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https://www.readbyqxmd.com/read/28526659/framework-for-assessing-causality-of-air-pollution-related-health-effects-for-reviews-of-the-national-ambient-air-quality-standards
#1
Elizabeth Oesterling Owens, Molini M Patel, Ellen Kirrane, Thomas C Long, James Brown, Ila Cote, Mary A Ross, Steven J Dutton
To inform regulatory decisions on the risk due to exposure to ambient air pollution, consistent and transparent communication of the scientific evidence is essential. The United States Environmental Protection Agency (U.S. EPA) develops the Integrated Science Assessment (ISA), which contains evaluations of the policy-relevant science on the effects of criteria air pollutants and conveys critical science judgments to inform decisions on the National Ambient Air Quality Standards. This article discusses the approach and causal framework used in the ISAs to evaluate and integrate various lines of scientific evidence and draw conclusions about the causal nature of air pollution-induced health effects...
May 16, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28525648/the-role-of-omics-in-the-application-of-adverse-outcome-pathways-for-chemical-risk-assessment
#2
Erica K Brockmeier, Geoff Hodges, Thomas H Hutchinson, Emma Butler, Markus Hecker, Knut Erik Tollefsen, Natalia Garcia-Reyero, Peter Kille, Dörthe Becker, Kevin Chipman, John Colbourne, Timothy W Collette, Andrew Cossins, Mark Cronin, Peter Graystock, Steve Gutsell, Dries Knapen, Ioanna Katsiadaki, Anke Lange, Stuart Marshall, Stewart F Owen, Edward J Perkins, Stewart Plaistow, Anthony Schroeder, Daisy Taylor, Mark Viant, Gerald Ankley, Francesco Falciani
In conjunction with the second International Environmental Omics Symposium (iEOS) conference, held at the University of Liverpool (UK) in September 2014, a workshop was held to bring together experts in toxicology and regulatory science from academia, government and industry. The purpose of the workshop was to review the specific roles that high-content omics datasets (e.g., transcriptomics, metabolomics, lipidomics, and proteomics) can hold within the adverse outcome pathway (AOP) framework for supporting ecological and human health risk assessments...
May 19, 2017: Toxicological Sciences: An Official Journal of the Society of Toxicology
https://www.readbyqxmd.com/read/28524743/nanoparticle-exposures-from-nano-enabled-toner-based-printing-equipment-and-human-health-state-of-science-and-future-research-needs
#3
Sandra Vanessa Pirela, John Martin, Dhimiter Bello, Philip Demokritou
Toner formulations used by laser printers (LP) and photocopiers (PC), collectively called "toner-based printing equipment" (TPE), are nano-enabled products (NEP) because they contain several engineered nanomaterials (ENM) that improve toner performance. It has been shown that during consumer use (printing), these ENM are released in the air, together with other semi-volatile organic nanoparticles, and newly formed gaseous co-pollutants such as volatile organic compounds (VOC). The aim of this review is to detail and analyze physico-chemical and morphological (PCM), as well as the toxicological properties of particulate matter (PM) emissions from TPE...
May 19, 2017: Critical Reviews in Toxicology
https://www.readbyqxmd.com/read/28516359/evolution-of-choice-of-solubility-and-dissolution-media-after-two-decades-of-biopharmaceutical-classification-system
#4
Nadia Bou-Chacra, Katherine Jasmine Curo Melo, Ivan Andrés Cordova Morales, Erika S Stippler, Filippos Kesisoglou, Mehran Yazdanian, Raimar Löbenberg
The introduction of the biopharmaceutics drug classification system (Biopharmaceutics Classification System (BCS)), in 1995, provided a simple way to describe the biopharmaceutics behavior of a drug. Solubility and permeability are among the major parameters, which determine the fraction dose absorbed of a drug substance and consequently its chances to be bioavailable. The purpose of this review is to summarize the evolution of the media used for determining solubility and dissolution and how this can be used in modern drug development...
May 17, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28506248/paraquat-and-parkinson-s-disease-a-systematic-review-protocol-according-to-the-ohat-approach-for-hazard-identification
#5
Carolina Vaccari, Regina El Dib, João Lauro V de Camargo
BACKGROUND: Parkinson's disease (PD) is a progressive neurodegenerative condition that has genetic susceptibility, aging, and exposure to certain chemicals as risk factors. In recent decades, epidemiological and experimental studies have investigated the role of pesticides in the development of PD, in particular that of the herbicide paraquat. Here, we, therefore, aim to systematically review the association between paraquat exposure and PD. METHODS: Observational studies (cohort, case-control, and cross-sectional) eligible for this systematic review will enroll any participant who was occupationally and/or environmentally exposed to paraquat...
