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https://www.readbyqxmd.com/read/28342844/a-system-dynamics-modelling-approach-to-assess-the-impact-of-launching-a-new-nicotine-product-on-population-health-outcomes
#1
Andrew Hill, Oscar M Camacho
In 2012 the US FDA suggested the use of mathematical models to assess the impact of releasing new nicotine or tobacco products on population health outcomes. A model based on system dynamics methodology was developed to project the potential effects of a new nicotine product at a population level. A model representing traditional smoking populations (never, current and former smokers) and calibrated using historical data was extended to a two-product model by including electronic cigarettes use statuses. Smoking mechanisms, such as product initiation, switching, transition to dual use, and cessation, were represented as flows between smoking statuses (stocks) and the potential effect of smoking renormalisation through a feedback system...
March 22, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28342579/magnetic-mini-mover-procedure-for-pectus-excavatum-iv-fda-sponsored-multicenter-trial
#2
Claire E Graves, Shinjiro Hirose, Gary W Raff, Corey W Iqbal, Jill Imamura-Ching, Darrell Christensen, Richard Fechter, Dillon Kwiat, Michael R Harrison
PURPOSE: The Magnetic Mini-Mover Procedure (3MP) is a minimally invasive treatment for prepubertal patients with pectus excavatum. This multicenter trial sought to supplement safety and efficacy data from an earlier pilot trial. METHODS: Fifteen patients with pectus excavatum had a titanium-enclosed magnet implanted on the sternum. Externally, patients wore a custom-fitted magnetic brace. Patients were monitored closely for safety. Efficacy was determined by the Haller Index (HI) and satisfaction surveys...
March 15, 2017: Journal of Pediatric Surgery
https://www.readbyqxmd.com/read/28340378/current-fda-approved-treatments-for-non-small-cell-lung-cancer-and-potential-biomarkers-for-its-detection
#3
REVIEW
Karla A Ruiz-Ceja, Yolanda I Chirino
BACKGROUND: Lung cancer is the leading worldwide cancer with almost 1.5 million deaths every year. Some drugs for lung cancer treatment have been available on the market for decades, but novel drugs have emerged promising better outcomes, especially for Non-Small Cell Lung Cancer (NSCLC), which represents 75% of lung cancer cases. However, how much do drugs have evolved for NSCLC treatment? Are they sharing the same mechanism of action? AIM: In this review we analyzed how the approved drugs by Federal Drug Agency for NSCLC have advanced in the last four decades identifying shared mechanism of action of medicines against NSCLC treatment and some of the potential biomarkers for early detection...
March 21, 2017: Biomedicine & Pharmacotherapy, Biomédecine & Pharmacothérapie
https://www.readbyqxmd.com/read/28340300/synthesis-of-3-o-sulfated-oligosaccharides-to-understand-the-relationship-between-structures-and-functions-of-heparan-sulfate
#4
Zhangjie Wang, Po-Hung Hsieh, Yongmei Xu, David Thieker, Evangeline Juan En Chai, Shaoshuai Xie, Brian Cooley, Robert Woods, Lianli Chi, Jian Liu
The sulfation at the 3-OH position of glucosamine is an important modification in forming structural domains for heparan sulfate to enable its biological functions. Seven 3-O-sulfotransferase isoforms in the human genome are involved in the biosynthesis of 3-O-sulfated heparan sulfate. As a rare modification present in heparan sulfate, the availability of 3-O-sulfated oligosaccharides is very limited. Here, we report the use of a chemoenzymatic synthetic approach to synthesize six 3-O-sulfated oligosaccharides, including three hexasaccharides and three octasaccharides...
March 24, 2017: Journal of the American Chemical Society
https://www.readbyqxmd.com/read/28340111/assessment-of-patient-reported-outcome-instruments-to-assess-chronic-low-back-pain
#5
Abhilasha Ramasamy, Mona L Martin, Steven I Blum, Hiltrud Liedgens, Charles Argoff, Rainer Freynhagen, Mark Wallace, Kelly P McCarrier, Donald M Bushnell, Noël V Hatley, Donald L Patrick
Objective. : To identify patient-reported outcome (PRO) instruments that assess chronic low back pain (cLBP) symptoms (specifically pain qualities) and/or impacts for potential use in cLBP clinical trials to demonstrate treatment benefit and support labeling claims. Design. : Literature review of existing PRO measures. Methods. : Publications detailing existing PRO measures for cLBP were identified, reviewed, and summarized. As recommended by the US Food & Drug Administration (FDA) PRO development guidance, standard measurement characteristics were reviewed, including development history, psychometric properties (validity and reliability), ability to detect change, and interpretation of observed changes...
