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Regulatory science

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https://www.readbyqxmd.com/read/29351513/neuroimmune-interactions-from-the-brain-to-the-immune-system-and-vice-versa
#1
Robert Dantzer
Because of the compartmentalization of disciplines that shaped the academic landscape of biology and biomedical sciences in the past, physiological systems have long been studied in isolation from each other. This has particularly been the case for the immune system. As a consequence of its ties with pathology and microbiology, immunology as a discipline has largely grown independently of physiology. Accordingly, it has taken a long time for immunologists to accept the concept that the immune system is not self-regulated but functions in close association with the nervous system...
January 1, 2018: Physiological Reviews
https://www.readbyqxmd.com/read/29350396/tobacco-regulation-as-a-paradigm-for-advancing-regulatory-science-in-dermatology
#2
Harrison P Nguyen, Marney A White, Stephen K Tyring
No abstract text is available yet for this article.
January 19, 2018: International Journal of Dermatology
https://www.readbyqxmd.com/read/29350132/toward-forensic-uses-of-microbial-source-tracking
#3
Christopher M Teaf, David Flores, Michele Garber, Valerie J Harwood
The science of microbial source tracking has allowed researchers and watershed managers to go beyond general indicators of fecal pollution in water such as coliforms and enterococci, and to move toward an understanding of specific contributors to water quality issues. The premise of microbial source tracking is that characteristics of microorganisms that are strongly associated with particular host species can be used to trace fecal pollution to particular animal species (including humans) or groups, e.g., ruminants or birds...
January 2018: Microbiology Spectrum
https://www.readbyqxmd.com/read/29345179/regulatory-support-improves-subsequent-irb-approval-rates-in-studies-initially-deemed-not-ready-for-review-a-ctsa-institution-s-experience
#4
Susan Sonne, Stephanie Gentilin, Royce R Sampson, Leslie Bell, Toni Mauney, Summer Young, Katherine Bright, Patrick Flume
We evaluated the impact of a regulatory support service (known as the Regulatory Knowledge and Support [RKS] program), part of the Medical University of South Carolina's Clinical and Translational Science Award, on the success of Institutional Review Board (IRB) applications that have previously been deemed by the IRB to be Not Ready for Review (NRR). At the time of this evaluation, 77 studies had been deemed NRR, 53 of which came from trainees and junior faculty. All the applications that received regulatory support either received IRB approval or were deemed to not be research, and therefore did not require IRB review...
January 1, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/29337664/containment-studies-of-transgenic-mosquitoes-in-disease-endemic-countries-the-broad-concept-of-facilities-readiness
#5
M Megan Quinlan, Josephine Birungi, Mamadou B Coulibaly, Abdoulaye Diabaté, Luca Facchinelli, Wolfgang Richard Mukabana, James Mutuku Mutunga, Tony Nolan, Peter Raymond, Sékou F Traoré
Genetic strategies for large scale pest or vector control using modified insects are not yet operational in Africa, and currently rely on import of the modified strains to begin preliminary, contained studies. Early involvement of research teams from participating countries is crucial to evaluate candidate field interventions. Following the recommended phased approach for novel strategies, evaluation should begin with studies in containment facilities. Experiences to prepare facilities and build international teams for research on transgenic mosquitoes revealed some important organizing themes underlying the concept of "facilities readiness," or the point at which studies in containment may proceed, in sub-Saharan African settings...
January 2018: Vector Borne and Zoonotic Diseases
https://www.readbyqxmd.com/read/29332004/host-agent-vector-environment-measures-for-electronic-cigarette-research-used-in-nih-grants
#6
Mary L Garcia-Cazarin, Rachel J Mandal, Rachel Grana, Kay L Wanke, Helen I Meissner
OBJECTIVE: The purpose of this study is to describe the focus and comprehensiveness of domains measured in e-cigarette research. METHODS: A portfolio analysis of National Institutes of Health grants focusing on e-cigarette research and funded between the fiscal years 2007 and 2015 was conducted. Grant proposals were retrieved using a government database and coded using the Host-Agent-Vector-Environment (HAVE) model as a framework to characterise the measures proposed...
