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https://www.readbyqxmd.com/read/28344480/changing-paradigms-in-bioequivalence-trials-submitted-to-the-ema-for-evaluation-a-clinical-and-regulatory-perspective
#1
Nathaniel Refalo, Daniel Chetcuti, Amy Tanti, Anthony Serracino-Inglott, John Joseph Borg
BACKGROUND: The selection of a robust bioequivalence (BE) study designs for registering a generic product remains still a hard task. This task is still challenging despite the fact that generic products are much needed by health care providers in economical terms. Thus, BE study designs could be a means to allow companies to reduce costs and reach the market earlier. We therefore investigated whether different approaches in various products assessed by the European Medicines Agency during the approval phase resulted in a reduction in resources required to show bioequivalence for different medicinal products...
February 2017: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
https://www.readbyqxmd.com/read/28341083/scientific-publications-in-gastroenterology-and-hepatology-in-taiwan-an-analysis-of-web-of-science-from-1993-to-2013
#2
Hsiao-Ting Chang, Ming-Hwai Lin, I-Hsuan Hwang, Tzeng-Ji Chen, Han-Chieh Lin, Ming-Chih Hou, Shinn-Jang Hwang
BACKGROUND: Scientific publications are important for evaluating the achievements of a medical specialty or discipline. Gastroenterology and Hepatology is a medical specialty in great demand in Taiwan, therefore, this study aimed to analyze the Gastroenterology and Hepatology publications from 1993 to 2013 in Taiwan, using the Web of Science (WoS) database. METHODS: Scientific publications from departments/institutes of gastroenterology and hepatology were retrieved and analyzed from the WoS database, which included articles published in the Science Citation Index Expanded and Social Science Citation Index journals from 1993 to 2013...
February 2017: Journal of the Chinese Medical Association: JCMA
https://www.readbyqxmd.com/read/28340933/financial-compensation-of-oocyte-donors-an-ethics-committee-opinion
#3
(no author information available yet)
Financial compensation of women donating oocytes for infertility therapy or for research is justified on ethical grounds and should acknowledge the time, inconvenience, and discomfort associated with screening, ovarian stimulation, and oocyte retrieval, and not vary according to the planned use of the oocytes, the number or quality of oocytes retrieved, the number or outcome of prior donation cycles, or the donor's ethnic or other personal characteristics. This document replaces the document of the same name, last published in 2007 (Fertil Steril 2007;88:305-9)...
December 2016: Fertility and Sterility
https://www.readbyqxmd.com/read/28339912/pharmacogenomics-and-patient-treatment-parameters-to-opioid-treatment-in-chronic-pain-a-focus-on-morphine-oxycodone-tramadol-and-fentanyl
#4
Renae A Lloyd, Elizabeth Hotham, Catherine Hall, Marie Williams, Vijayaprakash Suppiah
Objective. : Opioids are one of the most commonly prescribed medicines for chronic pain. However, their use for chronic pain has been controversial. The objective of this literature review was to identify the role of genetic polymorphisms on patient treatment parameters (opioid dose requirements, response, and adverse effects) for opioids used in malignant and nonmalignant chronic pain. The opioids that this review focuses on are codeine, morphine, oxycodone, tramadol, and fentanyl...
February 24, 2017: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/28338242/what-can-community-pharmacy-learn-from-the-experiences-of-transition-to-practice-for-novice-doctors-and-nurses-a-narrative-review
#5
REVIEW
Esnath Magola, Sarah C Willis, Ellen I Schafheutle
OBJECTIVES: In the absence of literature reporting the transition experiences of novice community pharmacists, peer-reviewed evidence on the transition experiences of novice doctors and nurses was identified and reviewed. Specific objectives included identifying the challenges to transition and their perceived impact, before considering the implications for novice community pharmacists. METHODS: The electronic databases MEDLINE, EMBASE, CINAHL, PsycINFO and ScienceDirect were searched for full peer-reviewed original research papers published 1990-March 2015, reporting the transition experiences of novice doctors and nurses...
