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Quality system regulations

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https://www.readbyqxmd.com/read/28934562/the-enduring-legacy-of-250-years-of-pharmacology-in-edinburgh
#1
John S Kelly, Angus V P Mackay
Two hundred fifty years ago, the University of Edinburgh appointed Francis Home to the first chair of materia medica, the accumulated knowledge of materials used in healing. Francis Home and his colleagues were determined to improve the quality of medical training in Edinburgh by introducing a final examination and compiling a catalog of medicines validated by the Royal College of Physicians of Edinburgh. The catalog, known as the Edinburgh Pharmacopoeia, was a great success, partly due to the orderly nature of its contents, its routine editing to eliminate worthless entries, and the introduction of new treatments whose preparation was precisely documented...
September 13, 2017: Annual Review of Pharmacology and Toxicology
https://www.readbyqxmd.com/read/28933019/effects-of-municipal-solid-waste-and-sewage-sludge-compost-based-growing-media-on-the-yield-and-heavy-metal-content-of-four-lettuce-cultivars
#2
Concetta Eliana Gattullo, Carlo Mininni, Angelo Parente, Francesco Fabiano Montesano, Ignazio Allegretta, Roberto Terzano
Compost has been recently suggested as an alternative to peat for the preparation of growing substrates in soilless cultivation systems. However, some physico-chemical properties of compost may reduce plant performance and endanger the quality of productions, in particular for possible heavy metal accumulation in edible parts. This study aims at evaluating the suitability of a municipal solid waste compost (MSWC) and a sewage sludge compost (SSC) as components of growing media for the soilless cultivation of lettuce (Lactuca sativa L...
September 20, 2017: Environmental Science and Pollution Research International
https://www.readbyqxmd.com/read/28929668/-systematic-review-on-safety-of-sofren-injection
#3
Yi Que, Yan-Ming Xie, Xing Liao, Yi-Li Zhang
This systematic review aims to evaluate the drug safety of sofren injection in clinical studies. Seven databases were retrieved, and the articles were extracted by 2 researchers according to inclusion and exclusion criteria. Then the quality of all studies and extracted information was evaluated. Sixty three articles were finally included in our study, including 58 randomized controlled trials, 3 non randomized controlled trials, and 2 case reports. All studies included 5 872 patients. Intervention group had a total of 23 cases of adverse drug reaction(ADR), accounting for 0...
October 2016: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/28926869/purification-and-characterization-of-the-soluble-form-of-the-receptor-for-advanced-glycation-end-products-srage-a-novel-fast-economical-and-convenient-method
#4
Varun Kumar, Alba Sulaj, Thomas Fleming, Peter P Nawroth
The receptor for advanced glycation end-products (RAGE) is a multi-ligand receptor which belongs to the pattern recognition receptor family and can bind to various ligands such as advanced glycation end-products (AGEs), members of the S100 protein family, glycosaminoglycans, amyloid β peptides, high-mobility group box-1 (HMGB1) and nucleic acids through its extracellular domain. The RAGE-ligand interaction leads to the activation of MAP kinase and NF-kB signaling pathways. Further ligand-induced up-regulation of RAGE is involved in various patho-physiological situations including late diabetic complications, Alzheimer disease and several other neurodegenerative diseases...
September 19, 2017: Experimental and Clinical Endocrinology & Diabetes
https://www.readbyqxmd.com/read/28926587/functional-characterization-of-zebrafish-orthologs-of-the-human-beta-3-glucosyltransferase-b3glct-gene-mutated-in-peters-plus-syndrome
#5
Eric Weh, Hideyuki Takeuchi, Sanaa Muheisen, Robert S Haltiwanger, Elena V Semina
Peters Plus Syndrome (PPS) is a rare autosomal recessive disease characterized by ocular defects, short stature, brachydactyly, characteristic facial features, developmental delay and other highly variable systemic defects. Classic PPS is caused by loss-of-function mutations in the B3GLCT gene encoding for a β3-glucosyltransferase that catalyzes the attachment of glucose via a β1-3 glycosidic linkage to O-linked fucose on thrombospondin type 1 repeats (TSRs). B3GLCT was shown to participate in a non-canonical ER quality control mechanism; however, the exact molecular processes affected in PPS are not well understood...
