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https://www.readbyqxmd.com/read/28729910/drug-induced-gingival-hyperplasia-a-retrospective-study-using-spontaneous-reporting-system-databases
#1
Haruna Hatahira, Junko Abe, Yuuki Hane, Toshinobu Matsui, Sayaka Sasaoka, Yumi Motooka, Shiori Hasegawa, Akiho Fukuda, Misa Naganuma, Tomofumi Ohmori, Yasutomi Kinosada, Mitsuhiro Nakamura
BACKGROUND: Drug-induced gingival hyperplasia (DIGH) causes problems with chewing, aesthetics, and pronunciation, and leads to the deterioration of the patient's quality of life (QOL). Thus, the aim of this study was to evaluate the incidence of DIGH using spontaneous reporting system (SRS) databases. METHODS: We analyzed reports of DIGH from SRS databases and calculated the reporting odds ratios (RORs) of suspected drugs (immunosuppressants, calcium channel blockers, and anticonvulsants)...
2017: Journal of Pharmaceutical Health Care and Sciences
https://www.readbyqxmd.com/read/28724335/exploring-the-potential-for-using-drug-indications-to-prevent-look-alike-and-sound-alike-drug-errors
#2
Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio, Saad Alqahtani, Gordon Schiff
BACKGROUND: Look-alike, sound-alike (LASA) drug names are a cause of medication errors with resulting patient harm and healthcare costs. This study assessed to which extent the use of the generic drug name, therapeutic class, health problem, and the U.S. Food and Drug Administration (FDA)-approved indications might be used to differentiate LASA drug pairs. RESEARCH DESIGN AND METHODS: We collected information about LASA drug pairs reported by the FDA to have look-alike sound-alike similarities...
July 20, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28711892/3-d-bioprinting-law-regulation-perspectives
#3
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/28705006/best-practices-for-the-treatment-of-metastatic-pancreatic-adenocarcinoma-the-therapeutic-landscape-in-2017
#4
Pelin Cinar, Andrew H Ko
The vast majority of patients diagnosed with pancreatic adenocarcinoma have inoperable, most commonly metastatic, disease at the time of initial presentation, at which point systemic therapy becomes the mainstay of treatment. Although survival rates remain very poor in this clinical setting, patients currently have a greater number of therapeutic options available to them than ever before, and consequently individuals are more frequently able to be sequenced through multiple lines of treatment. In this review, we will provide an overview of the current treatment landscape for metastatic pancreatic cancer in 2017, focusing on best practices and the various factors that should be considered in selecting the most appropriate regimen for a given individual...
June 2017: Chinese Clinical Oncology
https://www.readbyqxmd.com/read/28675919/composite-and-multicomponent-end-points-in-clinical-trials
#5
Abdul J Sankoh, Haihong Li, Ralph B D'Agostino
In January 2017, the FDA released the draft guidance to industry on multiple end points in clinical trials. A class of multiplicity problems arise from the testing of individual or subset of components of a composite or multicomponent end point. This commentary attempts to further clarify these problems. Discussions include general consideration on the use of the composite and multicomponent end points, situations when multiplicity adjustments are needed, and the relevant multiple testing methods. Copyright © 2017 John Wiley & Sons, Ltd...
July 4, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28673647/regulation-and-device-development-tips-for-optimizing-your-experience-with-the-food-and-drug-administration
#6
Steven S Brooks
Physician-inventors are in a unique position to identify unserved patient needs, and innovate solutions to clinical problems. These solutions may also have associated commercial opportunities. The logistics of developing these medical products, however, can seem a daunting task. One of the primary barriers in the United States is the regulatory process of the Food and Drug Administration (FDA). In this article, we will explore the risk-based approach used by the FDA which forms a framework to consider the regulatory pathway and the process to gain regulatory clearance or approval for medical devices...
June 2017: Techniques in Vascular and Interventional Radiology
https://www.readbyqxmd.com/read/28673602/platelet-rich-plasma-as-a-minimally-invasive-approach-to-uterine-prolapse
#7
E L Chrysanthopoulou, V Pergialiotis, D Perrea, S Κourkoulis, C Verikokos, S K Doumouchtsis
Pelvic organ prolapse (POP) is a major health problem that affects many women with potentially severe physical and psychological impact as well as impact on their daily activities, and quality of life. Several surgical techniques have been proposed for the treatment of POP. The FDA has published documents that refer to concerns about the use of synthetic meshes for the treatment of prolapse, in view of the severe complications that may occur. These led to hesitancy in use of these meshes and partial increase in use of other biological grafts such as allografts and xenografts...
July 2017: Medical Hypotheses
https://www.readbyqxmd.com/read/28661408/a-note-from-the-editor-duchenne-muscular-dystrophy-genetics-the-fda-and-drug-pricing
#8
Mark Terry
DMD is a muscle-wasting disease. It is caused by mutations in the dystrophin gene which is found on the X chromosome. It has an X-linked recessive inheritance pattern and is passed on by the mother (carrier). It is a progressive disease that usually causes death in early adulthood-often in the 20s, although there have been improvements in treatment, so some patients make it into their 30s and occasionally 40s. In addition to the muscle wasting aspects, serious complications include heart or respiratory-related problems...
