keyword
MENU ▼
Read by QxMD icon Read
search

Regulatory science

keyword
https://www.readbyqxmd.com/read/28734756/3d-bioprinting-for-reconstructive-surgery-principles-applications-and-challenges
#1
REVIEW
Zita M Jessop, Ayesha Al-Sabah, Matthew D Gardiner, Emman Combellack, Karl Hawkins, Iain S Whitaker
Despite the increasing laboratory research in the growing field of 3D bioprinting, there are few reports of successful translation into surgical practice. This review outlines the principles of 3D bioprinting including software and hardware processes, biocompatible technological platforms and suitable bioinks. The advantages of 3D bioprinting over traditional tissue engineering techniques in assembling cells, biomaterials and biomolecules in a spatially controlled manner to reproduce native tissue macro-, micro- and nanoarchitectures are discussed, together with an overview of current progress in bioprinting tissue types relevant for plastic and reconstructive surgery...
June 9, 2017: Journal of Plastic, Reconstructive & Aesthetic Surgery: JPRAS
https://www.readbyqxmd.com/read/28733961/a-review-of-biomarkers-for-neurodegenerative-disease-will-they-swing-us-across-the-valley
#2
REVIEW
Thomas G Beach
Measures of the severity of cognitive impairment or parkinsonism are the usual endpoints in clinical trials for Alzheimer's disease (AD) and Parkinson's disease (PD), but are critically hampered by their lack of disease sensitivity and specificity. Due to the high failure rate of clinical trials, the rate of regulatory approval for efficacious new drugs has stagnated in the past few decades, with the gap between basic science discovery and clinical application metaphorically termed the "Valley of Death". While the causes for this are probably multiple and complex, the usage of biomarkers as surrogate endpoints, particularly when they are molecularly-specific for the disease, has achieved some success in cancer trials, and it is likely that neurodegenerative disease trials would benefit from the same approach...
July 2017: Neurology and Therapy
https://www.readbyqxmd.com/read/28729174/challenges-and-strategies-to-facilitate-formulation-development-of-pediatric-drug-products-safety-qualification-of-excipients
#3
Lorrene A Buckley, Smita Salunke, Karen Thompson, Gerri Baer, Darren Fegley, Mark A Turner
A public workshop entitled "Challenges and strategies to facilitate formulation development of pediatric drug products" focused on current status and gaps as well as recommendations for risk-based strategies to support the development of pediatric age-appropriate drug products. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary, panel, and case-study breakout sessions. By enabling practical and meaningful discussion between scientists representing the diversity of involved disciplines (formulators, nonclinical scientists, clinicians, and regulators) and geographies (eg, US, EU), the Excipients Safety workshop session was successful in providing specific and key recommendations for defining paths forward...
July 17, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28724732/integrating-regulatory-surveys-and-citizen-science-to-map-outbreaks-of-forest-diseases-acute-oak-decline-in-england-and-wales
#4
Nathan Brown, Frank van den Bosch, Stephen Parnell, Sandra Denman
The number of emerging tree diseases has increased rapidly in recent times, with severe environmental and economic consequences. Systematic regulatory surveys to detect and establish the distribution of pests are crucial for successful management efforts, but resource-intensive and costly. Volunteers who identify potential invasive species can form an important early warning network in tree health; however, what these data can tell us and how they can be best used to inform and direct official survey effort is not clear...
July 26, 2017: Proceedings. Biological Sciences
https://www.readbyqxmd.com/read/28720347/transgenesis-affects-endogenous-soybean-allergen-levels-less-than-traditional-breeding
#5
Ryan C Hill, Brandon J Fast, Rod A Herman
The regulatory body that oversees the safety assessment of genetically modified (GM) crops in the European Union, the European Food Safety Authority (EFSA), uniquely requires that endogenous allergen levels be quantified as part of the compositional characterization of GM versions of crops, such as soybean, that are considered to be major allergenic foods. The value of this requirement for assessing food safety has been challenged for multiple reasons including negligible risk of altering allergen levels compared with traditional non-GM breeding...
