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https://www.readbyqxmd.com/read/28654780/development-and-validation-of-an-icp-ms-method-for-the-determination-of-elemental-impurities-in-tp-6076-active-pharmaceutical-ingredient-api-according-to-usp-%C3%A2-232%C3%A2-%C2%AA-%C3%A2-233%C3%A2-%C2%AA
#1
Osama Chahrour, John Malone, Mark Collins, Vrushali Salmon, Catherine Greenan, Amy Bombardier, Zhongze Ma, Nick Dunwoody
The new guidelines of the United States pharmacopeia (USP), European pharmacopeia (EP) and international conference on harmonization (ICH) regulating elemental impurities limits in pharmaceuticals signify the end of unspecific analysis of metals as outlined in USP 〈231〉. The new guidelines specify both daily doses and concentration/limits of elemental impurities in pharmaceutical final products, active pharmaceutical ingredients (API) and excipients. In chapter USP 〈233〉 method implementation, validation and quality control during the analytical process are described...
June 20, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28651650/ethics-review-of-studies-during-public-health-emergencies-the-experience-of-the-who-ethics-review-committee-during-the-ebola-virus-disease-epidemic
#2
Emilie Alirol, Annette C Kuesel, Maria Magdalena Guraiib, Vânia Dela Fuente-Núñez, Abha Saxena, Melba F Gomes
BACKGROUND: Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee (WHO-ERC) was heavily involved in reviews and ethics discussions...
June 26, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28649902/implementation-of-telehealth-is-associated-with-improved-timeliness-to-kidney-transplant-waitlist-evaluation
#3
Rachel C Forbes, Kristy Kummerow Broman, Tommy B Johnson, Diane B Rybacki, Angela E Hannah Gillis, Margarethe Hagemann Williams, David Shaffer, Irene D Feurer, Douglas A Hale
Introduction The United States Department of Veterans Affairs (VA) National Transplant Program has made efforts to improve access by introducing Web-based referrals and telehealth. The aims of this study were to describe the programmatic implementation and evaluate the effectiveness of new technology on the timeliness to kidney transplant evaluation at a VA medical centre. Methods Between 1 January 2009 and 31 May 2016, 835 patients were approved for evaluation. Monthly data were summarized as: number of applications, median days to evaluation, and median percentage of evaluations that occurred within 30 days...
January 1, 2017: Journal of Telemedicine and Telecare
https://www.readbyqxmd.com/read/28649317/inclusion-of-sex-and-gender-in-biomedical-research-survey-of-clinical-research-proposed-at-the-university-of-pennsylvania
#4
Anne Freeman, Patrick Stanko, Lily N Berkowitz, Neanta Parnell, Anastasia Zuppe, Tracy L Bale, Tracy Ziolek, C Neill Epperson
BACKGROUND: The 2015 National Institutes of Health (NIH) policy that sex be considered as a biological variable (SABV) is now a critical part of the peer-review process for NIH funding as well as publication in several high-impact scientific journals. We sought to determine the degree to which biomedical researchers at the University of Pennsylvania already consider SABV or gender in their research. METHODS: We reviewed 240 research protocols approved by the University of Pennsylvania Investigational Review Board (IRB) consecutively submitted between January and July 2016...
2017: Biology of Sex Differences
https://www.readbyqxmd.com/read/28647933/a-new-system-of-documentation-to-improve-dietitian-physician-crosstalk
#5
Shelly Rachman-Elbaum, Aliza H Stark, Josefa Kachal, Teresa W Johnson, Bat Sheva Porat-Katz
BACKGROUND: Standardization of the dietetic care process allows for early identification of malnutrition and metabolic disorders, interdisciplinary collaboration among the medical team, and improved quality of patient care. Globally, dietitians are adopting a nutrition care model that integrates national regulations with professional scope of practice. Currently, Israel lacks a standardized dietetic care process and documentation terminology. OBJECTIVES: To assess the utilization of a novel sectoral documentation system for nutrition care in Israel...
June 2017: Israel Medical Association Journal: IMAJ
https://www.readbyqxmd.com/read/28646290/2017-in-vitro-biology-meeting-june-10-14-raleigh-north-carolina-late-submission-abstracts
#6
(no author information available yet)
No abstract text is available yet for this article.
June 23, 2017: In Vitro Cellular & Developmental Biology. Animal
https://www.readbyqxmd.com/read/28644742/new-legal-requirements-for-submission-of-product-information-to-poisons-centres-in-eu-member-states
#7
Ronald de Groot, Pieter Brekelmans, Herbert Desel, Irma de Vries
In the past eight years, the European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) has been intensively involved in a European Commission led process to develop EU legislation on the information of hazardous products that companies have to notify to EU Poisons Centres (or equivalent "appointed bodies"). As a result of this process, the Commission adopted Regulation (EU) No 2017/542, amending the CLP Regulation by adding an Annex on harmonised product submission requirements. Harmonised mixture information requirements: Detailed and consistent information on the composition of the hazardous product will become available to EU Poisons Centres (PC)...