2017: Journal of the Association of Genetic Technologists
https://www.readbyqxmd.com/read/28660517/dynamic-water-quality-evaluation-based-on-fuzzy-matter-element-model-and-functional-data-analysis-a-case-study-in-poyang-lake
#9
Bing Li, Guishan Yang, Rongrong Wan, Georg Hörmann
Comprehensively evaluating water quality with a single method alone is challenging because water quality evaluation involves complex, uncertain, and fuzzy processes. Moreover, water quality evaluation is limited by finite water quality monitoring that can only represent water quality conditions at certain time points. Thus, the present study proposed a dynamic fuzzy matter-element model (D-FME) to comprehensively and continuously evaluate water quality status. D-FME was first constructed by introducing functional data analysis (FDA) theory into a fuzzy matter-element model and then validated using monthly water quality data for the Poyang Lake outlet (Hukou) from 2011 to 2012...
June 28, 2017: Environmental Science and Pollution Research International
https://www.readbyqxmd.com/read/28650707/a-review-of-radiation-countermeasures-focusing-on-injury-specific-medicinals-and-regulatory-approval-status-part-i-radiation-sub-syndromes-animal-models-and-fda-approved-countermeasures
#10
Vijay K Singh, Thomas M Seed
PURPOSE: The increasing global risk of nuclear and radiological accidents or attacks has driven renewed research interest in developing medical countermeasures to potentially injurious exposures to acute irradiation. Clinical symptoms and signs of a developing acute radiation injury, i.e. the acute radiation syndrome, are grouped into three sub-syndromes named after the dominant organ system affected, namely the hematopoietic, gastrointestinal, and neurovascular systems. The availability of safe and effective countermeasures against the above threats currently represents a significant unmet medical need...
June 26, 2017: International Journal of Radiation Biology
https://www.readbyqxmd.com/read/28625557/-more-than-3-hours-and-less-than-3-years-safety-of-anaesthetic-procedures-in-infants-less-than-3-years-old-subected-to-surgery-for-more-the-3-hours
#11
Julián Álvarez Escudero, Rosa María Paredes Esteban, Francisco José Cambra Lasaosa, Máximo Vento, Maite López Gil, Juan Carlos de Agustín Asencio, María Teresa Moral Pumarega
An FDA alert in December 2016 on the safety of general anesthesia and sedations in patients less than 3 years of age and pregnant women has raised doubts in relation to the attitude that professionals implicated in these procedures should adopt in relation to these specific group of patients. Confronted with this situation, the following medical scientific societies: Sociedad Española de Anestesia y Reanimación (SEDAR), Sociedad Española de Cirugía Pediátrica (SECP), Sociedad Española de Cuidados Intensivos Pediátricos (SECIP) y Sociedad Española de Neonatología (SENeo), have established a working group to analyze and clarify the safety of these techniques...
June 15, 2017: Anales de Pediatría: Publicación Oficial de la Asociación Española de Pediatría (A.E.P.)
https://www.readbyqxmd.com/read/28618340/fast-and-efficient-zirconia-based-reversed-phase-chromatography-for-selective-determination-of-triptans-in-rat-plasma
#12
Sameh Ahmed, Noha N Atia
Selective and fast chromatographic method was essential for the determination of triptans, selective serotonin receptor (5-HT1) agonists, in biological specimens. However, selective chromatographic separation of these highly basic drugs is a challenging problem on silica-based stationary phases. Zirconia-based stationary phases have been introduced as an efficient alternative for silica-based columns offering unique stability, selectivity, and retention ability for various classes of drugs. Herein, a new selective, fast and reproducible high performance liquid chromatographic method (HPLC) was developed and validated for the determination of four triptans in plasma samples namely; Sumatriptan (SMT), Zolmitriptan (ZLT), Eletriptan (ELT) and Rizatriptan (RZT)...
September 5, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28616097/updated-report-on-tools-to-measure-outcomes-of-clinical-trials-in-fragile-x-syndrome
#13
REVIEW
Dejan B Budimirovic, Elizabeth Berry-Kravis, Craig A Erickson, Scott S Hall, David Hessl, Allan L Reiss, Margaret K King, Leonard Abbeduto, Walter E Kaufmann
OBJECTIVE: Fragile X syndrome (FXS) has been the neurodevelopmental disorder with the most active translation of preclinical breakthroughs into clinical trials. This process has led to a critical assessment of outcome measures, which resulted in a comprehensive review published in 2013. Nevertheless, the disappointing outcome of several recent phase III drug trials in FXS, and parallel efforts at evaluating behavioral endpoints for trials in autism spectrum disorder (ASD), has emphasized the need for re-assessing outcome measures and revising recommendations for FXS...
2017: Journal of Neurodevelopmental Disorders
https://www.readbyqxmd.com/read/28593780/-complications-tension-free-vaginal-tape-surgery
#14
P Piškytlová
OBJECTIVE: A comprehensive overview of the potential complications associated with vaginal tape operations, which are commonly used in the treatment of stress urinary incontinence in women. DESIGN: Review article. SETTING: Department of Obstetrics and Gynecology, Oblastní nemocnice Kolín, a.s. METHODS: Using medical databases were searched articles dealing with complications tension-free vaginal tape procedures. In individual cases, complications were observed their causes and solutions...