July 15, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28719221/biosimilars-biologics-that-meet-patients-needs-and-healthcare-economics
#6
Mark McCamish, William Yoon, James McKay
Biologics have revolutionized medical care, yet uniform access to these effective medicines remains difficult due to the increasing costs of healthcare. As patent exclusivity on the early biologics wanes, regulatory and legal systems are adapting to bring competition to the field in the form of biosimilars. Biosimilars are biologics that offer the same clinical benefit in one or more of the same indications as the reference biologic drug and bring competition to the biologics space. Legislation creating a pathway resulting in the first US approvals of biosimilars has been in place since 2010, but the regulatory methodology and science of evaluating the sameness of two biologics has been in use for decades...
September 2016: American Journal of Managed Care
https://www.readbyqxmd.com/read/28714705/professional-psychology-in-germany-national-socialism-and-the-second-world-war
#7
Wolfgang Schönpflug
Hundreds of positions for psychologists were established after the National Socialists seized power in 1933. It has accordingly been asserted that professional psychology in Germany experienced significant growth during the National Socialist period. An analysis of archival materials and of a recent collection of biographies indicates otherwise, however. German psychology, in fact, declined because of systematic persecution and a surge of emigration, a deficit that subsequent cohorts were barely able to make up until 1945...
July 17, 2017: History of Psychology
https://www.readbyqxmd.com/read/28713068/implementation-of-good-laboratory-practices-glp-in-basic-scientific-research-translating-the-concept-beyond-regulatory-compliance
#8
REVIEW
G B Jena, Sapana Chavan
The principles of Good Laboratory Practices (GLPs) are mainly intended for the laboratories performing studies for regulatory compliances. However, today GLP can be applied to broad disciplines of science to cater to the needs of the experimental objectives, generation of quality data and assay reproducibility. Considering its significance, it can now be applied in academics; industries as well as government set ups throughout the world. GLP is the best way to promote the reliability, reproducibility of the test data and hence facilitates the international acceptability...
July 13, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28713023/an-extended-mathematical-model-of-tumor-growth-and-its-interaction-with-the-immune-system-to-be-used-for-developing-an-optimized-immunotherapy-treatment-protocol
#9
Milad Qomlaqi, Fariba Bahrami, Maryam Ajami, Jamshid Hajati
BACKGROUND: Chemotherapy is usually known as the main modality for cancer treatment. Nevertheless, most of chronic cancers could not be treated with chemotherapy alone. Immunotherapy is a new modality for cancer treatment that is effective for early stages of cancer and it has fewer side effects compared to chemotherapy, specifically for those types of cancer that are resistant to it. METHOD: This work presents an extended mathematical model to depict interactions between cancerous and adaptive immune system in mouse...
July 14, 2017: Mathematical Biosciences
https://www.readbyqxmd.com/read/28712182/trend-of-irrational-medication-among-the-students-of-department-of-pharmacy-abbottabad-university-of-science-and-technology-in-common-cold-and-flu
#10
Mujeeb Ur Rehman, Saif Ullah Mehsud, Sartaj Ali, Muhammad Ishaq, Mumtaz Ali Khan
BACKGROUND: Common cold and flu are mostly of viral pathogenesis with symptoms in upper respiratory tract. It is highly contagious and close inter-individual contact in winter season increase the spread spectrum. Mis-interpretation with bacterial cause leads to irrationality in its medication. METHODS: A cross-sectional study was conducted among pharmacy department students in February-March 2016. Data were collected through self-administered questionnaire and expressed as percentage frequency...
