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https://www.readbyqxmd.com/read/29792459/teamwork-in-healthcare-key-discoveries-enabling-safer-high-quality-care
#1
Michael A Rosen, Deborah DiazGranados, Aaron S Dietz, Lauren E Benishek, David Thompson, Peter J Pronovost, Sallie J Weaver
Few industries match the scale of health care. In the United States alone, an estimated 85% of the population has at least 1 health care encounter annually and at least one quarter of these people experience 4 to 9 encounters annually. A single visit requires collaboration among a multidisciplinary group of clinicians, administrative staff, patients, and their loved ones. Multiple visits often occur across different clinicians working in different organizations. Ineffective care coordination and the underlying suboptimal teamwork processes are a public health issue...
May 2018: American Psychologist
https://www.readbyqxmd.com/read/29789981/research-driven-policy-is-financial-capacity-related-to-dangerousness
#2
Patrick H DeLeon, Maegan M Paxton, Tonya Spencer, Jouhayna E Bajjani-Gebara
Current Veterans administration policy directly links a Veteran's adjudged capacity to manage personal financial resources with their ability to purchase or possess a firearm, pursuant to the regulatory authority of the National Instant Criminal Background Check System (NICS). Preventing Veterans' suicide is a highly laudable public health objective. Effectively utilizing scientific research to "inform" public policy is equally important. The authors should be congratulated for their efforts. However, it is important in utilizing large set population-based data, especially social science data, to evaluate policy alternatives that there be substantial face (i...
May 22, 2018: Administration and Policy in Mental Health
https://www.readbyqxmd.com/read/29788463/e-cigarette-science-and-its-relevance-for-regulatory-actions-and-policy
#3
Ray Niaura
No abstract text is available yet for this article.
May 16, 2018: Nicotine & Tobacco Research: Official Journal of the Society for Research on Nicotine and Tobacco
https://www.readbyqxmd.com/read/29784433/fda-and-nist-collaboration-on-standards-development-activities-supporting-innovation-and-translation-of-regenerative-medicine-products
#4
Judith A Arcidiacono, Steven R Bauer, David S Kaplan, Clare M Allocca, Sumona Sarkar, Sheng Lin-Gibson
The development of standards for the field of regenerative medicine has been noted as a high priority by several road-mapping activities. Additionally, the U.S. Congress recognizes the importance of standards in the 21st Century Cure Act. Standards will help to accelerate and streamline cell and gene therapy product development, ensure the quality and consistency of processes and products, and facilitate their regulatory approval. Although there is general agreement for the need of additional standards for regenerative medicine products, a shared understanding of standards is required for real progress toward the development of standards to advance regenerative medicine...
May 18, 2018: Cytotherapy
https://www.readbyqxmd.com/read/29773774/us-and-cuban-scientists-forge-collaboration-on-arbovirus-research
#5
Jorge Pérez-Ávila, Maria G Guzmán-Tirado, Jorge Fraga-Nodarse, Gray Handley, James Meegan, Jose L Pelegrino-Martínez de la Cotera, Anthony S Fauci
After December 17, 2014, when the US and Cuban governments announced their intent to restore relations, the two countries participated in various exchange activities in an effort to encourage cooperation in public health, health research and biomedical sciences. The conference entitled Exploring Opportunities for Arbovirus Research Collaboration, hosted at Havana's Hotel Nacional, was part of these efforts and was the first major US-Cuban scientific conference in over 50 years. Its purpose was to share information about current arbovirus research and recent findings, and to explore opportunities for future joint research...
April 2018: MEDICC Review
https://www.readbyqxmd.com/read/29773196/reconsideration-of-the-immunotherapeutic-pediatric-safe-dose-levels-of-aluminum
#6
James Lyons-Weiler, Robert Ricketson
FDA regulations require safety testing of constituent ingredients in drugs (21 CFR 610.15). With the exception of extraneous proteins, no component safety testing is required for vaccines or vaccine schedules. The dosing of aluminum in vaccines is based on the production of antibody titers, not safety science. Here we estimate a Pediatric Dose Limit that considers body weight. We identify several serious historical missteps in past analyses of provisional safe levels of aluminum in vaccines, and provide updates relevant to infant aluminum exposure in the pediatric schedule considering pediatric body weight...
