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https://www.readbyqxmd.com/read/28633014/a-krabsody-for-embryo-placental-development
#1
Didier Trono
Many of the hundreds of KRAB zinc finger proteins encoded by human and mouse are involved in taming the transcriptional regulatory potential of transposable elements. Reporting recently in Science, Yang et al. (2017) reveal that one murine family member, ZFP568, controls Igf2 expression for proper embryonic and placental development.
June 19, 2017: Developmental Cell
https://www.readbyqxmd.com/read/28625099/toxicology-in-clinical-laboratories-challenging-times
#2
N W Brown
In recent years, there have been a number of significant developments in toxicology within clinical laboratories, both with the available instrumentation and in the range of compounds abused by the drug using communities. There have also been developments in the regulation of forensic science in the UK which may in time impact clinical toxicology. This review is designed to provide an update of these changes within toxicology to the more general pathology laboratory audience. For detailed information in specific areas, the reader is referred to the references in the text...
June 19, 2017: British Journal of Biomedical Science
https://www.readbyqxmd.com/read/28623185/a-web-based-data-collection-platform-for-multisite-randomized-behavioral-intervention-trials-development-key-software-features-and-results-of-a-user-survey
#3
Riddhi A Modi, Michael J Mugavero, Rivet K Amico, Jeanne Keruly, Evelyn Byrd Quinlivan, Heidi M Crane, Alfredo Guzman, Anne Zinski, Solange Montue, Katya Roytburd, Anna Church, James H Willig
BACKGROUND: Meticulous tracking of study data must begin early in the study recruitment phase and must account for regulatory compliance, minimize missing data, and provide high information integrity and/or reduction of errors. In behavioral intervention trials, participants typically complete several study procedures at different time points. Among HIV-infected patients, behavioral interventions can favorably affect health outcomes. In order to empower newly diagnosed HIV positive individuals to learn skills to enhance retention in HIV care, we developed the behavioral health intervention Integrating ENGagement and Adherence Goals upon Entry (iENGAGE) funded by the National Institute of Allergy and Infectious Diseases (NIAID), where we deployed an in-clinic behavioral health intervention in 4 urban HIV outpatient clinics in the United States...
June 16, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28619448/the-future-of-pharmaceutical-quality-and-the-path-to-get-there
#4
Lawrence X Yu, Michael Kopcha
While six sigma quality has long been achieved in other industries, it is rarely seen in the pharmaceutical sector. However, consumers and patients deserve six sigma quality pharmaceuticals with minimal risks of shortages or recalls. We propose that the future of pharmaceutical quality is six sigma, meaning that no more than 3.4 defects occur per million opportunities. We discuss the path to get there, including economic drivers, performance-based regulation, Quality by Design, advanced manufacturing technologies, and continuous improvement and operational excellence...
June 12, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28617201/a-comprehensive-review-of-regulatory-test-methods-for-endocrine-adverse-health-effects
#5
M K Manibusan, L W Touart
Development of new endocrine disruption-relevant test methods has been the subject of intensive research efforts for the past several decades, prompted in part by mandates in the 1996 Food Quality Protection Act (FQPA). While scientific understanding and test methods have advanced, questions remain on whether current scientific methods are capable of adequately addressing the complexities of the endocrine system for regulatory health and ecological risk assessments. The specific objective of this article is to perform a comprehensive, detailed evaluation of the adequacy of current test methods to inform regulatory risk assessments of whether a substance has the potential to perturb endocrine-related pathways resulting in human adverse effects...
July 2017: Critical Reviews in Toxicology
https://www.readbyqxmd.com/read/28611480/expert-consensus-document-the-international-scientific-association-for-probiotics-and-prebiotics-isapp-consensus-statement-on-the-definition-and-scope-of-prebiotics
#6
REVIEW
Glenn R Gibson, Robert Hutkins, Mary Ellen Sanders, Susan L Prescott, Raylene A Reimer, Seppo J Salminen, Karen Scott, Catherine Stanton, Kelly S Swanson, Patrice D Cani, Kristin Verbeke, Gregor Reid
In December 2016, a panel of experts in microbiology, nutrition and clinical research was convened by the International Scientific Association for Probiotics and Prebiotics to review the definition and scope of prebiotics. Consistent with the original embodiment of prebiotics, but aware of the latest scientific and clinical developments, the panel updated the definition of a prebiotic: a substrate that is selectively utilized by host microorganisms conferring a health benefit. This definition expands the concept of prebiotics to possibly include non-carbohydrate substances, applications to body sites other than the gastrointestinal tract, and diverse categories other than food...