March 24, 2017: International Journal of Pharmacy Practice
https://www.readbyqxmd.com/read/28337782/three-dimensional-oxygen-enhanced-mri-of-the-human-lung-at-1-5t-with-ultra-fast-balanced-steady-state-free-precession
#6
Orso Pusterla, Grzegorz Bauman, Oliver Bieri
PURPOSE: To assess the feasibility of 3D oxygen-enhanced (OE) MRI of the lung at 1.5T using multi-volumetric ultra-fast balanced steady-state free precession (ufSSFP) acquisitions. METHODS: Isotropic imaging of the lung for OE-MRI was performed with an adapted 3D ufSSFP sequence using five breath-hold acquisitions ranging from functional residual capacity to tidal inspiration under both normoxic (room air) and hyperoxic (100% O2 ) gas conditions. For each O2 concentration, a sponge model (which captures the parenchymal signal intensity variation as a function of the lung volume) was fitted to the acquired multi-volumetric datasets after semiautomatic lung segmentation and deformable image registration...
March 24, 2017: Magnetic Resonance in Medicine: Official Journal of the Society of Magnetic Resonance in Medicine
https://www.readbyqxmd.com/read/28335766/barriers-to-the-conduct-and-application-of-research-in-complementary-and-alternative-medicine-a-systematic-review
#7
Yasamin Veziari, Matthew J Leach, Saravana Kumar
BACKGROUND: The popularity of Complementary and alternative medicine (CAM) has grown considerably over the past few decades. This has been accompanied by increasing public pressure for CAM to be evidence-based. Notwithstanding, the conduct and application of research in CAM faces a number of obstacles. No systematic review has mapped these barriers to date. Therefore, this systematic literature review aimed to explore, identify and map the barriers to the conduct and application of research in CAM...
March 23, 2017: BMC Complementary and Alternative Medicine
https://www.readbyqxmd.com/read/28333661/does-your-drug-expertise-include-clinical-pharmaceutics
#8
David W Newton
Whose job is it to protect patients from harm from drug instabilities and incompatibilities and other aspects of clinical pharmaceutics? Pharmacists are better educated via multiple required general and organic chemistry prerequisite and professional curricula medicinal chemistry and pharmaceutics courses. Therefore, no healthcare professional other than pharmacists are nicknamed drug experts or are better formally educated to master drug chemistry in the bottle (i.e., injection stability and compatibility/incompatibility clinical pharmaceutics) as a prerequisite for drug administration to cause safe and effective drug chemistry in the body (i...
May 2016: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28326520/transdermal-hormone-replacement-therapy-with-nanostructured-medicines
#9
Fatemeh Abdi, Tayebeh Darooneh, Maryam Ghorbani, Farzaneh Banihashemi, Nasibeh Roozbeh
OBJECTIVES: Due to hormonal changes during the menopause, women experience a variety of perimenopause and postmenopause symptoms. This review examines the various aspects of nanostructured hormone therapy and its application in the treatments of menopausal symptoms. MATERIAL AND METHODS: Excerpta Medica DataBase, Medical Literature Analysis and Retrieval System Online, Web of Science, and Google Scholar were searched basing on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines...
2017: Ginekologia Polska
https://www.readbyqxmd.com/read/28325132/physical-symptoms-and-working-performance-in-female-breast-cancer-survivors-a-systematic-review
#10
Kamilla Zomkowski, Bruna Cruz de Souza, Fabiana Pinheiro da Silva, Géssica Maria Moreira, Natália de Souza Cunha, Fabiana Flores Sperandio
PURPOSE: The aim of this systematic review was to summarize and systematize the information about physical symptoms and its relation with work activity on female Breast Cancer Survivors (BCS). METHODS: A systematic search was performed on the databases MEDLINE/PubMed (via National Library of Medicine), SCOPUS (Elsevier), Web of Science (Thomson Reuters Scientific) and CINAHL with full text (EBSCO), including papers about physical impairments experienced by female workers who have had breast cancer...
March 21, 2017: Disability and Rehabilitation
https://www.readbyqxmd.com/read/28320410/bibliometric-analysis-of-medicine-related-publications-on-refugees-asylum-seekers-and-internally-displaced-people-2000-2015
#11
Waleed M Sweileh
BACKGROUND: Wars and violent domestic conflicts have forced millions of people to move outside their homes. Meeting the basic health needs of those people requires an understanding of research activity and research output on this topic. The objective of this study was to shed light on the quantity and impact of medicine - related publications on refugees, asylum seekers and internally displaced people (IDP). METHOD: Scopus database was used to retrieve required data...
