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Regulatory science

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https://www.readbyqxmd.com/read/28101455/pharmaceutical-cocrystals-regulatory-and-strategic-aspects-design-and-development
#1
REVIEW
Dipak Dilip Gadade, Sanjay Sudhakar Pekamwar
Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity...
December 2016: Advanced Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/28097613/stakeholder-contributions-to-assessment-monitoring-and-conservation-of-threatened-species-black-skimmer-and-red-knot-as-case-studies
#2
Joanna Burger, Michael Gochfeld, Larry Niles, Nellie Tsipoura, David Mizrahi, Amanda Dey, Christian Jeitner, Taryn Pittfield
Stakeholder contributions to conservation projects often occur during the problem formulation stage, yet the role of stakeholders throughout the process is seldom considered. We examine the diversity of state and federal agencies, conservation organizations, other non-governmental organizations, environmental justice communities, consultants, industry, and the general public in the conservation of red knot (Calidris canutus rufa) and black skimmer (Rynchops niger) in New Jersey. We suggest that (1) governmental agencies provide the legal, regulatory, and management framework, but it is often the universities, conservation organizations, consultants, and the public that conduct the research and perform activities that lead to increased research and conservation efforts; (2) departments within agencies may have conflicting mandates, making it difficult to resolve differences in actions; (3) there is often conflict among and within state agencies and conservation organizations about roles and priorities; and (4) the role of the public is critical to ongoing research and conservation efforts...
February 2017: Environmental Monitoring and Assessment
https://www.readbyqxmd.com/read/28096506/targeting-tnfr2-an-immune-checkpoint-stimulator-and-oncoprotein-is-a-promising-treatment-for-cancer
#3
REVIEW
Xin Chen, Joost J Oppenheim
Tumor necrosis factor receptor 2 (TNFR2) is expressed both by some cancer cells and by tumor-infiltrating immunosuppressive CD4(+)FoxP3(+) regulatory T cells (Tregs). TNFR2 stimulates the activation and proliferation of Tregs, a major checkpoint of antitumor immune responses, and promotes cancer cell survival and tumor growth. In this issue of Science Signaling, Torrey et al found that dominant antagonistic antibodies against human TNFR2 may be a potential therapy for ovarian cancer patients by simultaneously suppressing Treg activity and inducing the death of the cancer cells...
January 17, 2017: Science Signaling
https://www.readbyqxmd.com/read/28094587/applying-theories-to-better-understand-socio-political-challenges-in-implementing-evidence-based-work-disability-prevention-strategies
#4
Christian Ståhl, Katia Costa-Black, Patrick Loisel
PURPOSE: This article explores and applies theories for analyzing socio-political aspects of implementation of work disability prevention (WDP) strategies. METHOD: For the analysis, theories from political science are explained and discussed in relation to case examples from three jurisdictions (Sweden, Brazil and Québec). RESULTS: Implementation of WDP strategies may be studied through a conceptual framework that targets: (1) the institutional system in which policy-makers and other stakeholders reside; (2) the ambiguity and conflicts regarding what to do and how to do it; (3) the bounded rationality, path dependency and social systems of different stakeholders; and (4) coalitions formed by different stakeholders and power relations between them...
January 17, 2017: Disability and Rehabilitation
https://www.readbyqxmd.com/read/28092280/challenges-and-opportunities-to-enhance-global-drug-development-in-neonates
#5
Alexandra M Smith, Jonathan M Davis
PURPOSE OF REVIEW: This study reviews the history of neonatal drug development, recent legislative efforts designed to facilitate the study of therapeutic agents in neonates, and future steps necessary to advance drug development. RECENT FINDINGS: Although many federal regulations have been introduced over the past 15 years to encourage pediatric and neonatal drug development, the majority of medications that are used in the Neonatal Intensive Care Unit are not approved by the Food and Drug Administration (FDA) for use in neonates...
January 13, 2017: Current Opinion in Pediatrics
https://www.readbyqxmd.com/read/28080208/a-research-program-for-the-socioeconomic-impacts-of-gene-editing-regulation
#6
Agustina I Whelan, Martin A Lema
Gene editing technologies are a group of recent innovations in plant breeding using molecular biology, which have in common the capability of introducing a site-directed mutation or deletion in the genome. The first cases of crops improved with these technologies are approaching the market; this has raised an international debate regarding if they should be regulated as genetically modified crops or just as another form of mutagenesis under conventional breeding. This dilemma for policymakers not only entails issues pertaining safety information and legal/regulatory definitions...