March 6, 2017: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/28339805/design-and-evaluation-of-a-pharmacogenomics-information-resource-for-pharmacists
#6
Katrina M Romagnoli, Richard D Boyce, Philip E Empey, Yifan Ning, Solomon Adams, Harry Hochheiser
Objective: To develop and evaluate a pharmacogenomics information resource for pharmacists. Materials and Methods: We built a pharmacogenomics information resource presenting Food and Drug Administration (FDA) drug product labelling information, refined it based on feedback from pharmacists, and conducted a comparative usability evaluation, measuring task completion time, task correctness and perceived usability. Tasks involved hypothetical clinical situations requiring interpretation of pharmacogenomics information to determine optimal prescribing for specific patients...
February 26, 2017: Journal of the American Medical Informatics Association: JAMIA
https://www.readbyqxmd.com/read/28339697/are-informed-policies-in-place-to-promote-safe-and-usable-ehrs-a-cross-industry-comparison
#7
Erica L Savage, Rollin J Fairbanks, Raj M Ratwani
Objective: Despite federal policies put in place by the Office of the National Coordinator (ONC) to promote safe and usable electronic health record (EHR) products, the usability of EHRs continues to frustrate providers and have patient safety implications. This study sought to compare government policies on usability and safety, and methods of examining compliance to those policies, across 3 federal agencies: the ONC and EHRs, the Federal Aviation Administration (FAA) and avionics, and the Food and Drug Administration (FDA) and medical devices...
February 19, 2017: Journal of the American Medical Informatics Association: JAMIA
https://www.readbyqxmd.com/read/28339669/in-their-own-words-young-adults-menthol-cigarette-initiation-perceptions-experiences-and-regulation-perspectives
#8
Olivia A Wackowski, Kiameesha R Evans, Melissa B Harrell, Alexandra Loukas, M Jane Lewis, Cristine D Delnevo, Cheryl L Perry
Background: Menthol cigarettes are disproportionately used by young people and have been called smoking starter products. However, limited qualitative research exists on young adults' perceptions of and experiences with these products, with much of it based on document reviews of the tobacco industry's research. Methods: We conducted six focus groups with young adult (ages 18-24) menthol smokers in New Jersey (half with black smokers) between December 2014 and March 2015...
February 17, 2017: Nicotine & Tobacco Research: Official Journal of the Society for Research on Nicotine and Tobacco
https://www.readbyqxmd.com/read/28339529/fda-approval-of-extended-release-oxycodone-for-children-with-severe-pain-a-step-forward
#9
Xiulu Ruan, Srinivas Chiravuri, Alan D Kaye
No abstract text is available yet for this article.
October 20, 2016: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/28339349/is-triclosan-a-neurotoxic-agent
#10
Joanna A Ruszkiewicz, Shaojun Li, Maliya B Rodriguez, Michael Aschner
Triclosan (TCS) is an antibacterial agent that has been used in many products since 1960s. Given its broad usage as an antiseptic TCS is present ubiquitously in the environment. Trace levels of TCS continue to be detected in many organisms, and it has been shown to be particularly toxic to aquatic species. The mechanisms underlying TCS-mediated toxicity include hormone dyshomeostasis, induction of oxidative stress, apoptosis and inflammation. Although TCS has been considered to be non-toxic to mammals, the adverse effects of continuous, long-term and low concentration exposure remain unknown...
2017: Journal of Toxicology and Environmental Health. Part B, Critical Reviews
https://www.readbyqxmd.com/read/28339323/media-coverage-of-fda-drug-safety-communications-about-zolpidem-a-quantitative-and-qualitative-analysis
#11
Steve Woloshin, Lisa M Schwartz, Sara Dejene, Paula Rausch, Gerald J Dal Pan, Esther H Zhou, Aaron S Kesselheim
FDA issues Drug Safety Communications (DSCs) to alert health care professionals and the public about emerging safety information affecting prescription and over-the-counter drugs. News media may amplify DSCs, but it is unclear how DSC messaging is transmitted through the media. We conducted a content analysis of the lay media coverage reaching the broadest audience to characterize the amount and content of media coverage of two zolpidem DSCs from 2013. After the first DSC, zolpidem news stories increased from 19 stories/week in the preceding 3 months to 153 following its release...
