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https://www.readbyqxmd.com/read/28088344/design-control-considerations-for-biologic-device-combination-products
#1
Dave Anderson, Roger Liu, J Anand Subramony, Jon Cammack
Combination products are therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. Historically, biologics development involved identifying efficacious doses administered to patients intravenously or perhaps by a syringe. Until fairly recently, there has been limited focus on developing an accompanying medical device, such as a prefilled syringe or auto-injector, to enable easy and more efficient delivery. For the last several years, and looking forward, where there may be little to distinguish biologics medicines with relatively similar efficacy profiles, the biotechnology market is beginning to differentiate products by patient-focused, biologic-device based combination products...
January 11, 2017: Advanced Drug Delivery Reviews
https://www.readbyqxmd.com/read/28087889/national-audit-of-the-quality-of-pain-relief-provided-in-emergency-departments-in-aotearoa-new-zealand-the-prized-1-study
#2
(no author information available yet)
OBJECTIVE: Pain is a common feature of ED presentations and the timely provision of adequate analgesia is important for patient care. However, there is currently no New Zealand data with respect to this indicator of care quality. The present study aimed to provide a baseline for the quality of care with respect to the provision of timely and adequate analgesia in New Zealand EDs. METHODS: The present study is a secondary analysis of data initially collected for the Shorter Stays in Emergency Department Study, using a retrospective chart review of 1685 randomly selected ED presentations (2006-2012) from 26 New Zealand public hospital EDs...
January 13, 2017: Emergency Medicine Australasia: EMA
https://www.readbyqxmd.com/read/28087422/nano-qsar-in-cell-biology-model-of-cell-viability-as-a-mathematical-function-of-available-eclectic-data
#3
Alla P Toropova, Andrey A Toropov
The prediction of biochemical endpoints is an important task of the modern medicinal chemistry, cell biology, and nanotechnology. Simplified molecular input-line entry system (SMILES) is a tool for representation of the molecular structure. In particular, SMILES can be used to build up the quantitative structure - property / activity relationships (QSPRs/QSARs). The QSPR/QSAR is a tool to predict an endpoint for a new substance, which has not been examined in experiment. Quasi-SMILES are representation of eclectic data related to an endpoint...
January 10, 2017: Journal of Theoretical Biology
https://www.readbyqxmd.com/read/28087312/immunisation-choice-of-host-adjuvants-and-boosting-schedules-with-emphasis-on-polyclonal-antibody-production
#4
REVIEW
Philippe Delahaut
Polyclonal antibodies are frequently used as immunodiagnostic tools in fundamental research. They are also used for routine diagnostic purposes in human and veterinary medicine and for quality control procedures in the food-processing industry. The antibody is a major component of the detection system. It binds with the molecule to be identified. This conjugate is subsequently revealed by means of binding the antibody with a radio-isotope, a fluorescent substance, an enzyme inducing a color change, or a biosensor based analytical system...
January 10, 2017: Methods: a Companion to Methods in Enzymology
https://www.readbyqxmd.com/read/28087196/improving-hospital-care-of-patients-with-intellectual-and-developmental-disabilities
#5
Sarah H Ailey, Paula J Brown, Caitlin M Ridge
People with intellectual disabilities and developmental disabilities (IDD) face poorer care and outcomes when hospitalized than patients without IDD. A panel discussion Hospital care for individuals with IDD: The Issues and Challenges was held at the Annual Conference of the American Academy of Developmental Medicine and Dentistry, held in Chicago July 8-10, 2016. Among the panelists were representatives from Rush University Medical Center in Chicago, IL and Saint Barnabas Medical Center in Livingston, NJ who discussed efforts to improve hospital care of patients with IDD at their institutions...