January 2017: Journal of Ayub Medical College, Abbottabad: JAMC
https://www.readbyqxmd.com/read/28711892/3-d-bioprinting-law-regulation-perspectives
#11
Vitalii Pashkov, Andrii Harkusha
INTRODUCTION: Achieved level of technical progress moves us closer and closer to practical use of 3-d bioprinting technologies in real life. Such perspective raise a wide variety of crucial legal issues from the acceptable model of regulation of the science and its' societal effects to problems of the commercialization of the technology and potential restrictions of its use. Some key points on concept of legal regulation of abovementioned sphere is a base of this study. MATERIAL AND METHODS: Scientific discussion on 3-D bioprinting, European Union`s and US experience in patenting of 3-D bioprinting technologies, European Medicine Agency (EMA) or the US Food and Drug Administration (FDA) regulations, European Medical Technology Industry Association (EUCOMED) Acts...
2017: Wiadomości Lekarskie: Organ Polskiego Towarzystwa Lekarskiego
https://www.readbyqxmd.com/read/28690889/imbalances-in-t-cell-related-transcription-factors-among-patients-with-hashimoto-s-thyroiditis
#12
Vahid Safdari, Ebrahim Alijani, Maryam Nemati, Abdollah Jafarzadeh
OBJECTIVES: Imbalances in effector T cell functioning have been associated with a number of autoimmune diseases, including Hashimoto's thyroiditis (HT). Differentiation of effector T helper (Th) 1, Th2, Th17 and regulatory T cell (Treg) lymphocytes is regulated by transcription factors, including Th1-specific T box (T-bet), GATA binding protein-3 (GATA3), retinoid-related orphan receptor (ROR)-α and forkhead box P3 (FOXP3). This study aimed to investigate Th1/Th2, Th1/Treg, Th2/Treg and Th17/Treg balances at the level of these transcription factors...
May 2017: Sultan Qaboos University Medical Journal
https://www.readbyqxmd.com/read/28689746/steps-towards-the-international-regulatory-acceptance-of-non-animal-methodology-in-safety-assessment
#13
Fiona Sewell, John Doe, Nichola Gellatly, Ian Ragan, Natalie Burden
The current animal-based paradigm for safety assessment must change. In September 2016, the UK National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) brought together scientists from regulatory authorities, academia and industry to review progress in bringing new methodology into regulatory use, and to identify ways to expedite progress. Progress has been slow. Science is advancing to make this possible but changes are necessary. The new paradigm should allow new methodology to be adopted once it is developed rather than being based on a fixed set of studies...
July 8, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28689745/itching-for-change-embracing-modern-flea-and-tick-product-development
#14
Katherine Groff, Patricia Bishop
The development and regulatory approval of ectoparasiticides, including flea and tick control products, involves decades-old methods and the use of large numbers of animals to evaluate toxicity and efficacy. Animals also are used to rear (breed and feed) fleas and ticks for later use in testing. Non-animal methods for regulatory-required testing and rearing currently exist and, with further development, others could soon become available. Here we provide an overview of the state-of-the-science of non-animal methods for rearing and regulatory-required efficacy testing of flea and tick control products...
July 6, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28689708/the-growing-role-of-biologics-and-biosimilars-in-the-united-states-perspectives-from-the-apha-biologics-and-biosimilars-stakeholder-conference
#15
Judy Crespi-Lofton, Jann B Skelton
OBJECTIVES: The American Pharmacists Association (APhA) convened the Biologics and Biosimilars Stakeholder Conference on November 30, 2016, in Washington DC. The objectives of the Conference were to determine the key issues and challenges within the marketplace for biologics, follow-on biologics (FOBs), and biosimilars, identify potential roles and responsibilities of pharmacists regarding biologic and biosimilar medications, and identify actions or activities that pharmacists may take to optimize the safe and cost-effective use of biologics and biosimilars...
July 6, 2017: Journal of the American Pharmacists Association: JAPhA
https://www.readbyqxmd.com/read/28684318/the-juvenile-toxicity-study-as-a-tool-for-a-science-based-risk-assessment-in-the-children-population-group
#16
REVIEW
Laura Narciso, Tiziana Catone, Gabriele Aquilina, Leonello Attias, Isabella De Angelis, Maria Grazia Iuliano, Roberta Tassinari, Alberto Mantovani, Francesca Maranghi
Children show unique features concerning chemical hazards and risks, due to different exposure scenarios, age-related metabolic capacity and biological susceptibility linked to post-natal development. Chemical Regulatory frameworks state the need of children risk characterization. Current testing guidelines covering post-natal development are not routinely required by regulatory applications other than pesticides and biocides. Juvenile toxicity studies are foreseen for paediatric drugs: the toxicological repeated-dose tests don't allow accurate evaluations of effects upon direct exposure of immature organism...