2017: PloS One
https://www.readbyqxmd.com/read/28925273/-current-trends-in-gamete-donation-psychosocial-and-ethical-issues
#6
T Rumpíková, I Oborná, H Konečná
OBJECTIVE: To overview contemporary knowledge of legal and psychosocial rules in gamete donation. Previously, anonymous donation was preferred and recommended by experts but currently, with respect to the right to know the genetic origin of individuals, the relation to donor anonymity was reconsidered in many countries. There is a growing tendency to introduce the open identity system in gamete donation. Such system may guarantee that the child born after gamete donation may have receive the identification data of the donor of gametes...
2017: Ceská Gynekologie
https://www.readbyqxmd.com/read/28923044/cost-benefit-of-investment-on-quality-in-pharmaceutical-manufacturing-who-gmp-pre-and-post-certification-of-a-nigerian-pharmaceutical-manufacturer
#7
Chimezie Anyakora, Obinna Ekwunife, Faith Alozie, Mopa Esuga, Jonathan Ukwuru, Steve Onya, Jude Nwokike
BACKGROUND: Pharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalification. However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity. This paper primarily evaluates benefits against the cost of investing in GMP, using a Nigerian pharmaceutical company, Chi Pharmaceuticals Limited, as a case study...
September 18, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28922755/root-transcriptomic-responses-of-grafted-grapevines-to-heterogeneous-nitrogen-availability-depend-on-rootstock-genotype
#8
Noé Cochetel, Frédéric Escudié, Sarah Jane Cookson, Zhanwu Dai, Philippe Vivin, Pierre-François Bert, Mindy Stephania Muñoz, Serge Delrot, Christophe Klopp, Nathalie Ollat, Virginie Lauvergeat
In many fruit species, including grapevine, grafting is used to improve scion productivity and quality and to adapt the plant to environmental conditions. However, the mechanisms underlying the rootstock control of scion development are still poorly understood. The ability of rootstocks to regulate nitrogen uptake and assimilation may contribute to this control. A split-root system was used to grow heterografted grapevines and to investigate the molecular responses to changes in nitrate availability of two rootstocks known to affect scion growth differently...
July 10, 2017: Journal of Experimental Botany
https://www.readbyqxmd.com/read/28915951/male-contraception-prospects-for-sound-and-ultrasound
#9
Robert Sewak, Bettina Teng, Lee A Learman, Charles H Hennekens
The worldwide human population growth rate, which doubled during the 20th century, as well as the increasing fertility rate, have contributed to an increasing and evolving emphasis on contraception. With respect to female contraceptive methods, many have been developed, marketed, and are widely available. In contrast, male contraception has been limited to condoms, which pose logistical challenges, and vasectomy, which is largely irreversible. The use of sound to achieve effective and safe male contraception is a promising but unproven hypothesis...
September 2017: Medical Hypotheses
https://www.readbyqxmd.com/read/28915507/ambient-fine-particulate-matters-induce-cell-death-and-inflammatory-response-by-influencing-mitochondria-function-in-human-corneal-epithelial-cells
#10
Eun-Jung Park, Jae-Byoung Chae, Jungmook Lyu, Cheolho Yoon, Sanghwa Kim, Changjoo Yeom, Younghun Kim, Jaerak Chang
Ambient fine particulate matter (AFP) is a main risk factor for the cornea as ultraviolet light. However, the mechanism of corneal damage following exposure to AFP has been poorly understood. In this study, we first confirmed that AFP can penetrate the cornea of mice, considering that two-dimensional cell culture systems are limited in reflecting the situation in vivo. Then, we investigated the toxic mechanism using human corneal epithelial (HCET) cells. At 24h after exposure, AFP located within the autophagosome-like vacuoles, and cell proliferation was clearly inhibited in all the tested concentration...