January 4, 2017: Disability and Health Journal
https://www.readbyqxmd.com/read/28086953/student-and-faculty-perceptions-on-the-rapid-scale-up-of-medical-students-in-ethiopia
#6
Brittney S Mengistu, Holly Vins, Caitrin M Kelly, Daphne R McGee, Jennifer O Spicer, Miliard Derbew, Abebe Bekele, Damen Haile Mariam, Carlos Del Rio, Henry M Blumberg, Dawn L Comeau
BACKGROUND: Ethiopia is a country of over 94 million people that has a severe physician shortage with approximately only 2.5 physicians per 100,000 persons. Recently, the Ethiopian government implemented a "flood and retain" initiative to rapidly increase the quantity of physicians in Ethiopia. Consequently, medical student enrollment at Addis Ababa University (AAU) School of Medicine increased from 100 to approximately 300-400 students per class. This study evaluated the impact of the rapid scale-up in the number of medical students on the quality of medical education at AAU and the impact of the U...
January 13, 2017: BMC Medical Education
https://www.readbyqxmd.com/read/28086866/perceptions-and-utilization-of-generic-medicines-in-guatemala-a-mixed-methods-study-with-physicians-and-pharmacy-staff
#7
David Flood, Irène Mathieu, Anita Chary, Pablo García, Peter Rohloff
BACKGROUND: Access to low-cost essential generic medicines is a critical health policy goal in low-and-middle income countries (LMICs). Guatemala is an LMIC where there is both limited availability and affordability of these medications. However, attitudes of physicians and pharmacy staff regarding low-cost generics, especially generics for non-communicable diseases (NCDs), have not been fully explored in Guatemala. METHODS: Semi-structured interviews with 30 pharmacy staff and 12 physicians in several highland towns in Guatemala were conducted...
January 13, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28086761/is-treatment-resistant-schizophrenia-categorically-distinct-from-treatment-responsive-schizophrenia-a-systematic-review
#8
Amy L Gillespie, Ruta Samanaite, Jonathan Mill, Alice Egerton, James H MacCabe
BACKGROUND: Schizophrenia is a highly heterogeneous disorder, and around a third of patients are treatment-resistant. The only evidence-based treatment for these patients is clozapine, an atypical antipsychotic with relatively weak dopamine antagonism. It is plausible that varying degrees of response to antipsychotics reflect categorically distinct illness subtypes, which would have significant implications for research and clinical practice. If these subtypes could be distinguished at illness onset, this could represent a first step towards personalised medicine in psychiatry...
January 13, 2017: BMC Psychiatry
https://www.readbyqxmd.com/read/28081562/male-facial-appearance-and-offspring-mortality-in-two-traditional-societies
#9
Lynda G Boothroyd, Alan W Gray, Thomas N Headland, Ray T Uehara, David Waynforth, D Michael Burt, Nicholas Pound
It has been hypothesised that facial traits such as masculinity and a healthy appearance may indicate heritable qualities in males (e.g. immunocompetence) and that, consequently, female preferences for such traits may function to increase offspring viability and health. However, the putative link between paternal facial features and offspring health has not previously been tested empirically in humans. Here we present data from two traditional societies with little or no access to modern medicine and family planning technologies...
2017: PloS One
https://www.readbyqxmd.com/read/28080206/probiotics-d-lactic-acidosis-oxidative-stress-and-strain-specificity
#10
Luis Vitetta, Samantha Coulson, Michael Thomsen, Tony Nguyen, Sean Hall
1. The existence of an implicit living microscopic world, composed primarily of bacteria, has been known for centuries. The exact mechanisms that govern the contribution of bacteria to human health and disease have only recently become the subject of intense research efforts. Within this very evident shift in paradigms, the rational design of probiotic formulations has led to the creation of an industry that seeks to progress the engineering of probiotic bacteria that produce metabolites that may enhance human host health and prevent disease...
January 12, 2017: Gut Microbes
https://www.readbyqxmd.com/read/28079780/subspecialty-influence-on-scientific-peer-review-for-an-obstetrics-and-gynecology-journal-with-a-high-impact-factor
#11
Laura I Parikh, Rebecca S Benner, Thomas W Riggs, Nicholas Hazen, Nancy C Chescheir
OBJECTIVE: To evaluate whether quality of peer review and reviewer recommendation differ based on reviewer subspecialty in obstetrics and gynecology and to determine the role of experience on reviewer recommendation. METHODS: We performed a retrospective cohort study of reviews submitted to Obstetrics & Gynecology between January 2010 and December 2014. Subspecialties were determined based on classification terms selected by each reviewer and included all major obstetrics and gynecology subspecialties, general obstetrics and gynecology, and nonobstetrics and gynecology categories...