May 15, 2017: Systematic Reviews
https://www.readbyqxmd.com/read/28505393/the-science-behind-one-health-at-the-interface-of-humans-animals-and-the-environment
#6
Michael P Murtaugh, Clifford J Steer, Srinand Sreevatsan, Ned Patterson, Shaun Kennedy, P Sriramarao
Humans face a grand quality-of-life challenge as growing demands for resources for an ever-expanding population threaten the existence of wildlife populations, degrade land, and pollute air and water. Public investment and policy decisions that will shape future interactions of humans, animals, and the environment need scientific input to help find common ground for durable and sustainable success. The Second International Conference on One Medicine One Science brought together a broad range of scientists, trainees, regulatory authorities, and health experts from 34 countries to inform and discuss the human impacts of air quality; the complexities of water quality, access, and conflicts; the opportunities and uncertainties in precision medicine; and the role of science communication in health policy formulation...
May 2017: Annals of the New York Academy of Sciences
https://www.readbyqxmd.com/read/28504870/a-critical-evaluation-of-the-current-p-value-controversy
#7
REVIEW
Stefan Wellek
This article has been triggered by the initiative launched in March 2016 by the Board of Directors of the American Statistical Association (ASA) to counteract the current p-value focus of statistical research practices that allegedly "have contributed to a reproducibility crisis in science." It is pointed out that in the very wide field of statistics applied to medicine, many of the problems raised in the ASA statement are not as severe as in the areas the authors may have primarily in mind, although several of them are well-known experts in biostatistics and epidemiology...
May 15, 2017: Biometrical Journal. Biometrische Zeitschrift
https://www.readbyqxmd.com/read/28502015/product-development-and-commercialization-of-diagnostic-or-life-science-products-for-scientists-and-researchers
#8
Meghan M Alonso
Commercializing a diagnostic or life science product often encompasses different goals than that of research and grant funding. There are several necessary steps, and a strategy needs to be well defined in order to be successful. Product development requires input from and between various groups within a company and, for academia, outside entities. The product development stakeholder groups/entities are research, marketing, development, regulatory, manufacturing, clinical, safety/efficacy, and quality. After initial research and development, much of the work in product development can be outsourced or jointly created using public-private partnerships...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28501991/innovations-in-clinical-trial-design-in-the-era-of-molecular-profiling
#9
Julia D Wulfkuhle, Alexander Spira, Kirsten H Edmiston, Emanuel F Petricoin
Historically, cancer has been studied, and therapeutic agents have been evaluated based on organ site, clinical staging, and histology. The science of molecular profiling has expanded our knowledge of cancer at the cellular and molecular level such that numerous subtypes are being described based on biomarker expression and genetic mutations rather than traditional classifications of the disease. Drug development has experienced a concomitant revolution in response to this knowledge with many new targeted therapeutic agents becoming available, and this has necessitated an evolution in clinical trial design...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28496147/combination-products-modernizing-the-regulatory-paradigm
#10
Nina L Hunter, Rachel E Sherman
New opportunities to develop innovative - and often complex - products that combine drugs, devices and/or biological components are rapidly emerging, raising questions about how such products should be regulated. Here, we discuss the ongoing efforts of the FDA to develop a modern, transparent, flexible and consistent science-based regulatory approach for combination products.
May 12, 2017: Nature Reviews. Drug Discovery
https://www.readbyqxmd.com/read/28493091/-violence-against-the-elderly-in-domestic-care-settings-short-profile-of-an-interdisciplinary-research-project
#11
REVIEW
Anna Schwedler, Nadine Konopik, Lukas Heber, Marina Wellenhofer, Frank Oswald, Gisela Zenz, Ludwig Salgo
Most elderly people wish to remain and be cared for in their own home. Approximately 1.38 million people in Germany are cared for without professional support. However, domestic care by relatives can be a risk factor for violence against the elderly. This research project deals with the issue from a legal and social sciences perspective. The aim of the project is to develop a regulatory framework providing aid-oriented prevention and intervention in the family care of vulnerable elderly people by public agencies and courts...
May 10, 2017: Zeitschrift Für Gerontologie und Geriatrie
https://www.readbyqxmd.com/read/28491135/highlights-from-the-15th-st-gallen-international-breast-cancer-conference-15-18-march-2017-vienna-tailored-treatments-for-patients-with-early-breast-cancer
#12
Consuelo Morigi
The 15th St Gallen International Breast Cancer Conference was held in Vienna for the second time, from 15th-18th March 2017. 4000 people from 105 countries all over the world were invited to take part in the event. The real highlight of the conference was the last day with the International Consensus Session which was chaired by around 50 experts on breast cancer worldwide. With reference to data from scientific research, the consensus panel tried to offer guidelines for the management of breast cancer with the aim of providing patients with optimal treatment...
2017: Ecancermedicalscience
https://www.readbyqxmd.com/read/28487498/clinicopathologic-and-prognostic-significance-of-regulatory-t-cells-in-patients-with-hepatocellular-carcinoma-a-meta-analysis
#13
REVIEW
Lejia Sun, Gang Xu, Wenjun Liao, Huayu Yang, Haifeng Xu, Shunda Du, Haitao Zhao, Xin Lu, Xinting Sang, Yilei Mao
The clinicopathologic and prognostic significance of regulatory T cells (Tregs) in patients with hepatocellular carcinoma (HCC) remains controversial. We performed a meta-analysis to resolve this issue. PubMed, Embase, Cochrane library, and the Web of Science were searched to identify eligible studies performed up to November 2016. A total of 3,854 HCC patients from 27 cohort studies were included. The meta-analysis revealed that high levels of Tregs were associated with poor overall survival (OS; HR = 1.95, P<0...