July 3, 2017: Reproductive Toxicology
https://www.readbyqxmd.com/read/28681680/evolution-of-chemical-specific-adjustment-factors-csaf-based-on-recent-international-experience-increasing-utility-and-facilitating-regulatory-acceptance
#17
Virunya S Bhat, M E Bette Meek, Mathieu Valcke, Caroline English, Alan Boobis, Richard Brown
The application of chemical-specific toxicokinetic or toxicodynamic data to address interspecies differences and human variability in the quantification of hazard has potential to reduce uncertainty and better characterize variability compared with the use of traditional default or categorically-based uncertainty factors. The present review summarizes the state-of-the-science since the introduction of the World Health Organization/International Programme on Chemical Safety (WHO/IPCS) guidance on chemical-specific adjustment factors (CSAF) in 2005 and the availability of recent applicable guidance including the WHO/IPCS guidance on physiologically-based pharmacokinetic (PBPK) modeling in 2010 as well as the U...
July 6, 2017: Critical Reviews in Toxicology
https://www.readbyqxmd.com/read/28681444/a-call-to-incorporate-systems-theory-and-human-factors-into-the-existing-investigation-of-harm-in-clinical-research-involving-healthcare-products
#18
Bernard Bégaud, Esther Daemen, Ioannis Dokas, Brian Edwards, Jonathan M Fishbein, Howard E Greenberg, Alan Hochberg, Hervé Le Louet, Jytte Lyngvig, Nataliya Mogles, Kathryn Owen, Christine Prendergast, Martin Rejzek, Sofia Trantza, David Webb, Matthew Whalen, Simon Whiteley
This is a joint statement from individual pharmacology and pharmaceutical professionals acting in their own capacity including members of the Alliance for Clinical Research Excellence and Safety (ACRES) and the International Society of Pharmacovigilance (ISoP). By building on the extensive pharmacological and regulatory investigations that already take place, we are calling for a fuller and more robust systems-based approach to the independent investigation of clinical research when serious incidents of harm occur, starting with first-in-human clinical trials...
July 6, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28677675/probabilistic-dietary-risk-assessment-of-pesticide-residues-in-foods-for-the-german-population-based-on-food-monitoring-data-from-2009-to-2014
#19
Christian Sieke, Britta Michalski, Thomas Kuhl
Dietary risks for the German population owing to pesticide residues in foods were assessed based on food monitoring data, consumption surveys for children and adults and compound specific toxicological reference values or general thresholds of toxicological concern. A tiered probabilistic modelling was conducted to screen 700 pesticides for significant long- and short-term dietary exposures. Especially for the short-term dietary exposure, the probabilistic methodology used allows simultaneous consideration of the complete daily consumption, whereas most regulatory bodies still rely on single commodity approaches...
July 5, 2017: Journal of Exposure Science & Environmental Epidemiology
https://www.readbyqxmd.com/read/28668645/herbal-medicinal-products-evidence-and-tradition-from-a-historical-perspective
#20
Robert Jütte, Michael Heinrich, Axel Helmstädter, Jost Langhorst, Günter Meng, Wilhelm Niebling, Tanja Pommerening, Hans J Trampisch
BACKGROUND: Aside from the fully licensed herbal medicines there are products on the European pharmaceutical market which are registered by virtue of their longstanding traditional use. The normal registration procedure does not apply to them because presently they do not meet the legal requirements for a full license as set out in the relevant European Union Directive. One of these requirements, "proof of tradition", has so far been dealt with in different ways and fails to meet the criteria of good practice...
June 29, 2017: Journal of Ethnopharmacology
keyword
keyword
84244
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"