March 20, 2017: BMC International Health and Human Rights
https://www.readbyqxmd.com/read/28318936/vector-model-supported-approach-in-prostate-plan-optimization
#12
Eva Sau Fan Liu, Vincent Wing Cheung Wu, Benjamin Harris, Margot Lehman, David Pryor, Lawrence Wing Chi Chan
Lengthy time consumed in traditional manual plan optimization can limit the use of step-and-shoot intensity-modulated radiotherapy/volumetric-modulated radiotherapy (S&S IMRT/VMAT). A vector model base, retrieving similar radiotherapy cases, was developed with respect to the structural and physiologic features extracted from the Digital Imaging and Communications in Medicine (DICOM) files. Planning parameters were retrieved from the selected similar reference case and applied to the test case to bypass the gradual adjustment of planning parameters...
March 17, 2017: Medical Dosimetry: Official Journal of the American Association of Medical Dosimetrists
https://www.readbyqxmd.com/read/28317886/systems-pharmacology-based-strategy-to-screen-new-adjuvant-for-hepatitis-b-vaccine-from-traditional-chinese-medicine-ophiocordyceps-sinensis
#13
Jingbo Wang, Rui Liu, Baoxiu Liu, Yan Yang, Jun Xie, Naishuo Zhu
Adjuvants are common component for many vaccines but there are still few licensed for human use due to low efficiency or side effects. The present work adopted Systems Pharmacology analysis as a new strategy to screen adjuvants from traditional Chinese medicine. Ophiocordyceps sinensis has been used for many years in China and other Asian countries with many biological properties, but the pharmacological mechanism has not been fully elucidated. First in this study, 190 putative targets for 17 active compounds in Ophiocordyceps sinensis were retrieved and a systems pharmacology-based approach was applied to provide new insights into the pharmacological actions of the drug...
March 20, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28295159/first-and-second-trimester-serum-tests-with-and-without-first-trimester-ultrasound-tests-for-down-s-syndrome-screening
#14
REVIEW
S Kate Alldred, Yemisi Takwoingi, Boliang Guo, Mary Pennant, Jonathan J Deeks, James P Neilson, Zarko Alfirevic
BACKGROUND: Down's syndrome occurs when a person has three copies of chromosome 21 (or the specific area of chromosome 21 implicated in causing Down's syndrome) rather than two. It is the commonest congenital cause of mental disability. Non-invasive screening based on biochemical analysis of maternal serum or urine, or fetal ultrasound measurements, allows estimates of the risk of a pregnancy being affected and provides information to guide decisions about definitive testing.  Before agreeing to screening tests, parents need to be fully informed about the risks, benefits and possible consequences of such a test...
March 15, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28294074/probiotics-as-a-tool-to-biosynthesize-metallic-nanoparticles-research-reports-and-patents-survey
#15
Nida Ahktar, Kamla Pathak
BACKGROUND: Probiotics are the live microbes that exert beneficial effects on the health of the host cell and thus creating novel nanoformulations via probiotic bacteria have gained tremendous momentum recently. The probiotic bacteria are being employed in synthesizing or more specifically biosynthesizing several nanoparticles like metallic as well as non-metallic nanoparticles. Biosynthesis of metallic nanoparticles is currently focused of research nowadays due to several applications thereof...
March 13, 2017: Recent Patents on Drug Delivery & Formulation
https://www.readbyqxmd.com/read/28293674/monitoring-and-analysis-of-the-change-process-in-curriculum-mapping-compared-to-the-national-competency-based-learning-objective-catalogue-for-undergraduate-medical-education-nklm-at-four-medical-faculties-part-i-conducive-resources-and-structures
#16
Maria Lammerding-Koeppel, Marianne Giesler, Maryna Gornostayeva, Elisabeth Narciss, Annette Wosnik, Stephan Zipfel, Jan Griewatz, Olaf Fritze
Objective: After passing of the National Competency-based Learning Objectives Catalogue in Medicine (Nationaler Kompetenzbasierter Lernzielkatalog Medizin, [NKLM, retrieved on 22.03.2016]), the German medical faculties must take inventory and develop their curricula. NKLM contents are expected to be present, but not linked well or sensibly enough in locally grown curricula. Learning and examination formats must be reviewed for appropriateness and coverage of the competences. The necessary curricular transparency is best achieved by systematic curriculum mapping, combined with effective change management...