January 9, 2017: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/28078848/clinical-effects-of-thermotherapy-in-combination-with-intracavitary-infusion-of-traditional-chinese-medicine-in-the-treatment-of-malignant-pleural-effusion
#12
Y Gu, L Jiang, J H Miao, T S Liang, Q C Kan, D K Yang
Malignant fluid, a commonly seen tumor associated complication, mainly includes peritoneal effusion, malignant pleural effusion and pericardial effusion. It can produce huge negative influence on the quality of life of patients and even lead to death. Treatment of malignant effusion is one of the effective measures for improving life expectancy of patients. To evaluate the effect of thermotherapy in combination with intracavitary infusion of Kangai injection in treating malignant pleural effusion, 195 patients who received treatment from April 2010 to October 2014 in the First Affiliated Hospital of Zhengzhou University were selected and divided into an observation group and two control groups (group A and B)...
October 2016: Journal of Biological Regulators and Homeostatic Agents
https://www.readbyqxmd.com/read/28078812/gentiana-scabra-bunge-formula-for-herpes-zoster-biological-actions-of-key-herbs-and-systematic-review-of-efficacy-and-safety
#13
REVIEW
Kaiyi Wang, Meaghan E Coyle, Suzi Mansu, Anthony Lin Zhang, Charlie Changli Xue
This study reviewed the biological action of key herbs and evaluated systematically the efficacy and safety of oral Gentiana formula for herpes zoster (HZ). Experimental studies relevant to HZ were identified in PubMed. Randomized controlled trials using Gentiana formula for HZ were identified from nine English and Chinese databases. The primary outcome was evaluation of pain. Potential risk of bias was assessed. Meta-analysis was conducted using mean difference or risk ratio with 95% confidence intervals. Key herbs Gentiana scabra Bunge, Gentiana triflora Pall, Scutellaria baicalensis Georgi, and Gardenia jasminoides Ellis have shown antiinflammatory actions through inhibition of inflammatory cytokines and pro-inflammatory enzymes...
January 12, 2017: Phytotherapy Research: PTR
https://www.readbyqxmd.com/read/28078656/biosimilars-for-the-treatment-of-cancer-a-systematic-review-of-published-evidence
#14
REVIEW
Ira Jacobs, Reginald Ewesuedo, Sadiq Lula, Charles Zacharchuk
BACKGROUND: Biologic treatments for cancer continue to place a significant economic burden on healthcare stakeholders. Biosimilar therapies may help reduce this burden through cost savings, thereby increasing patient access. OBJECTIVES: The purpose of this study was to collate all published data to assess the weight of available evidence (quantity and quality) for proposed monoclonal antibody biosimilars and intended copies, for the treatment of cancer. METHODS: MEDLINE(®), Embase(®), and ISI Web of Science(®) databases were searched to September 2015...
January 11, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28078640/development-of-the-pediatric-quality-of-life-inventory-neurofibromatosis-type-1-module-items-for-children-adolescents-and-young-adults-qualitative-methods
#15
Kavitha Nutakki, James W Varni, Sheila Steinbrenner, Claire B Draucker, Nancy L Swigonski
Health-related quality of life (HRQOL) is arguably one of the most important measures in evaluating effectiveness of clinical treatments. At present, there is no disease-specific outcome measure to assess the HRQOL of children, adolescents and young adults with Neurofibromatosis Type 1 (NF1). This study aimed to develop the items and support the content validity for the Pediatric Quality of Life Inventory™ (PedsQL™) NF1 Module for children, adolescents and young adults. The iterative process included multiphase qualitative methods including a literature review, survey of expert opinions, semi-structured interviews, cognitive interviews and pilot testing...