April 21, 2017: Oncotarget
https://www.readbyqxmd.com/read/28487418/science-signaling-podcast-for-9-may-2017-trafficking-of-bk-channel-subunits-in-arterial-myocytes
#14
Jonathan H Jaggar, Annalisa M VanHook
This Podcast features a conversation with Jonathan Jaggar, senior author of a Research Article that appears in the 9 May 2017 issue of Science Signaling, about trafficking of big potassium (BK) channel subunits in arterial myocytes. Depolarization of the arterial myocyte membrane causes a rise in intracellular calcium that stimulates the cell to contract, which leads to vasoconstriction. Membrane depolarization also activates BK channels, which allow potassium to flow out of the cell, thus repolarizing the membrane and promoting vasodilation...
May 9, 2017: Science Signaling
https://www.readbyqxmd.com/read/28486906/safety-and-toxicological-considerations-of-nanomedicines-the-future-directions
#15
Parmi Patel, Jigna Shah
Nanomedicine, an emerging nanotechnology, imparts special biological features due to their quantum size and is a promising candidate for targeted drug delivery. At present, in spite of its novel applications in medical sciences, certain existing gaps still needs to be addressed such as fate of nanoparticles and its toxicity assessment on human health. Behaviour of the entities post human body exposure and its deposition up to certain extent are some of the crucial factors to be considered for a successful treatment approach...
May 9, 2017: Current Clinical Pharmacology
https://www.readbyqxmd.com/read/28483710/current-nonclinical-testing-paradigms-in-support-of-safe-clinical-trials-an-iq-consortium-drusafe-perspective
#16
Lynne D Butler, Peggy Guzzie-Peck, James Hartke, Matthew S Bogdanffy, Yvonne Will, Dolores Diaz, Elisabeth Mortimer-Cassen, Mazin Derzi, Nigel Greene, Joseph J DeGeorge
The transition from nonclinical to First-in-Human (FIH) testing is one of the most challenging steps in drug development. In response to serious outcomes in a recent Phase 1 trial (sponsored by Bial), IQ Consortium/DruSafe member companies reviewed their nonclinical approach to progress small molecules safely to FIH trials. As a common practice, safety evaluation begins with target selection and continues through iterative in silico and in vitro screening to identify molecules with increased probability of acceptable in vivo safety profiles...
May 5, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28480206/cell-secretome-based-drug-substances-in-regenerative-medicine-when-regulatory-affairs-meet-basic-science
#17
EDITORIAL
Lucian Beer, Michael Mildner, Hendrik Jan Ankersmit
No abstract text is available yet for this article.
April 2017: Annals of Translational Medicine
https://www.readbyqxmd.com/read/28476213/reprint-of-using-neuroimaging-to-individualize-tms-treatment-for-depression-toward-a-new-paradigm-for-imaging-guided-intervention
#18
Bruce M Luber, Simon Davis, Elisabeth Bernhardt, Andrada Neacsiu, Lori Kwapil, Sarah H Lisanby, Timothy J Strauman
The standard clinical technique for using repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder (MDD) is associated with limited efficacy to date. Such limited efficacy may be due to reliance on scalp-based targeting rather than state-of-the-science methods which incorporate fMRI-guided neuronavigation based on a specific model of neurocircuit dysfunction. In this review, we examine such a specific model drawn from regulatory focus theory, which postulates two brain/behavior systems, the promotion and prevention systems, underlying goal pursuit...
May 1, 2017: NeuroImage
https://www.readbyqxmd.com/read/28476066/angiodysplasia-in-von-willebrand-disease-understanding-the-clinical-and-basic-science
#19
Soundarya Selvam, Paula James
Severe and intractable gastrointestinal bleeding caused by angiodysplasia is a debilitating problem for up to 20% of patients with von Willebrand disease (VWD). Currently, the lack of an optimal treatment for this recurrent problem presents an ongoing challenge for many physicians in their management of affected patients. Over the past few years, studies have pointed to a regulatory role for the hemostatic protein, von Willebrand factor (VWF), in angiogenesis, providing a novel target for the modulation of vessel development...
May 5, 2017: Seminars in Thrombosis and Hemostasis
https://www.readbyqxmd.com/read/28462793/biosimilars-to-recombinant-human-fsh-medicines-comparable-efficacy-and-safety-to-the-original-biologic
#20
Fernando de Mora, Bart C J M Fauser
Two recombinant follicle-stimulating hormone (rFSH)-bearing similar biological medicines (biosimilars) have been authorized by the European Commission. Biosimilar is a regulatory concept alluding to the evidence-based high-standard comparability studies needed to demonstrate its equivalence to a reference original biologic. Because biosimilar development represents a shift from the long-lasting existing paradigms, a thorough understanding of the science behind it will contribute to helping prescribers make informed treatment choices...
April 10, 2017: Reproductive Biomedicine Online
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