July 2018: Journal of Trace Elements in Medicine and Biology
https://www.readbyqxmd.com/read/29773056/nanocrystals-technology-for-pharmaceutical-science
#7
Zhongyao Cheng, Yumei Lian, Zul Kamal, Xin Ma, Jianjun Chen, Xinbo Zhou, Jing Su, Mingfeng Qiu
BACKGROUND: Nanocrystals technology is a promising method for improving the dissolution rate and enhancing the bioavailability of poorly soluble drugs. In recent years, it has been developing rapidly and applied to drug research and engineering. Nanocrystal drugs can be formulated into various dosage forms. OBJECTIVE: This review mainly focused on the nanocrystals technology and its application in pharmaceutical science. Firstly, different preparation methods of nanocrystal technology and the characterization of nanocrystal drugs are briefly described...
May 17, 2018: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/29768712/innovation-at-the-intersection-of-clinical-trials-and-real-world-data-science-to-advance-patient-care
#8
REVIEW
Brandon Swift, Lokesh Jain, Craig White, Vasu Chandrasekaran, Aman Bhandari, Dyfrig A Hughes, Pravin R Jadhav
While efficacy and safety data collected from randomized clinical trials are the evidentiary standard for determining market authorization, this alone may no longer be sufficient to address the needs of key stakeholders (regulators, providers, and payers) and guarantee long-term success of pharmaceutical products. There is a heightened interest from stakeholders on understanding the use of real-world evidence (RWE) to substantiate benefit-risk assessment and support the value of a new drug. This review provides an overview of real-world data (RWD) and related advances in the regulatory framework, and discusses their impact on clinical research and development...
May 16, 2018: Clinical and Translational Science
https://www.readbyqxmd.com/read/29764324/baby-m-turns-30-the-law-and-policy-of-surrogate-motherhood
#9
Eric A Feldman
This article marks the 30th anniversary of the Supreme Court of New Jersey's Baby M decision by offering a critical analysis of surrogacy policy in the United States. Despite fundamental changes in both science and society since the case was decided, state courts and legislatures remain bitterly divided on the legality of surrogacy. In arguing for a more uniform, permissive legal posture toward surrogacy, the article addresses five central debates in the surrogacy literature. First, should the legal system accommodate those seeking conception through surrogacy, or should it prohibit such arrangements? Second, if surrogacy is permitted, what steps can be taken to minimize the potential exploitation of women who are willing to rent their wombs for income? Third, what criteria should govern the eligibility to serve as a surrogate mother and an intended parent? Fourth, what principle(s) should serve as the basis for determining the parentage of children born through surrogacy? Fifth, is regulatory uniformity in the surrogacy realm desirable? Is it achievable? The article concludes that courts and legislatures should accept the validity of surrogacy contracts, determine parentage according to intent, and identify transparent criteria for the eligibility of both surrogates and intended parents...
March 2018: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/29763344/from-the-valley-of-death-to-the-crossroads-of-opportunity-a-discussion-of-evolving-benefit-risk-evaluation-standards
#10
Peter J Pitts, Patrick Brady
A series of recent US Food and Drug Administration (FDA) approvals (such as Sarepta's Exondys 51, Merck's Keytruda, and Portola's Bevyxxa) has generated significant interest within the drug development ecosystem. Facilitated regulatory pathways aimed toward expediting medicines to patients suffering from serious and life-threatening conditions are a good thing, even if it raises curiosity and introduces some degree of uncertainty. Over the last 20 years, two key words in drug development have been speed and innovation...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29755928/the-effects-of-social-support-on-strenuous-physical-exercise
#11
Arran Davis, Emma Cohen
In humans, socio-environmental cues play an important role in determining adaptive psychophysiological states and behaviours. In sport and exercise, cues to cohesive groups and close, supportive relationships are ubiquitous, possibly because of their effects on neurobiological mechanisms underlying physical performance. Clinical research has shown that the presence of supportive others can lead to reductions in perceptions of pain, while research from sport and exercise science has shown that pain and physical fatigue occupy ranges on a single spectrum of physical discomfort, which works to regulate outputs during strenuous physical exertion...