2017: GMS Journal for Medical Education
https://www.readbyqxmd.com/read/28285614/effectiveness-of-co-treatment-with-traditional-chinese-medicine-and-letrozole-for-polycystic-ovary-syndrome-a-meta-analysis
#17
Qian-Wen Ma, Yong Tan
BACKGROUND: Polycystic ovary syndrome (PCOS) is an endocrine disease that affects gynecological health. Treatment of PCOS remains a big challenge for clinicians. OBJECTIVE: This meta-analysis was developed to compare the efficacy of co-treatment with traditional Chinese medicine (TCM) and letrozole against letrozole monotherapy in the treatment of PCOS. SEARCH STRATEGY: Randomized controlled trials (RCTs) were electronically retrieved from PubMed, Cochrane Library, China Biomedical Literature Database, China National Knowledge Infrastructure and Wanfang Data; related papers that were not available electronically were manually checked...
March 2017: Journal of Integrative Medicine
https://www.readbyqxmd.com/read/28280978/spanish-society-of-vascular-and-interventional-radiology-servei-bibliometric-study-2010-2015-what-how-and-where-do-spanish-interventional-radiologists-publish
#18
Celia Lahuerta, José A Guirola, Enrique Esteban, José Urbano, Alicia Laborda, Miguel Ángel De Gregorio
PURPOSE: We analyzed the scientific production of members of the Spanish Society of Vascular and Interventional Radiology (SERVEI) from 2010 to 2015. MATERIALS AND METHODS: We retrospectively analyzed the indexed scientific productivity of all SERVEI members for the last 6 years as measured by bibliometric indexes. Different databases were used (e.g., PubMed, Scopus, Web of Knowledge) to retrieve the total number of publications, number of citations, and h-index...
March 9, 2017: Cardiovascular and Interventional Radiology
https://www.readbyqxmd.com/read/28280359/application-of-carbon-nanoparticles-in-lymph-node-dissection-and-parathyroid-protection-during-thyroid-cancer-surgeries-a-systematic-review-and-meta-analysis
#19
Lun Wang, Dong Yang, Jun-Yuan Lv, Dan Yu, Shi-Jie Xin
PURPOSE: To investigate whether carbon nanoparticles (CNs) are helpful in identifying lymph nodes and metastatic lymph nodes and in parathyroid protection during thyroid cancer surgery. METHODS: English and Chinese literature in PubMed, Cochrane Database of Systematic Reviews, EMBASE, ClinicalTrials.gov, China Biology Medicine Database, China National Knowledge Infrastructure, China Master's and Doctoral Theses Full-Text Database, Wanfang database, and Cqvip database were searched (till March 22, 2016)...
2017: OncoTargets and Therapy
https://www.readbyqxmd.com/read/28279997/association-between-highly-active-antiretroviral-therapy-and-selected-cardiovascular-disease-risk-factors-in-sub-saharan-africa-a-systematic-review-and-meta-analysis-protocol
#20
Christian Akem Dimala, Hannah Blencowe
INTRODUCTION: The increasing highly active antiretroviral therapy (HAART) coverage in sub-Saharan Africa (SSA) has been associated with increasing cardiovascular disease (CVD) incidence. However, the epidemiology of the association between HAART and CVD risk factors in SSA is sparse. We aim to assess the extent to which HAART is associated with selected cardiovascular risk factors (hypertension, diabetes, dyslipidaemia and metabolic syndrome) in SSA. METHODS AND ANALYSIS: This will be a systematic review and meta-analysis of published studies on the association between HAART and CVD risk factors retrieved from Medline, Embase, Popline, Africa-Wide Information, African Index Medicus and the Cochrane library databases...
March 9, 2017: BMJ Open
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