June 14, 2017: Nature Reviews. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28611111/the-impact-of-interventions-to-improve-the-quality-of-prescribing-and-use-of-antibiotics-in-primary-care-patients-with-respiratory-tract-infections-a-systematic-review-protocol
#7
Nahara Anani Martínez-González, Samuel Coenen, Andreas Plate, Annelies Colliers, Thomas Rosemann, Oliver Senn, Stefan Neuner-Jehle
INTRODUCTION: Respiratory tract infections (RTIs) are the most common reason for primary care (PC) consultations and for antibiotic prescribing and use. The majority of RTIs have a viral aetiology however, and antibiotic consumption is ineffective and unnecessary. Inappropriate antibiotic use contributes greatly to antibiotic resistance (ABR) leading to complications, increased adverse events, reconsultations and costs. Improving antibiotic consumption is thus crucial to containing ABR, which has become an urgent priority worldwide...
June 13, 2017: BMJ Open
https://www.readbyqxmd.com/read/28610888/applying-differential-dynamic-logic-to-reconfigurable-biological-networks
#8
Daniel Figueiredo, Manuel A Martins, Madalena Chaves
Qualitative and quantitative modeling frameworks are widely used for analysis of biological regulatory networks, the former giving a preliminary overview of the system's global dynamics and the latter providing more detailed solutions. Another approach is to model biological regulatory networks as hybrid systems, i.e., systems which can display both continuous and discrete dynamic behaviors. Actually, the development of synthetic biology has shown that this is a suitable way to think about biological systems, which can often be constructed as networks with discrete controllers, and present hybrid behaviors...
June 10, 2017: Mathematical Biosciences
https://www.readbyqxmd.com/read/28608767/anxiety-and-depression-toward-overlapping-and-distinctive-features
#9
Michael W Eysenck, Małgorzata Fajkowska
This Special Issue of Cognition and Emotion addresses one of the cardinal concerns of affective science, which is overlapping and distinctive features of anxiety and depression. A central finding in the study of anxiety and depression is that they are moderately highly correlated with each other. This leads us to the question: What is behind this co-occurrence? Possible explanations relate to poor discriminant validity of measures; both emotional states are associated with negative affect; stressful life events; impaired cognitive processes; they share a common biological/genetic diathesis...
June 13, 2017: Cognition & Emotion
https://www.readbyqxmd.com/read/28604936/regulatory-science-in-neonates-a-framework-that-supports-evidence-based-drug-therapy
#10
Mark A Turner, Ronald J Portman, Jonathan M Davis
No abstract text is available yet for this article.
June 12, 2017: JAMA Pediatrics
https://www.readbyqxmd.com/read/28596049/modern-science-for-better-quality-control-of-medicinal-products-towards-global-harmonization-of-3rs-in-biologicals-the-report-of-an-epaa-workshop
#11
Katrin Schutte, Anna Szczepanska, Marlies Halder, Klaus Cussler, Ursula G Sauer, Catrina Stirling, Sylvie Uhlrich, Iwona Wilk-Zasadna, David John, Martin Bopst, Joerg Garbe, Harrie L Glansbeek, Robin Levis, Pieter-Jan Serreyn, Dean Smith, Paul Stickings
This article summarizes the outcome of an international workshop organized by the European Partnership for Alternative Approaches to Animal Testing (EPAA) on Modern science for better quality control of medicinal products: Towards global harmonization of 3Rs in biologicals. As regards the safety testing of biologicals, the workshop participants agreed to actively encourage the deletion of abnormal toxicity tests and target animal batch safety tests from all relevant legal requirements and guidance documents (country-specific guidelines, pharmacopoeia monographs, WHO recommendations)...
June 5, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28594475/what-is-safety-miracles-benefit-risk-assessments-and-the-right-to-try
#12
Lisa M DeTora
Public discourse is full of quick solutions to health care problems like cancer and rare diseases. Among these is Right to Try legislation for experimental therapies. Right to Try legislation is based on the premise that all experimental agents in clinical trials are safe and guaranteed to produce miracles. Unfortunately, this notion is at odds with expert understanding, which indicates that the benefits and risks of drug products can only be understood together and evaluated incrementally and over time. The current manuscript examines why benefit to risk considerations, a lynchpin of the ethical conduct of clinical research since the Nuremberg Code, might be easily elided from public discourse...
June 8, 2017: International Journal of Clinical Practice
https://www.readbyqxmd.com/read/28589305/discriminating-ability-of-abbreviated-impactor-measurement-approach-aim-to-detect-changes-in-mass-median-aerodynamic-diameter-mmad-of-an-albuterol-salbutamol-pmdi-aerosol
#13
J David Christopher, Rajni B Patel, Jolyon P Mitchell, Terrence P Tougas, Adrian P Goodey, Jorge Quiroz, Patrik U Andersson, Svetlana Lyapustina
This article reports on results from a two-lab, multiple impactor experiment evaluating the abbreviated impactor measurement (AIM) concept, conducted by the Cascade Impaction Working Group of the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). The goal of this experiment was to expand understanding of the performance of an AIM-type apparatus based on the Andersen eight-stage non-viable cascade impactor (ACI) for the assessment of inhalation aerosols and sprays, compared with the full-resolution version of that impactor described in the pharmacopeial compendia...