January 13, 2018: Tobacco Control
https://www.readbyqxmd.com/read/29330132/an-overview-of-the-safety-pharmacology-society-strategic-plan
#7
M K Pugsley, S Authier, J E Koerner, W S Redfern, C G Markgraf, T Brabham, K Correll, M V Soloviev, A Botchway, M Engwall, M Traebert, J-P Valentin, T J Mow, A Greiter-Wilke, D J Leishman, H M Vargas
Safety Pharmacology studies are conducted to characterize the confidence by which biologically active new chemical entities (NCE) may be anticipated as safe. Non-clinical safety pharmacology studies aim to detect and characterize potentially undesirable pharmacodynamic activities using an array of in silico, in vitro and in vivo animal models. While a broad spectrum of methodological innovation and advancement of the science occurs within the Safety Pharmacology Society, the society also focuses on partnerships with health authorities and technology providers and facilitates interaction with organizations of common interest such as pharmacology, physiology, neuroscience, cardiology and toxicology...
January 9, 2018: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/29329784/regulatory-science-an-underappreciated-component-of-translational-research
#8
Rodney Rouse, Issam Zineh, David G Strauss
Translational science refers to translating basic scientific findings to practical application (i.e., 'bench-to-bedside'). An underappreciated aspect of translational science is regulatory science. Herein, we focus on the importance of regulatory science to facilitate development of innovative new drugs and optimize use of approved drugs, with a call for community participation.
January 9, 2018: Trends in Pharmacological Sciences
https://www.readbyqxmd.com/read/29329724/the-potential-of-cold-plasma-for-safe-and-sustainable-food-production
#9
REVIEW
Paula Bourke, Dana Ziuzina, Daniela Boehm, Patrick J Cullen, Kevin Keener
Cold plasma science and technology is increasingly investigated for translation to a plethora of issues in the agriculture and food sectors. The diversity of the mechanisms of action of cold plasma, and the flexibility as a standalone technology or one that can integrate with other technologies, provide a rich resource for driving innovative solutions. The emerging understanding of the longer-term role of cold plasma reactive species and follow-on effects across a range of systems will suggest how cold plasma may be optimally applied to biological systems in the agricultural and food sectors...
November 30, 2017: Trends in Biotechnology
https://www.readbyqxmd.com/read/29325629/bioinformatics-and-genomic-databases
#10
Jason Chen, Giovanni Coppola
High-throughput, low-cost sequencing technologies have begun to yield new insights into biology and medicine. New data enable the interrogation of the molecular biology of disease from DNA to RNA to protein, charting the central dogma. This chapter reviews some of the key advances and resources in the application of bioinformatics to understanding, and ultimately diagnosing and treating, diseases of the nervous system. Array genotyping, exome sequencing, and whole-genome sequencing, in both disease and healthy populations, have enabled the interpretation of new genetic data...
2018: Handbook of Clinical Neurology
https://www.readbyqxmd.com/read/29322939/public-health-psychopharmacology-a-new-research-discipline-comes-of-age
#11
C Barbui, G Ostuzzi, B Godman
Research evidence guiding the identification of pragmatic and effective actions aimed at improving the selection, availability, affordability and rational prescribing of medicines for mental disorders is sparse and inconsistent. In order to boost the development of new research, in this commentary we suggest to organise and classify all the activities in this area under a common theoretical framework and nomenclature, adopting the term 'public health psychopharmacology'. Public health psychopharmacology is proposed as a research discipline, based on contributions from the fields of regulatory science, health services research and implementation science...