September 12, 2017: Environmental Research
https://www.readbyqxmd.com/read/28910537/analysis-of-mechanics-of-side-impact-test-defined-in-un-ece-regulation-129
#11
Pawel Baranowski, Krzysztof Damaziak, Lukasz Mazurkiewicz, Jerzy Malachowski, Artur Muszynski, Dario Vangi
OBJECTIVE: This article discusses differences between a side impact procedure described in UN/ECE Regulation 129 and scenarios observed in real world cases. METHODS: Numerical simulations of side impact tests utilizing different boundary conditions are used to compare the severity of the Regulation 129 test and the other tests with different kinematics of child resistant systems (CRS). In the simulations, the authors use a validated finite element (FE) model of real world CRS together with a fully deformable numerical model of the Q3 anthropomorphic test device (ATD) by Humanetics Innovative Solution, Inc...
September 14, 2017: Traffic Injury Prevention
https://www.readbyqxmd.com/read/28906059/benefits-and-limitations-of-dna-barcoding-and-metabarcoding-in-herbal-product-authentication
#12
REVIEW
Ancuta Cristina Raclariu, Michael Heinrich, Mihael Cristin Ichim, Hugo de Boer
INTRODUCTION: Herbal medicines play an important role globally in the health care sector and in industrialised countries they are often considered as an alternative to mono-substance medicines. Current quality and authentication assessment methods rely mainly on morphology and analytical phytochemistry-based methods detailed in pharmacopoeias. Herbal products however are often highly processed with numerous ingredients, and even if these analytical methods are accurate for quality control of specific lead or marker compounds, they are of limited suitability for the authentication of biological ingredients...
September 14, 2017: Phytochemical Analysis: PCA
https://www.readbyqxmd.com/read/28904248/the-system-and-human-resources-for-occupational-health-in-republic-of-indonesia-for-japanese-enterprises-to-manage-proper-occupational-health-activities-at-overseas-workplaces
#13
Ko Hiraoka, Shigeyuki Kajiki, Yuichi Kobayashi, Nuri Purwito Adi, Dewi Sumaryani Soemarko, Masamichi Uehara, Shigemoto Nakanishi, Koji Mori
OBJECTIVES: To consider the appropriate occupational health system for Japanese enterprises in Indonesia with information on the regulations and development of the specialists. METHODS: In this study, we used the information-gathering checklist developed by Kajiki et al. Along with literature and internet surveys, we surveyed local corporations owned and operated by Indonesians, central government agencies in charge of medical and health issues, a Japanese independent administrative agency supporting subsidiaries of overseas Japanese enterprises, and an educational institution formulating specialized occupational physician training curricula...
September 13, 2017: Sangyō Eiseigaku Zasshi, Journal of Occupational Health
https://www.readbyqxmd.com/read/28904021/bap-exposure-causes-oocyte-meiotic-arrest-and-fertilization-failure-to-weaken-female-fertility
#14
Mianqun Zhang, Yilong Miao, Qian Chen, Meng Cai, Wenkang Dong, Xiaoxin Dai, Yajuan Lu, Changyin Zhou, Zhaokang Cui, Bo Xiong
Benzo[a]pyrene (BaP) is a ubiquitous environmental pollutant and carcinogen that is frequently found in particulate matter, with a diameter of ≤2.5 μm (PM2.5). It has been reported to interrupt the normal reproductive system, but the exact molecular basis has not been clearly defined. To understand the underlying mechanisms regarding how BaP exposure disrupts female fertility, we evaluated oocyte quality by assessing the critical regulators and events during oocyte meiotic maturation and fertilization. We found that BaP exposure compromised the mouse oocyte meiotic progression by disrupting normal spindle assembly, chromosome alignment, and kinetochore-microtubule attachment, consequently leading to the generation of aneuploid eggs...
September 13, 2017: FASEB Journal: Official Publication of the Federation of American Societies for Experimental Biology
https://www.readbyqxmd.com/read/28902394/quantity-and-quality-limit-detritivore-growth-mechanisms-revealed-by-ecological-stoichiometry-and-co-limitation-theory
#15
Halvor M Halvorson, Erik Sperfeld, Michelle A Evans-White
Resource quantity and quality are fundamental bottom-up constraints on consumers. Best understood in autotroph-based systems, co-occurrence of these constraints may be common but remains poorly studied in detrital-based systems. Here, we used a laboratory growth experiment to test limitation of the detritivorous caddisfly larvae Pycnopsyche lepida across a concurrent gradient of oak litter quantity (food supply) and quality (phosphorus:carbon, P:C ratios). Growth increased simultaneously with quantity and quality, indicating co-limitation across the resource gradients...