January 11, 2017: Journal of Neuro-oncology
https://www.readbyqxmd.com/read/28077162/a-fixed-inhaled-nitrous-oxide-oxygen-mixture-as-an-analgesic-for-adult-cancer-patients-with-breakthrough-pain-study-protocol-for-a-randomized-controlled-trial
#16
Qiang Liu, Yu Wang, Xiang-Jiang Luo, Ning-Ju Wang, Ping Chen, Xin Jin, Guo-Xia Mu, Xiao-Min Chai, Yue-Juan Zhang, Yu-Xiang Li, Jian-Qiang Yu
BACKGROUND: The management of breakthrough pain in cancer patients is always a challenge for medical professions. Occurring in 80% of cancer patients with advanced disease, breakthrough pain significantly decreases both patient's and caregiver's quality of life. The aim of this study is to assess the analgesic efficacy of a fixed inhaled nitrous oxide/oxygen mixture for adult cancer patients with breakthrough pain. METHODS/DESIGN: This is a randomized, placebo-controlled, double-blind study; it will be conducted in the General Hospital of Ningxia Medical University...
January 11, 2017: Trials
https://www.readbyqxmd.com/read/28076656/combined-inhaled-beta-agonist-and-anticholinergic-agents-for-emergency-management-in-adults-with-asthma
#17
REVIEW
Scott W Kirkland, Christine Vandenberghe, Britt Voaklander, Taylor Nikel, Sandra Campbell, Brian H Rowe
BACKGROUND: Inhaled short-acting anticholinergics (SAAC) and short-acting beta₂-agonists (SABA) are effective therapies for adult patients with acute asthma who present to the emergency department (ED). It is unclear, however, whether the combination of SAAC and SABA treatment is more effective in reducing hospitalisations compared to treatment with SABA alone. OBJECTIVES: To conduct an up-to-date systematic search and meta-analysis on the effectiveness of combined inhaled therapy (SAAC + SABA agents) vs...
January 11, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28076546/pharmacist-s-contribution-to-the-promotion-of-access-and-rational-use-of-essential-medicines-in-sus
#18
Daniela Oliveira de Melo, Lia Lusitana Cardozo de Castro
Objective: to describe the pharmaceutical inclusion process in a Basic Health Unit multidisciplinary team and evaluate results related to rational use and promotion of access to essential medicines. Methods: This is a descriptive, cross-sectional study conducted in a primary care health unit in the city of São Paulo. Pharmacist's activities were evaluated regarding the service structure and organization and prescribing quality improvement, guidance method creation, and implementation of clinical pharmacy service...
January 2017: Ciência & Saúde Coletiva
https://www.readbyqxmd.com/read/28076545/economic-evaluation-of-the-programs-rede-farm%C3%A3-cia-de-minas-do-sus-versus-farm%C3%A3-cia-popular-do-brasil
#19
Marina Morgado Garcia, Augusto Afonso Guerra, Francisco de Assis Acúrcio
We conducted an economic assessment of the Pharmaceutical Assistance - Rede Farmácia de Minas Gerais-RFMG and Farmácia Popular do Brasil-FPB to ascertain which of the two models stands out as the most efficient. To do this, a model, which consisted of a study of incurred costs in both programs, up to the dispensing of medicine to citizens, was developed. The uncertainties of the proposed model were tested using the Monte Carlo method. If the entire population initially estimated in the RFMG were attended in the FPB, there would be an additional cost of R$ 139,324,050...
January 2017: Ciência & Saúde Coletiva
https://www.readbyqxmd.com/read/28076536/-quality-of-life-of-family-caregivers-of-adults-with-spinal-cord-injury-a-systematic-review
#20
Cejane Oliveira Martins Prudente, Maysa Ferreira Martins Ribeiro, Celmo Celeno Porto
The scope of this study was to analyze the quality of life of family caregivers of adults with spinal cord injury. Two researchers conducted a systematic review independently, based on articles published between 2000 to 2014, using the key words quality of life and caregivers or family and spinal cord, in Portuguese, English and Spanish. The search was conducted in the Virtual Health Library (BVS) and the United States National Library of Medicine (PubMED) databases. Caregivers of tetraplegics have a worse quality of life than caregivers of paraplegics...
January 2017: Ciência & Saúde Coletiva
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