March 24, 2017: Journal of Health Communication
https://www.readbyqxmd.com/read/28338324/studies-to-examine-potential-tolerability-differences-between-the-5-ht2c-receptor-selective-agonists-lorcaserin-and-cp-809101
#12
Guy A Higgins, Leonardo B Silenieks, Amy Patrick, Ines A M De Lannoy, Paul J Fletcher, Linda A Parker, Neil J MacLusky, Laura C Sullivan, Teresa A Chavera, Kelly A Berg
Lorcaserin (LOR) is a selective 5-HT2C receptor agonist that has been FDA approved as a treatment for obesity. The most frequently reported side-effects of LOR include nausea and headache, which can be dose limiting. We have previously reported that in the rat, while LOR produced unconditioned signs characteristic of nausea/malaise, the highly selective 5-HT2C agonist CP-809101 (CP) produced fewer equivalent signs. Because this may indicate a subclass of 5-HT2C agonists having better tolerability, the present studies were designed to further investigate this apparent difference...
March 24, 2017: ACS Chemical Neuroscience
https://www.readbyqxmd.com/read/28337975/a-chemical-chaperone-improves-muscle-function-in-mice-with-a-ryr1-mutation
#13
Chang Seok Lee, Amy D Hanna, Hui Wang, Adan Dagnino-Acosta, Aditya D Joshi, Mark Knoblauch, Yan Xia, Dimitra K Georgiou, Jianjun Xu, Cheng Long, Hisayuki Amano, Corey Reynolds, Keke Dong, John C Martin, William R Lagor, George G Rodney, Ergun Sahin, Caroline Sewry, Susan L Hamilton
Mutations in the RYR1 gene cause severe myopathies. Mice with an I4895T mutation in the type 1 ryanodine receptor/Ca(2+) release channel (RyR1) display muscle weakness and atrophy, but the underlying mechanisms are unclear. Here we show that the I4895T mutation in RyR1 decreases the amplitude of the sarcoplasmic reticulum (SR) Ca(2+) transient, resting cytosolic Ca(2+) levels, muscle triadin content and calsequestrin (CSQ) localization to the junctional SR, and increases endoplasmic reticulum (ER) stress/unfolded protein response (UPR) and mitochondrial ROS production...
March 24, 2017: Nature Communications
https://www.readbyqxmd.com/read/28337384/topoisomerase-i-top1-a-major-target-of-fl118-for-its-antitumor-efficacy-or-mainly-involved-in-its-side-effects-of-hematopoietic-toxicity
#14
EDITORIAL
Fengzhi Li, Xiang Ling, Danni L Harris, Jianqun Liao, Yuping Wang, David Westover, Guohui Jiang, Bo Xu, Patrick M Boland, Chunyang Jin
FL118 is a novel camptothecin (CPT) analogue that possesses exceptional antitumor efficacy in human tumor animal models. To date, two CPT analogues, irinotecan and topotecan, have been approved by the FDA for cancer treatment. FL118 exhibits superior antitumor activity over irinotecan and topotecan, and effectively overcomes the irinotecan- or topotecan-resistant human tumors in animal models. Accordingly, FL118 selectively inhibits the expression of multiple cancer-associated proteins (survivin, Mcl-1, XIAP, cIAP2, MdmX)...
2017: American Journal of Cancer Research
https://www.readbyqxmd.com/read/28337317/structural-requirements-of-hdac-inhibitors-saha-analogues-modified-at-the-c2-position-display-hdac6-8-selectivity
#15
Ahmed T Negmeldin, Geetha Padige, Anton V Bieliauskas, Mary Kay H Pflum
Histone deacetylase (HDAC) proteins are epigenetic regulators that deacetylate protein substrates, leading to subsequent changes in cell function. HDAC proteins are implicated in cancers, and several HDAC inhibitors have been approved by the FDA as anticancer drugs, including SAHA (suberoylanilide hydroxamic acid; Vorinostat and Zolinza). Unfortunately, SAHA inhibits most HDAC isoforms, which limits its use as a pharmacological tool and may lead to side effects in the clinic. In this work SAHA analogues substituted at the C2 position were synthesized and screened for HDAC isoform selectivity in vitro and in cells...