2018: Adaptive Human Behavior and Physiology
https://www.readbyqxmd.com/read/29748817/the-role-of-the-microbiome-for-human-health-from-basic-science-to-clinical-applications
#12
M Hasan Mohajeri, Robert J M Brummer, Robert A Rastall, Rinse K Weersma, Hermie J M Harmsen, Marijke Faas, Manfred Eggersdorfer
The 2017 annual symposium organized by the University Medical Center Groningen in The Netherlands focused on the role of the gut microbiome in human health and disease. Experts from academia and industry examined interactions of prebiotics, probiotics, or vitamins with the gut microbiome in health and disease, the development of the microbiome in early-life and the role of the microbiome on the gut-brain axis. The gut microbiota changes dramatically during pregnancy and intrinsic factors (such as stress), in addition to extrinsic factors (such as diet, and drugs) influence the composition and activity of the gut microbiome throughout life...
May 10, 2018: European Journal of Nutrition
https://www.readbyqxmd.com/read/29748717/ethical-challenges-in-resuscitation
#13
REVIEW
Spyros D Mentzelopoulos, Anne-Marie Slowther, Zoe Fritz, Claudio Sandroni, Theodoros Xanthos, Clifton Callaway, Gavin D Perkins, Craig Newgard, Eleni Ischaki, Robert Greif, Erwin Kompanje, Leo Bossaert
PURPOSE: A rapidly evolving resuscitation science provides more effective treatments to an aging population with multiple comorbidites. Concurrently, emergency care has become patient-centered. This review aims to describe challenges associated with the application of key principles of bioethics in resuscitation and post-resuscitation care; propose actions to address these challenges; and highlight the need for evidence-based ethics and consensus on ethical principles interpretation. METHODS: Following agreement on the article's outline, subgroups of 2-3 authors provided narrative reviews of ethical issues concerning autonomy and honesty, beneficence/nonmaleficence and dignity, justice, specific practices/circumstances such as family presence during resuscitation, and emergency research...
May 10, 2018: Intensive Care Medicine
https://www.readbyqxmd.com/read/29741731/expression-of-grim-19-in-unexplained-recurrent-spontaneous-abortion-and-possible-pathogenesis
#14
Yang Yang, Laiyang Cheng, Xiaohui Deng, Hongling Yu, Lan Chao
STUDY QUESTION: Is aberrant expression of gene associated with retinoid-interferon-induced mortality-19 (GRIM-19) associated with unexplained recurrent spontaneous abortion (URSA)? SUMMARY ANSWER: GRIM-19 deficiency may regulate regulatory T cell/ T helper 17 cell (Treg/Th17) balance partly through reactive oxygen species (ROS) - mammalian target of rapamycin (mTOR) signaling axis in URSA. WHAT IS KNOWN ALREADY: Immunological disorders may cause impaired maternal immune tolerance to the fetus and result in fetal rejection...
May 8, 2018: Molecular Human Reproduction
https://www.readbyqxmd.com/read/29723060/a-milestone-therapeutic-innovation-regulatory-science-has-been-accepted-for-inclusion-in-medline
#15
J Rick Turner
No abstract text is available yet for this article.
May 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29714614/medical-writing-competency-model-section-2-knowledge-skills-abilities-and-behaviors
#16
David B Clemow, Bertil Wagner, Christopher Marshallsay, Dan Benau, Darryl L'Heureux, David H Brown, Devjani Ghosh Dasgupta, Eileen Girten, Frank Hubbard, Helle-Mai Gawrylewski, Hiroko Ebina, Janet Stoltenborg, J P York, Kim Green, Linda Fossati Wood, Lisa Toth, Michael Mihm, Nancy R Katz, Nina-Maria Vasconcelos, Norihisa Sakiyama, Robin Whitsell, Shobha Gopalakrishnan, Susan Bairnsfather, Tatyana Wanderer, Thomas M Schindler, Yeshi Mikyas, Yumiko Aoyama
This article provides Section 2 of the 2017 Edition 2 Medical Writing Competency Model that describes the knowledge, skills, abilities, and behaviors that professional medical writers need in order to perform effectively within the life sciences industry. What a medical writer should know, what they should be able to do, and how they should use this knowledge and these skills to facilitate their primary work function is a focus. Regulatory, publication, and other scientific writing as well as management of writing activities are covered...