February 2018: Epidemiology and Psychiatric Sciences
https://www.readbyqxmd.com/read/29322155/can-the-stockholm-convention-address-the-spectrum-of-chemicals-currently-under-regulatory-scrutiny-advocating-a-more-prominent-role-for-modeling-in-pop-screening-assessment
#12
Michael S McLachlan
Frameworks for chemical regulation are based on the science at the time they were written. Today some regulations are being applied to a much broader spectrum of chemicals than we had knowledge of when the regulations were written. This entails a risk that the regulations are being used outside of their chemical application domain. This question is explored using the POP screening assessment in the Stockholm convention, which was developed 20 years ago. Using perfluorinated alkyl acids (PFAAs) as an example, it is shown that the assessment can lead to false negative conclusions...
January 11, 2018: Environmental Science. Processes & Impacts
https://www.readbyqxmd.com/read/29316278/integrated-approaches-to-testing-and-assessment-iata-oecd-activities-on-the-development-and-use-of-adverse-outcome-pathways-and-case-studies
#13
Yuki Sakuratani, Masashi Horie, Eeva Leinala
The Organisation for Economic Co-operation and Development (OECD) works with member countries and other stakeholders to improve and harmonise chemical assessment methods. In 2012, the OECD Adverse Outcome Pathways (AOPs) Development Programme started. The Programme has published six AOPs thus far and more than 60 AOPs are under various stages of development under the Programme. This paper reviews recent OECD activities on the use of AOPs in developing Integrated Approaches to Testing and Assessments (IATAs)...
January 9, 2018: Basic & Clinical Pharmacology & Toxicology
https://www.readbyqxmd.com/read/29310768/sjs-ten-2017-building-multidisciplinary-networks-to-drive-science-and-translation
#14
REVIEW
Katie D White, Riichiro Abe, Michael Ardern-Jones, Thomas Beachkofsky, Charles Bouchard, Bruce Carleton, James Chodosh, Ricardo Cibotti, Robert Davis, Joshua C Denny, Roni P Dodiuk-Gad, Elizabeth N Ergen, Jennifer L Goldman, James H Holmes, Shuen-Iu Hung, Mario E Lacouture, Rannakoe J Lehloenya, Simon Mallal, Teri A Manolio, Robert G Micheletti, Caroline M Mitchell, Maja Mockenhaupt, David A Ostrov, Rebecca Pavlos, Munir Pirmohamed, Elena Pope, Alec Redwood, Misha Rosenbach, Michael D Rosenblum, Jean-Claude Roujeau, Arturo P Saavedra, Hajirah N Saeed, Jeffery P Struewing, Hirohiko Sueki, Chonlaphat Sukasem, Cynthia Sung, Jason A Trubiano, Jessica Weintraub, Lisa M Wheatley, Kristina B Williams, Brandon Worley, Wen-Hung Chung, Neil H Shear, Elizabeth J Phillips
Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) is a life-threatening, immunologically mediated, and usually drug-induced disease with a high burden to individuals, their families, and society with an annual incidence of 1 to 5 per 1,000,000. To effect significant reduction in short- and long-term morbidity and mortality, and advance clinical care and research, coordination of multiple medical, surgical, behavioral, and basic scientific disciplines is required. On March 2, 2017, an investigator-driven meeting was held immediately before the American Academy of Dermatology Annual meeting for the central purpose of assembling, for the first time in the United States, clinicians and scientists from multiple disciplines involved in SJS/TEN clinical care and basic science research...
January 2018: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/29305516/the-dilemmas-of-science-for-policy-scientific-evidence-and-the-consequences-of-regulatory-options-in-risk-and-benefit-assessment
#15
José Luis Luján, Oliver Todt
No abstract text is available yet for this article.
January 5, 2018: EMBO Reports
https://www.readbyqxmd.com/read/29303083/patented-and-approval-scenario-of-nanopharmaceuticals-with-relevancy-to-biomedical-application-manufacturing-procedure-and-safety-aspects
#16
Vijay Agarwal, Meenakshi Bajpai, Ashish Sharma
A term 'nanopharmaceuticals' give the emphasis on the discovery, development and delivery of the drugs to the specific site using different delivery systems. Nanopharmaceutical field is a thrust area in which the development is going on progressively but the many new challenges are also arises continuously, such as regulatory requirements, identification of therapeutic targets, cost-effective and efficient tools for delivering the drug, standardization of different characterization method, etc. Some products related to this area that can be consistently and reproducibly prepared with a desired quality and is safe for the public, has been approved by the different regulatory agencies...
