birds generally has benefits for both bird populations and human wellbeing. Birds have excellent colour vision, and show preferences for food items of particular colours, but research into colour preferences associated with artificial feeders is limited to hummingbirds. Here, we investigated the colour preferences of common UK garden birds foraging at seed-dispensing artificial feeders containing identical food. We presented birds simultaneously with an array of eight differently coloured feeders, and recorded the number of visits made to each colour over 370 30-minute observation periods in the winter of 2014/15...
2017: PloS One
https://www.readbyqxmd.com/read/28211994/building-the-coverage-continuum-the-role-of-state-medicaid-directors-and-insurance-commissioners
#15
Joel Ario, Deborah Bachrach
Issue: The Affordable Care Act has expanded coverage to 20 million newly insured individuals, split between state Medicaid programs and commercially insured marketplaces, with limited integration between the two. The seamless continuum of coverage envisioned by the law is central to achieving the full potential of the Affordable Care Act, but it remains an elusive promise. Goals: To examine the historical and cultural differences between state Medicaid agencies and insurance departments that contribute to this lack of coordination...
2017: Issue Brief of the Commonwealth Fund
https://www.readbyqxmd.com/read/28211993/recent-lab-on-chip-developments-for-novel-drug-discovery
#16
REVIEW
Nauman Khalid, Isao Kobayashi, Mitsutoshi Nakajima
Microelectromechanical systems (MEMS) and micro total analysis systems (μTAS) revolutionized the biochemical and electronic industries, and this miniaturization process became a key driver for many markets. Now, it is a driving force for innovations in life sciences, diagnostics, analytical sciences, and chemistry, which are called 'lab-on-a-chip, (LOC)' devices. The use of these devices allows the development of fast, portable, and easy-to-use systems with a high level of functional integration for applications such as point-of-care diagnostics, forensics, the analysis of biomolecules, environmental or food analysis, and drug development...
February 17, 2017: Wiley Interdisciplinary Reviews. Systems Biology and Medicine
https://www.readbyqxmd.com/read/28211833/an-anthropometric-study-of-serbian-metal-industry-workers
#17
S Omić, V K Spasojevic Brkić, T A Golubović, A Dj Brkić, M M Klarin
BACKGROUND: There are recent studies using new industrial workers' anthropometric data in different countries, but for Serbia such data are not available. OBJECTIVE: This study is the first anthropometric study of Serbian metal industry workers in the country, whose labor force is increasingly employed both on local and international markets. The metal industry is one of Serbia's most important economic sectors. METHODS: To this end, we collected the basic static anthropometric dimensions of 122 industrial workers and used principal components analysis (PCA) to obtain multivariate anthropometric models...
February 17, 2017: Work: a Journal of Prevention, Assessment, and Rehabilitation
https://www.readbyqxmd.com/read/28211608/preclinical-characterisation-of-55p0251-a-novel-compound-that-amplifies-glucose-stimulated-insulin-secretion-and-counteracts-hyperglycaemia-in-rodents
#18
Karin Stadlbauer, Barbara Brunmair, Zsuzsanna Lehner, Immanuel Adorjan, Thomas Scherer, Anton Luger, Leonhardt Bauer, Clemens Fürnsinn
AIMS: 55P0251 is a novel compound with blood glucose lowering activity in mice, which has been developed from a molecular backbone structure found in herbal remedies. We here report its basic pharmacological attributes and initial progress in unmasking the mode of action. MATERIALS AND METHODS: Pharmacokinetic properties of 55P0251 were portrayed in several species. First efforts to elucidate the glucose lowering mechanism in rodents included numerous experimental protocols dealing with glucose tolerance, insulin secretion from isolated pancreatic islets, and comparison to established drugs...
February 17, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28211299/comparison-of-biodistribution-profile-of-monoclonal-antibodies-nanoparticles-and-aptamers-in-rats-with-breast-cancer
#19
Cristal Cerqueira-Coutinho, Sotiris Missailidis, Jéssica Alessandra-Perini, Daniel Escorsim Machado, Jamila Alessandra Perini, Ralph Santos-Oliveira
The use of monoclonal antibodies and aptamers is growing every single day, as the use of nanoparticle systems. Although most of the products are under investigation, there are a few commercialized products available at the market, for human consume. In this study, we have compared three formulations (aptamer anti-MUC1, monoclonal antibody - Trastuzumab and monoclonal antibodies nanoparticles - PLA/PVA/MMT trastuzumab) to identify their profile as also to understand their behavior into an alive biological system...
May 2017: Artificial Cells, Nanomedicine, and Biotechnology
https://www.readbyqxmd.com/read/28211195/a-comparison-of-the-new-japanese-expedited-approval-legislation-for-regenerative-medicine-product-with-the-existing-systems-of-the-united-states-and-european-union
#20
Yoji Jokura, Kazuo Yano, Masayuki Yamato
Expedited approval pathways/programs for drugs, biologics, or medical devices have been enacted for rapid product commercialization of innovative products in the United States (US) and European Union (EU). However, less innovative products are increasingly using these expedited pathways and frequently obligations to collect and report post-marketing data on approved products are being bypassed. The Japanese government recently enacted a new conditional and time-limited approval pathway dedicated to regenerative medicine products...
February 17, 2017: Journal of Tissue Engineering and Regenerative Medicine
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