June 23, 2017: Clinical Toxicology
https://www.readbyqxmd.com/read/28641993/peer-review-for-selection-of-oral-presentations-for-conferences-are-we-reliable
#8
Myriam Deveugele, Jonathan Silverman
INTRODUCTION: Although peer-review for journal submission, grant-applications and conference submissions has been called 'a counter- stone of science', and even 'the gold standard for evaluating scientific merit', publications on this topic remain scares. Research that has investigated peer-review reveals several issues and criticisms concerning bias, poor quality review, unreliability and inefficiency. The most important weakness of the peer review process is the inconsistency between reviewers leading to inadequate inter-rater reliability...
June 16, 2017: Patient Education and Counseling
https://www.readbyqxmd.com/read/28641506/regulatory-forum-opinion-piece-imaging-applications-in-toxicologic-pathology-recommendations-for-use-in-regulated-nonclinical-toxicity-studies
#9
Robert R Maronpot, Abraham Nyska, Sean P Troth, Kathleen Gabrielson, Polina Sysa-Shah, Vyacheslav Kalchenko, Yuri Kuznetsov, Alon Harmelin, Yael S Schiffenbauer, David Bonnel, Jonathan Stauber, Yuval Ramot
Available imaging systems for use in preclinical toxicology studies increasingly show utility as important tools in the toxicologic pathologist's armamentarium, permit longitudinal evaluation of functional and morphological changes in tissues, and provide important information such as organ and lesion volume not obtained by conventional toxicology study parameters. Representative examples of practical imaging applications in toxicology research and preclinical studies are presented for ultrasound, positron emission tomography/single-photon emission computed tomography, optical, magnetic resonance imaging, and matrix-assisted laser desorption ionization-imaging mass spectrometry imaging...
June 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28637296/omixcore-a-web-server-for-prediction-of-protein-interactions-with-large-rna
#10
Alexandros Armaos, Davide Cirillo, Gian Gaetano Tartaglia
Summary: Here we introduce omiXcore, a server for calculations of protein binding to large RNAs (> 500 nucleotides). Our webserver allows (i) use of both protein and RNA sequences without size restriction; (ii) pre-compiled library for exploration of human long intergenic RNAs (lincRNAs) interactions; (iii) prediction of binding sites. Results: omiXcore was trained and tested on enhanced UV Cross-Linking and ImmunoPrecipitation (eCLIP) data. The method discriminates interacting and non-interacting protein-RNA pairs and identifies RNA binding sites with Areas under the ROC curve > 0...
June 15, 2017: Bioinformatics
https://www.readbyqxmd.com/read/28635189/a-new-deal-for-the-monaldi-archives-for-chest-disease
#11
The Editors
The Editors: Antonio Spanevello, Bruno Balbi, Francesco Fattirolli, Furio Colivicchi.This issue marks a change in the Editorial Board of Monaldi Archives for Chest Disease. We would like to take this opportunity to impart some news on the current status of the journal. Our submissions are increasing, citations to our papers are rising, and recognition of the journal is broadening. Overall, 2016 has been a good year for the journal. Several changes are being made and several more are coming soon. Yet, focussing on the results achieved only is not our main goal, hence we now direct our efforts toward reaching an even greater impact...
May 18, 2017: Monaldi Archives for Chest Disease, Archivio Monaldi Per le Malattie del Torace
https://www.readbyqxmd.com/read/28635096/what-happens-to-your-submission-at-australasian-journal-on-ageing
#12
EDITORIAL
Lynne Parkinson, Jane Sims
No abstract text is available yet for this article.
June 2017: Australasian Journal on Ageing
https://www.readbyqxmd.com/read/28634590/the-immune-epitope-database-how-data-are-entered-and-retrieved
#13
REVIEW
Ward Fleri, Kerrie Vaughan, Nima Salimi, Randi Vita, Bjoern Peters, Alessandro Sette
Easy access to a vast collection of experimental data on immune epitopes can greatly facilitate the development of therapeutics and vaccines. The Immune Epitope Database and Analysis Resource (IEDB) was developed to provide such a resource as a free service to the biomedical research community. The IEDB contains epitope and assay information related to infectious diseases, autoimmune diseases, allergic diseases, and transplant/alloantigens for humans, nonhuman primates, mice, and any other species studied. It contains T cell, B cell, MHC binding, and MHC ligand elution experiments...