January 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29714611/medical-writing-competency-model-section-1-functions-tasks-and-activities
#17
David B Clemow, Bertil Wagner, Christopher Marshallsay, Dan Benau, Darryl L'Heureux, David H Brown, Devjani Ghosh Dasgupta, Eileen Girten, Frank Hubbard, Helle-Mai Gawrylewski, Hiroko Ebina, Janet Stoltenborg, J P York, Kim Green, Linda Fossati Wood, Lisa Toth, Michael Mihm, Nancy R Katz, Nina-Maria Vasconcelos, Norihisa Sakiyama, Robin Whitsell, Shobha Gopalakrishnan, Susan Bairnsfather, Tatyana Wanderer, Thomas M Schindler, Yeshi Mikyas, Yumiko Aoyama
This article provides Section 1 of the 2017 Edition 2 Medical Writing Competency Model that describes the core work functions and associated tasks and activities related to professional medical writing within the life sciences industry. The functions in the Model are scientific communication strategy; document preparation, development, and finalization; document project management; document template, standard, format, and style development and maintenance; outsourcing, alliance partner, and client management; knowledge, skill, ability, and behavior development and sharing; and process improvement...
January 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29714583/recent-advances-in-drug-development-and-regulatory-science-in-china
#18
Jie Chen, Naiqing Zhao
As the second largest pharmaceutical market with a great potential for future growth, China has drawn much attention from the global pharmaceutical community. With an increasing government investment in biomedical research, the domestic biopharmaceutical (biotechnological) companies in China are turning their attention to the development of innovative medicines and targeting the global market. To introduce innovative products to Chinese patients sooner, to improve the efficiency of its review and approval processes, and to harmonize its regulatory science with international standards, the China Food and Drug Administration (CFDA) has initiated a series of major changes to its policies and regulations...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29707216/cutting-edges-and-weaving-threads-in-the-gene-editing-%C3%B0-evolution-reconciling-scientific-progress-with-legal-ethical-and-social-concerns
#19
Ana Nordberg, Timo Minssen, Sune Holm, Maja Horst, Kell Mortensen, Birger Lindberg Møller
Gene-editing technology, such as CRISPR/Cas9, holds great promise for the advancement of science and many useful applications technology. This foundational technology enables modification of the genetic structure of any living organisms with unprecedented precision. Yet, in order to enhance its potential for societal benefit, it is necessary to adapt rules and produce adequate regulations. This requires an interdisciplinary effort in legal thinking. Any legislative initiative needs to consider both the benefits and the problematic aspects of gene editing, from a broader societal and value-based perspective...
May 2018: Journal of Law and the Biosciences
https://www.readbyqxmd.com/read/29704969/a-pilot-study-of-emotion-regulation-therapy-for-generalized-anxiety-and-depression-findings-from-a-diverse-sample-of-young-adults
#20
Megan E Renna, Jean M Quintero, Ariella Soffer, Martin Pino, Leslie Ader, David M Fresco, Douglas S Mennin
Emotion regulation therapy (ERT) for generalized anxiety disorder (GAD) and accompanying major depressive disorder (MDD) is a theoretically derived, evidence-based treatment that integrates principles from traditional and contemporary cognitive-behavioral and experiential approaches with basic and translational findings from affect science to offer a blueprint for improving intervention by focusing on the motivational responses and corresponding self-referential regulatory characteristics. Preliminary evidence supports the efficacy of a 20-session version of ERT...
May 2018: Behavior Therapy
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