June 6, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28588568/food-safety-in-the-age-of-next-generation-sequencing-bioinformatics-and-open-data-access
#14
REVIEW
Eduardo N Taboada, Morag R Graham, João A Carriço, Gary Van Domselaar
Public health labs and food regulatory agencies globally are embracing whole genome sequencing (WGS) as a revolutionary new method that is positioned to replace numerous existing diagnostic and microbial typing technologies with a single new target: the microbial draft genome. The ability to cheaply generate large amounts of microbial genome sequence data, combined with emerging policies of food regulatory and public health institutions making their microbial sequences increasingly available and public, has served to open up the field to the general scientific community...
2017: Frontiers in Microbiology
https://www.readbyqxmd.com/read/28588155/effect-of-obesity-on-hemoglobin-concentration
#15
R Akter, A Nessa, D Sarker, M Yesmin
Obesity is a disorder of body weight regulatory systems characterized by an accumulation of excess body fat. World Health Organization recommended that 66% of deaths now occur in developing countries and recognizes obesity as a leading risk factor. Obesity is associated with chronic, low grade, systemic inflammation. The inflammatory state play a causal role in the development of insulin resistance, type 2 diabetes and the metabolic syndrome. This descriptive type of cross sectional study will design to evaluate the relation between obesity with hemoglobin concentration...
April 2017: Mymensingh Medical Journal: MMJ
https://www.readbyqxmd.com/read/28581909/development-of-crispr-cas9-mediated-virus-resistance-in-agriculturally-important-crops
#16
Surender Khatodia, Kirti Bhatotia, Narendra Tuteja
Clustered regulatory interspaced short palindromic repeats (CRISPR)/CRISPR associated nuclease 9 (Cas9) system of targeted genome editing has already revolutionized the plant science research. This is a RNA guided programmable endonuclease based system composed of 2 components, the Cas9 nuclease and an engineered guide RNA targeting any DNA sequence of the form N20-NGG for novel genome editing applications. The CRISPR/Cas9 technology of targeted genome editing has been recently applied for imparting virus resistance in plants...
May 4, 2017: Bioengineered
https://www.readbyqxmd.com/read/28580378/behavioral-economic-laboratory-research-in-tobacco-regulatory-science
#17
Jennifer W Tidey, Rachel N Cassidy, Mollie E Miller, Tracy T Smith
OBJECTIVES: Research that can provide a scientific foundation for the United States Food and Drug Administration (FDA) tobacco policy decisions is needed to inform tobacco regulatory policy. One factor that affects the impact of a tobacco product on public health is its intensity of use, which is determined, in part, by its abuse liability or reinforcing efficacy. Behavioral economic tasks have considerable utility for assessing the reinforcing efficacy of current and emerging tobacco products...
October 2016: Tobacco Regulatory Science
https://www.readbyqxmd.com/read/28578602/why-do-promising-therapies-stall-in-development-and-how-can-we-move-them-forward
#18
Craig D Wegner, Andrew Goodwin, Jon C Cook, Krishna Allamneni, Jane Sohn, Maralee McVean
There are many reasons that molecules fail to progress to market and various principles of risk-benefit decisions that can help drive the molecule through development. This symposium included discussions on global strategies involved in pushing promising molecules to market, what to do when a molecule stalls in its progress to market, and options for rescuing the molecule and pushing it forward again. Innovative partnerships that bring stalled drugs back into clinical development were also addressed. A regulatory perspective on common reasons for a molecule to fail in its forward progress was presented...
January 1, 2017: International Journal of Toxicology
https://www.readbyqxmd.com/read/28572733/the-jordan-food-and-drug-administration-comparison-of-its-registration-process-with-australia-canada-saudi-arabia-and-singapore
#19
Wesal Salem Al Haqaish, Hayel Obeidat, Prisha Patel, Stuart Walker
OBJECTIVE: This study outlines the current regulatory review process and good review practices (GRevPs) at the Jordan Food and Drug Administration (JFDA) and compares them with those of regulatory agencies in Australia, Canada, Saudi Arabia and Singapore to gauge how well the JFDA is performing. We identify opportunities for further development of the JFDA as a key global reference agency. METHODS: Personnel within the JFDA completed a questionnaire comprising four sections: organisation, key milestones, review timelines, and GRevPs...
2017: Pharmaceutical Medicine
https://www.readbyqxmd.com/read/28569255/an-evaluation-of-the-status-of-living-collections-for-plant-environmental-and-microbial-research
#20
Kevin McCLUSKEY, Jill P Parsons, Kimberly Quach, Clifford S Duke
While living collections are critical for biological research, support for these foundational infrastructure elements is inconsistent, which makes quality control, regulatory compliance, and reproducibility difficult. In recent years, the Ecological Society of America has hosted several National Science Foundation-sponsored workshops to explore and enhance the sustainability of biological research infrastructure. At the same time, the United States Culture Collection Network has brought together managers of living collections to foster collaboration and information exchange within a specific living collections community...
June 2017: Journal of Biosciences
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