January 12, 2017: GM Crops & Food
https://www.readbyqxmd.com/read/28078656/biosimilars-for-the-treatment-of-cancer-a-systematic-review-of-published-evidence
#7
REVIEW
Ira Jacobs, Reginald Ewesuedo, Sadiq Lula, Charles Zacharchuk
BACKGROUND: Biologic treatments for cancer continue to place a significant economic burden on healthcare stakeholders. Biosimilar therapies may help reduce this burden through cost savings, thereby increasing patient access. OBJECTIVES: The purpose of this study was to collate all published data to assess the weight of available evidence (quantity and quality) for proposed monoclonal antibody biosimilars and intended copies, for the treatment of cancer. METHODS: MEDLINE(®), Embase(®), and ISI Web of Science(®) databases were searched to September 2015...
January 11, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28077318/alcohol-microbiome-life-style-influence-alcohol-and-non-alcoholic-organ-damage
#8
REVIEW
Manuela G Neuman, Samuel W French, Samir Zakhari, Stefen Malnick, Helmut K Seitz, Lawrence B Cohen, Mikko Salaspuro, Andreea Voinea Griffin, Andrei Barasch, Irina A Kirpich, Paul G Thomes, Laura W Schrum, Terrence M Donohue, Kusum Kharbanda, Marcus Cruz, Mihai Opris
This paper is based upon the "8th Charles Lieber's Satellite Symposium" organized by Manuela G. Neuman at the Research Society on Alcoholism Annual Meeting, onJune 25, 2016 at New Orleans, Louisiana, USA. The integrative symposium investigated different aspects of alcohol-induced liver disease (ALD) as well as non-alcohol-induced liver disease (NAFLD) and possible repair. We revealedthe basic aspects of alcohol metabolism that may be responsible for the development of liver diseaseas well as the factors that determine the amount, frequency and which type of alcohol misuse leads to liver and gastrointestinal diseases...
January 7, 2017: Experimental and Molecular Pathology
https://www.readbyqxmd.com/read/28076528/the-brief-life-of-norplant%C3%A2-in-brazil-controversies-and-reassemblages-between-science-society-and-state
#9
Ana Cristina de Lima Pimentel, Cláudia Bonan Jannotti, Paula Gaudenzi, Luiz Antonio da Silva Teixeira
Norplant® is the brand name of the world's first registered subdermal hormonal contraceptive implant, developed by the laboratories of the Population Council, an international organisation working in the area of fertility and population growth. The article revisits the trajectory of this contraceptive in Brazil from its arrival through clinical trials to its eventual ban in 1986 by the Brazilian regulatory agency responsible for approving medications at the time. Its circulation generated controversies related to research practices, side effects and political uses of the drug as a birth control method...
January 2017: Ciência & Saúde Coletiva
https://www.readbyqxmd.com/read/28069485/alternative-approaches-for-identifying-acute-systemic-toxicity-moving-from-research-to-regulatory-testing
#10
REVIEW
Jon Hamm, Kristie Sullivan, Amy J Clippinger, Judy Strickland, Shannon Bell, Barun Bhhatarai, Bas Blaauboer, Warren Casey, David Dorman, Anna Forsby, Natàlia Garcia-Reyero, Sean Gehen, Rabea Graepel, Jon Hotchkiss, Anna Lowit, Joanna Matheson, Elissa Reaves, Louis Scarano, Catherine Sprankle, Jay Tunkel, Dan Wilson, Menghang Xia, Hao Zhu, David Allen
Acute systemic toxicity testing provides the basis for hazard labeling and risk management of chemicals. A number of international efforts have been directed at identifying non-animal alternatives for in vivo acute systemic toxicity tests. A September 2015 workshop, Alternative Approaches for Identifying Acute Systemic Toxicity: Moving from Research to Regulatory Testing, reviewed the state-of-the-science of non-animal alternatives for this testing and explored ways to facilitate implementation of alternatives...
January 6, 2017: Toxicology in Vitro: An International Journal Published in Association with BIBRA
https://www.readbyqxmd.com/read/28062252/using-neuroimaging-to-individualize-tms-treatment-for-depression-toward-a-new-paradigm-for-imaging-guided-intervention
#11
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...
January 3, 2017: NeuroImage
https://www.readbyqxmd.com/read/28058061/beyond-regulatory-compression-confronting-the-liminal-spaces-of-health-research-regulation
#12
Samuel Taylor-Alexander, Edward S Dove, Isabel Fletcher, Agomoni Ganguli Mitra, Catriona McMillan, Graeme Laurie
Biomedicine and the life sciences continuously rearrange the relationship between culture and biology. In consequence, we increasingly look for a suitable regulatory response to reduce perceived uncertainty and instability. This article examines the full implications of this 'regulatory turn' by drawing on the anthropological concept of liminality. We offer the term 'regulatory compression' to characterise the effects of extant regulatory approaches on health research practices. With its focus on transformation and the 'in-between', liminality allows us to see how regulatory frameworks rely on a silo-based approach to classifying and regulating research objects such that they: (1) limit the flexibility necessary in clinical and laboratory research; (2) result in the emergence of unregulated spaces that lie between the bounded regulatory spheres; and (3) curtail modes of public participation in the health research enterprise...