2017: Ceská Gynekologie
https://www.readbyqxmd.com/read/28583106/prescription-drug-use-during-pregnancy-in-southern-tigray-region-north-ethiopia
#15
Fantahun Molla, Admassu Assen, Solomon Abrha, Birhanetensay Masresha, Arega Gashaw, Abrham Wondimu, Yared Belete, Wondim Melkam
BACKGROUND: Judicious utilization of drugs rescues the fetus from the harmful effects while treating the health problems of the pregnant women. This study aimed at evaluating drug utilization pattern and its associated factors among pregnant women in Southern Tigray, Ethiopia. METHOD: Institution based cross-sectional study was conducted among 647 pregnant women who had been attending obstetrics-gynecology and antenatal care units in different health facilities of Southern Tigray region...
June 5, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28571554/methotrexate-in-the-treatment-of-psoriasis-and-rheumatoid-arthritis-mechanistic-insights-current-issues-and-novel-delivery-approaches
#16
P Rajitha, Raja Biswas, M Sabitha, R Jayakumar
Our review is focused on the use of methotrexate in drug therapy of two autoimmune diseases, psoriasis and rheumatoid arthritis (RA). The article describes the pathogenesis of psoriasis and RA, the role of methotrexate in the treatment of these diseases with more focused review on the mechanism behind the clinical benefits of methotrexate therapy. Methotrexate due to its cytotoxic, anti-inflammatory and immune modulatory activities provides clinical benefits in the therapy of the selected diseases. This review also gives a panorama of the problems associated with the use of methotrexate in the selected diseases and the guidelines provided by FDA for its safe use...
May 31, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28566572/importance-of-reverse-translational-research-rtr
#17
Yuichi Sugiyama
 When events lead to clinical problems, the mechanisms involved often remain unclear. This is true for medications and therapies, in addition to problems inherent in an underlying disease. However, the recent development of modeling and metric methods makes it possible to estimate the relationship between side effects and various factors to explain inter-individual differences, such as genetic polymorphisms, co-administered drugs, age, gender, dysfunction of the liver/kidney based upon the database for side effects [such as Food and Drug Administration-Adverse Event Reporting System (FDA-AERS)] and the database in a patient's medical records...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28541222/drug-target-prediction-by-multi-view-low-rank-embedding
#18
Limin Li, Menglan Cai
Drug repositioning has been a key problem in drug development, and heterogeneous data sources are used to predict drug-target interactions by different approaches. However, most of studies focus on a single representation of drugs or proteins. It has been shown that integrating multi-view representations of drugs and proteins can strengthen the prediction ability. For example, a drug can be represented by its chemical structure, or by its chemical response in different cells. A protein can be represented by its sequence, or by its gene expression values in different cells...
May 18, 2017: IEEE/ACM Transactions on Computational Biology and Bioinformatics
https://www.readbyqxmd.com/read/28538203/uhplc-ms-ms-method-with-sample-dilution-to-test-therapeutic-adherence-through-quantification-of-ten-antihypertensive-drugs-in-urine-samples
#19
Amedeo De Nicolò, Valeria Avataneo, Franco Rabbia, Mauro Sciandra, Francesco Tosello, Jessica Cusato, Elisa Perlo, Paolo Mulatero, Franco Veglio, Giovanni Di Perri, Antonio D'Avolio
Nowadays, hypertension represents an important health problem, particularly in developed countries. In some cases the standard therapeutic approaches are not able to reestablish the normal blood pressure values: this condition is called "resistant hypertension". However, a fraction of cases of resistant hypertension are actually due to poor adherence to the prescribed therapy. Therapeutic Drug Monitoring could represent a direct and useful tool to correctly identify non-compliant patients. Nevertheless, high throughput methods for the simultaneous monitoring of a wide panel of drugs in the same analysis are lacking and, furthermore, there is not a generally acknowledged "standard" matrix for this test (plasma or urine)...
May 13, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28533089/synergistic-anti-tumor-effects-of-bevacizumab-and-tumor-targeted-polymerized-vegf-sirna-nanoparticles
#20
Myung Goo Kim, Sung Duk Jo, Ji Young Yhee, Beom Suk Lee, So Jin Lee, Sung Gurl Park, Sun-Woong Kang, Sun Hwa Kim, Ji Hoon Jeong
A variety of VEGF inhibitors have been reported to treat cancers by suppressing tumor angiogenesis. Bevacizumab, a monoclonal VEGF antibody, was the first FDA approved anti-angiogenic agent for cancer treatments. However, bevacizumab shows modest therapeutic efficiency and often cause resistant problem in significant populations of cancer patients. To solve these problem, we investigated the therapeutic efficacy of siRNA drugs targeting VEGF and combination of the RNAi drug with bevacizumab for cancer treatments...
July 15, 2017: Biochemical and Biophysical Research Communications
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