March 9, 2017: ACS Medicinal Chemistry Letters
https://www.readbyqxmd.com/read/28336806/fluorouracil-enhances-photodynamic-therapy-of-squamous-cell-carcinoma-via-a-p53-independent-mechanism-that-increases-protoporphyrin-ix-levels-and-tumor-cell-death
#16
Sanjay Anand, Kishore R Rollakanti, Niokelta Brankov, Douglas E Brash, Tayyaba Hasan, Edward V Maytin
Photodynamic therapy (PDT), using 5-aminolevulinic acid (ALA) to drive synthesis of protoporphryin IX (PpIX) is a promising, scar-free alternative to surgery for skin cancers, including squamous cell carcinoma (SCC) and SCC precursors called actinic keratoses (AK). In the United States, PDT is only FDA approved for treatment of AK; this narrow range of indications could be broadened if PDT efficacy were improved. Toward that goal, we developed a mechanism-based combination approach using 5-fluorouracil (5-FU) as a neoadjuvant for ALA-based PDT...
March 23, 2017: Molecular Cancer Therapeutics
https://www.readbyqxmd.com/read/28336789/percutaneous-therapy-for-tricuspid-regurgitation-a-new-frontier-for-interventional-cardiology
#17
Samir R Kapadia, Amar Krishnaswamy, E Murat Tuzcu
Functional tricuspid regurgitation (FTR) is common, whether in association with mitral or aortic valve disease or presenting as an isolated valvular disease. Several studies have shown that TR is associated with poor patient outcomes, though a cause-and-effect relationship of TR to mortality has not been proven. Similarly the impact of surgical treatment of TR on outcomes needs well-controlled randomized trials that are under planning. The current professional society guidelines for treatment of TR are based on expert opinions with a level of evidence C for all indications...
March 23, 2017: Circulation
https://www.readbyqxmd.com/read/28336782/functional-imaging-signature-of-patients-presenting-with-polycythemia-paraganglioma-syndromes
#18
Ingo Janssen, Clara Chi Chen, Zhenping Zhuang, Corina M Millo, Katherine Wolf, Alexander Ling, Frank I Lin, Karen T Adams, Peter Herscovitch, Richard A Feelders, Antonio T Fojo, David Taieb, Electron Kebebew, Karel Pacak
Rationale: Pheochromocytoma/paraganglioma (PPGL) syndromes associated with polycythemia have previously been described in association with mutations in the von Hippel-Lindau (VHL) gene. Recently, mutations in the prolyl hydroxylase gene (PHD) 1 and 2 and in the hypoxia-inducible factor 2 alpha (HIF2A) were also found to be associated with multiple and recurrent PPGL. Such patients also presented with PPGL and polycythemia, and later on, some presented with duodenal somatostatinoma. In additional patients presenting with PPGL and polycythemia, no further mutations have been discovered...
March 23, 2017: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
https://www.readbyqxmd.com/read/28336749/fda-outlines-conditions-for-pharmacies-to-repackage-drug-products
#19
Cheryl A Thompson
No abstract text is available yet for this article.
April 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28336368/novel-strategies-in-the-oral-delivery-of-antidiabetic-peptide-drugs-insulin-glp-1-and-its-analogs
#20
REVIEW
Ruba Ismail, Ildikó Csóka
As diabetes is a complex disorder being a major cause of mortality and morbidity in epidemic rates, continuous research has been done on new drug types and administration routes. Up to now, a large number of therapeutic peptides have been produced to treat diabetes including insulin, glucagon-like peptide-1 (GLP-1) and its analogs. The most common route of administration of these antidiabetic peptides is parenteral. Due to several drawbacks associated with this invasive route, delivery of these antidiabetic peptides by the oral route has been a goal of pharmaceutical technology for many decades...
March 21, 2017: European Journal of Pharmaceutics and Biopharmaceutics
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