December 6, 2016: Law Innov Technol
https://www.readbyqxmd.com/read/28053899/unconventional-medical-practices-among-ghanaian-students-a-university-based-survey
#13
Razak Mohammed Gyasi, Williams Agyemang-Duah, Charlotte Monica Mensah, Francis Arthur, Roselyn Torkornoo, Padmore Adusei Amoah
Research on unconventional medical practices among students has proliferated lately in the global space, hitherto, little is known explicitly in Ghana. This paper teases out insights for recent utilisation patterns of traditional medical therapies at Kwame Nkrumah University of Science and Technology (KNUST), Ghana. A sample of 754, randomly selected undergraduates were involved in a retrospective cross-sectional survey. Data were analysed using multivariate logistic regression and Pearson's χ(2) test with p < 0...
January 2017: Journal of Traditional and Complementary Medicine
https://www.readbyqxmd.com/read/28053077/animal-research-the-3rs-and-the-internet-of-things-opportunities-and-oversight-in-international-pharmaceutical-development
#14
Steven M Niemi, Gail F Davies
Stages of drug (and vaccine) discovery and evaluation that involve laboratory animals increasingly occur via scientific collaborations across national borders and continents. Many of these research collaborations are between asset-rich institutions and others in less wealthy parts of the world. The care and use of laboratory animals in geographically disparate locations introduces new complexities, such as different oversight requirements and available resources, as well as diverse organizational and cultural milieus...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053076/opportunities-to-apply-the-3rs-in-safety-assessment-programs
#15
Fiona Sewell, Joanna Edwards, Helen Prior, Sally Robinson
Before a potential new medicine can be administered to humans it is essential that its safety is adequately assessed. Safety assessment in animals forms an integral part of this process, from early drug discovery and initial candidate selection to the program of recommended regulatory tests in animals. The 3Rs (replacement, reduction, and refinement of animals in research) are integrated in the current regulatory requirements and expectations and, in the EU, provide a legal and ethical framework for in vivo research to ensure the scientific objectives are met whilst minimizing animal use and maintaining high animal welfare standards...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053064/scientific-knowledge-and-technology-animal-experimentation-and-pharmaceutical-development
#16
Lewis B Kinter, Joseph J DeGeorge
Human discovery of pharmacologically active substances is arguably the oldest of the biomedical sciences with origins >3500 years ago. Since ancient times, four major transformations have dramatically impacted pharmaceutical development, each driven by advances in scientific knowledge, technology, and/or regulation: (1) anesthesia, analgesia, and antisepsis; (2) medicinal chemistry; (3) regulatory toxicology; and (4) targeted drug discovery. Animal experimentation in pharmaceutical development is a modern phenomenon dating from the 20th century and enabling several of the four transformations...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28049891/development-of-cellular-and-tissue-based-products-for-retinal-regenerative-medicine
#17
Fumitaka Osakada
 Since the discovery of induced pluripotent stem cells (iPSCs) generation, much progress has been made in the fields of medical and pharmaceutical research, such as cell transplantation therapy. We have generated retinal cells and tissues, including retinal pigment epithelia (RPE), from human iPSCs. The ability to produce iPSCs from patients allows for autologous transplantation without causing immune rejection. The autologous transplantation of iPSC-derived retinal pigment epithelial sheets to a patient with age-related macular degeneration was carried out in Japan in 2014 as a first-in-human clinical study...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28048780/tu-ab-204-00-cdrh-fda-regulatory-processes-and-device-science-activities
#18
Anita Nosratieh
: The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28047744/we-a-201-01-memorial-introduction
#19
C Marshall
: Chris Marshall: Memorial Introduction Donald Edmonds Herbert Jr., or Don to his colleagues and friends, exemplified the "big tent" vision of medical physics, specializing in Applied Statistics and Dynamical Systems theory. He saw, more clearly than most, that "Making models is the difference between doing science and just fooling around [ref Woodworth, 2004]". Don developed an interest in chemistry at school by "reading a book" - a recurring theme in his story. He was awarded a Westinghouse Science scholarship and attended the Carnegie Institute of Technology (later Carnegie Mellon University) where his interest turned to physics and led to a BS in Physics after transfer to Northwestern University...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28047091/we-a-201-02-modern-statistical-modeling
#20
A Niemierko
: Chris Marshall: Memorial Introduction Donald Edmonds Herbert Jr., or Don to his colleagues and friends, exemplified the "big tent" vision of medical physics, specializing in Applied Statistics and Dynamical Systems theory. He saw, more clearly than most, that "Making models is the difference between doing science and just fooling around [ref Woodworth, 2004]". Don developed an interest in chemistry at school by "reading a book" - a recurring theme in his story. He was awarded a Westinghouse Science scholarship and attended the Carnegie Institute of Technology (later Carnegie Mellon University) where his interest turned to physics and led to a BS in Physics after transfer to Northwestern University...
June 2016: Medical Physics
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