January 4, 2018: Recent Patents on Drug Delivery & Formulation
https://www.readbyqxmd.com/read/29302044/the-pertinence-of-sutton-s-law-to-exposure-science-lessons-from-unconventional-shale-gas-drilling
#17
REVIEW
Bernard D Goldstein
Sutton's Law urges the medical practitioner to utilize the test that goes directly to the problem. When applied to exposure science, Sutton's Law would argue that the major emphasis should be on techniques that directly measure exposure in or close to the human, animal or ecosystem receptors of concern. Exposure science largely and appropriately violates Sutton's Law by estimating exposure based on information on emissions or measurements obtained at a distance from the receptors of concern. I suggest four criteria to help determine whether Sutton's law should be violated for an innovative technology, and explore these criteria in relation to potential human exposure resulting from unconventional gas drilling (UGD): (1) The technological processes possibly leading to release of the chemical or physical agents of concern are reasonably understood; (2) the agents of concern are known; (3) the source and geographical location of the releases can be reasonably identified; and (4) there is information about the likely temporal pattern of the releases and resulting pollutant levels in relation to the temporal patterns of receptor susceptibility...
January 4, 2018: Journal of Exposure Science & Environmental Epidemiology
https://www.readbyqxmd.com/read/29300341/dietary-supplements-regulatory-challenges-and-research-resources
#18
REVIEW
Johanna T Dwyer, Paul M Coates, Michael J Smith
Many of the scientific and regulatory challenges that exist in research on the safety, quality and efficacy of dietary supplements are common to all countries as the marketplace for them becomes increasingly global. This article summarizes some of the challenges in supplement science and provides a case study of research at the Office of Dietary Supplements at the National Institutes of Health, USA, along with some resources it has developed that are available to all scientists. It includes examples of some of the regulatory challenges faced and some resources for those who wish to learn more about them...
January 4, 2018: Nutrients
https://www.readbyqxmd.com/read/29286493/twenty-five-years-of-the-national-academy-of-medical-sciences-of-ukraine-progress-and-priorities-for-future-of-radiation-medicine-and-biology
#19
D Bazyka
After the creation of the Academy of Medical Sciences of Ukraine in 1993 the Research Center for Radiation Medicine was among the first institutions to join the Academy (fig. 1). Estab lishing the Academy was among the first steps of the independent Ukrainian government and aimed to provide a high level health care for population. It was extremely needed for the minimization of Chornobyl medical consequences. This choice was related to a growing recognition of the scientific research in fulfilling the Сenter's mission - study of the effects of low dose radiation on human body and radiation protection of the exposed population...
December 2017: Problemy Radiat︠s︡iĭnoï Medyt︠s︡yny Ta Radiobiolohiï
https://www.readbyqxmd.com/read/29285958/maintaining-consistent-quality-and-clinical-performance-of-biopharmaceuticals
#20
William C Lamanna, Johann Holzmann, Hillel P Cohen, Xinghua Guo, Monika Schweigler, Thomas Stangler, Andreas Seidl, Martin Schiestl
Biopharmaceuticals are large protein based drugs which are heterogeneous by nature due to post translational modifications resulting from cellular production, processing and storage. Changes in the abundance of different variants over time are inherent to biopharmaceuticals due to their sensitivity to subtle process differences and the necessity for regular manufacturing changes. Product variability must thus be carefully controlled to ensure that it does not result in changes in safety or efficacy. Areas Covered: The focus of this manuscript is to provide improved understanding of the science and strategies used to maintain the quality and clinical performance of biopharmaceuticals, including biosimilars, throughout their lifecycle...
December 29, 2017: Expert Opinion on Biological Therapy
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