September 13, 2017: Ecology
https://www.readbyqxmd.com/read/28899704/2017-acr-annual-meeting-open-microphone-session-navigating-the-landscape-of-changing-practice-models-private-practice-corporate-radiology-and-enterprise-systems
#16
Eric J Stern, Catherine Everett, Eric B Friedberg, Amy L Kotsenas, McKinley Glover, Johnson B Lightfoote, Neil Lall, Timothy L Swan
Many practice groups are considering adopting new practice models, primarily to secure their practices by adapting to new payment models, government compliance and regulation, and increasing IT and infrastructure costs. As we move toward value-based care and capitation, the value equation (value = quality/cost) will lead us to also compete on cost to improve value. No matter what payment models ultimately dominate, we need to be prepared to lead in a value-based care environment. Measures of value will either be defined by radiologists or imposed by outside entities...
September 9, 2017: Journal of the American College of Radiology: JACR
https://www.readbyqxmd.com/read/28893720/the-case-for-universal-screening-of-private-well-water-quality-in-the-u-s-and-testing-requirements-to-achieve-it-evidence-from-arsenic
#17
Yan Zheng, Sara V Flanagan
BACKGROUND: The 1974 Safe Drinking Water Act (SDWA) regulates >170,000 public water systems to protect health, but not >13 million private wells. State and local government requirements for private well water testing are rare and inconsistent; the responsibility to ensure water safety remains with individual households. Over the last two decades, geogenic arsenic has emerged as a significant public health concern due to high prevalence in many rural American communities. OBJECTIVES: We build the case for universal screening of private well water quality around arsenic, the most toxic and widespread of common private water contaminants...
August 3, 2017: Environmental Health Perspectives
https://www.readbyqxmd.com/read/28889014/transcriptomic-and-morphological-analyses-of-litopenaeus-vannamei-intestinal-barrier-in-response-to-vibrio-paraheamolyticus-infection-reveals-immune-response-signatures-and-structural-disruption
#18
Cancan Qi, Lei Wang, Mei Liu, Keyong Jiang, Mengqiang Wang, Wei Zhao, Baojie Wang
The white shrimp Litopenaeus vannamei has been greatly impacted by Vibrio infection. In this study, we investigated the intestinal barrier response of L vannamei following challenge with Vibrio parahaemolyticus E1, by examining morphological changes and transcriptome expression levels. A total of 16,4420 unigenes were obtained from RNAseq data after quality control and assembly, and 4646 differentially expressed genes (DEGs) were identified following Vibrio challenge, of which 2469 unigenes were significantly up-regulated and 2177 were significantly down-regulated...
September 6, 2017: Fish & Shellfish Immunology
https://www.readbyqxmd.com/read/28888793/metal-bioavailability-in-ecological-risk-assessment-of-freshwater-ecosystems-from-science-to-environmental-management
#19
REVIEW
Kristiina Väänänen, Matti T Leppänen, XuePing Chen, Jarkko Akkanen
Metal contamination in freshwater ecosystems is a global issue and metal discharges to aquatic environments are monitored in order to protect aquatic life and human health. Bioavailability is an important factor determining metal toxicity. In aquatic systems, metal bioavailability depends on local water and sediment characteristics, and therefore, the risks are site-specific. Environmental quality standards (EQS) are used to manage the risks of metals in aquatic environments. In the simplest form of EQSs, total concentrations of metals in water or sediment are compared against pre-set acceptable threshold levels...
September 7, 2017: Ecotoxicology and Environmental Safety
https://www.readbyqxmd.com/read/28884424/immunobiology-of-spinal-cord-injuries-and-potential-therapeutic-approaches
#20
REVIEW
Aabra Ahmed, Arun-Angelo Patil, Devendra K Agrawal
The incidence of spinal cord injuries (SCI) is high every year. As the spinal cord is the highway that allows for the brain to control the rest of the body, spinal cord injuries greatly impact the quality of life of the patients. The SCI include the primary response consisting of the initial accident-induced damage and the secondary response that is characterized by damage due to inflammation and biological responses. Astrocytes are the first to act at the site of the injury, forming a glial scar and attracting immune cells...
September 7, 2017: Molecular and Cellular Biochemistry
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