2017: Journal of Immunology Research
https://www.readbyqxmd.com/read/28633003/assessment-of-selected-overdose-poisoning-indicators-in-health-care-administrative-data-in-4-states-2012
#14
Beth Hume, Barbara Gabella, Jeanne Hathaway, Scott Proescholdbell, Cristy Sneddon, Elizabeth Brutsch, Riley Hedin, Christopher J Drucker
OBJECTIVES: In 2012, a consensus document was developed on drug overdose poisoning definitions. We took the opportunity to apply these new definitions to health care administrative data in 4 states. Our objective was to calculate and compare drug (particularly opioid) poisoning rates in these 4 states for 4 selected Injury Surveillance Workgroup 7 (ISW7) drug poisoning indicators, using 2 ISW7 surveillance definitions, Option A and Option B. We also identified factors related to the health care administrative data used by each state that might contribute to poisoning rate variations...
January 1, 2017: Public Health Reports
https://www.readbyqxmd.com/read/28631581/the-writer-s-guide-to-education-scholarship-in-emergency-medicine-education-innovations-part-3
#15
Andrew K Hall, Carly Hagel, Teresa M Chan, Brent Thoma, Aleisha Murnaghan, Farhan Bhanji
OBJECTIVE: The scholarly dissemination of innovative medical education practices helps broaden the reach of this type of work, allowing scholarship to have an impact beyond a single institution. There is little guidance in the literature for those seeking to publish program evaluation studies and innovation papers. This study aims to derive a set of evidence-based features of high-quality reports on innovations in emergency medicine (EM) education. METHODS: We conducted a scoping review and thematic analysis to determine quality markers for medical education innovation reports, with a focus on EM...
June 20, 2017: CJEM
https://www.readbyqxmd.com/read/28629816/tinospora-species-an-overview-of-their-modulating-effects-on-the-immune-system
#16
REVIEW
Md Areeful Haque, Ibrahim Jantan, Syed Nasir Abbas Bukhari
ETHNOPHARMACOLOGICAL RELEVANCE: Studies on the effects of natural immunomodulators to heal various diseases related to the immune system have been a growing interest in recent years. Amongst the medicinal plants, Tinospora species (family; Menispermaceae) have been one of the widely investigated plants for their modulating effects on the immune system due to their wide use in ethnomedicine to treat various ailments related to immune-related diseases. However, their ethnopharmacological uses are mainly with limited or without scientific basis...
June 16, 2017: Journal of Ethnopharmacology
https://www.readbyqxmd.com/read/28628225/utilization-of-the-bridging-strategy-for-the-development-of-new-drugs-in-oncology-to-avoid-drug-lag
#17
Seiji Kogure, Nobuyuki Koyama, Shinji Hidaka
Global trial (GT) strategy and bridging (BG) strategy are currently the main clinical development strategies of oncology drugs in Japan, but the relationship between development style and drug lag and how the bridging strategy has contributed to the solution of drug lag have not been clear. We investigated the potential factors that influenced submission lag (SL), and also compared the differences in SL among early-initiation BG strategy, late-initiation BG strategy, and GT strategy. A stepwise linear regression analysis identified the potential factors that shorten SL: development start lag and development style...
June 19, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28626781/both-cladribine-and-alemtuzumab-may-effect-ms-via-b-cell-depletion
#18
David Baker, Samuel S Herrod, Cesar Alvarez-Gonzalez, Lukasz Zalewski, Christo Albor, Klaus Schmierer
OBJECTIVE: To understand the efficacy of cladribine (CLAD) treatment in MS through analysis of lymphocyte subsets collected, but not reported, in the pivotal phase III trials of cladribine and alemtuzumab induction therapies. METHODS: The regulatory submissions of the CLAD Tablets Treating Multiple Sclerosis Orally (CLARITY) (NCT00213135) cladribine and Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, study one (CARE-MS I) (NCT00530348) alemtuzumab trials were obtained from the European Medicine Agency through Freedom of Information requests...
July 2017: Neurology® Neuroimmunology & Neuroinflammation
https://www.readbyqxmd.com/read/28625842/dynamics-of-scientific-publications-on-the-mers-cov-outbreaks-in-saudi-arabia
#19
REVIEW
Ali Rabaan, Shamsah H Al-Ahmed, Ali M Bazzi, Jaffar A Al-Tawfiq
Middle East Respiratory Syndrome Coronavirus (MERS-CoV) is an emerging disease with a relatively high case fatality rate. Most cases have been reported from Saudi Arabia, and the disease epidemic potential is considered to be limited. However, human-human transmission has occurred, usually in the context of healthcare facility-associated outbreaks. The scientific and medical community depends on timely publication of epidemiological information on emerging diseases during outbreaks to appropriately target public health responses...
June 15, 2017: Journal of Infection and Public Health
https://www.readbyqxmd.com/read/28621031/article-submission-is-the-true-obstacle-of-publishing
#20
EDITORIAL
P B Persson
Tempers flare as the chairman seeks rapid publication to meet grant deadlines, the assistant professor lacking tenure aims for the highest impact factor, whereas the postdoc is sick and tired of ever more rebuttals, and simply wants to end the seemingly endless rejection-resubmission-cycle. This article is protected by copyright. All rights reserved.
June 16, 2017: Acta Physiologica
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