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https://www.readbyqxmd.com/read/27915208/maximizing-the-impact-of-physiologically-based-oral-absorption-modeling-and-simulation
#1
John I Chung, Ron C Kelly, Jan Wahlstrom, Benjamin Wu, Tian Wu, Fernando Alvarez-Nunez
The challenge of bringing innovative medicines to patients in combination with intense competition within the pharmaceutical industry have induced companies to develop quality medicines more efficiently and cost-effectively. State-of-the art approaches to advance drug development have never been so urgent. One such approach that has been gaining traction within the industry is the application of modeling and simulation. In this commentary, the benefits of physiologically-based oral absorption (PBOA) modeling and simulation in drug development are highlighted and suggestions for maximizing its impact are provided...
November 30, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27914981/complement-a-primer-for-the-coming-therapeutic-revolution
#2
REVIEW
Scott R Barnum
The complement system is an important part of the innate and adaptive immune systems. Originally characterized as a single serum component contributing to the killing of bacteria, we now know that there are close to sixty complement proteins, multiple activation pathways and a wide range of effector functions mediated by complement. The system plays a critical role in host defense against bacteria, viruses, fungi and other pathogens. However, inappropriate complement activation contributes to the pathophysiology of autoimmune diseases and many inflammatory syndromes...
November 30, 2016: Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/27914632/the-us-food-and-drug-administration-s-risk-evaluation-and-mitigation-strategy-rems-program-current-status-and-future-direction
#3
Jasmanda Wu, Juhaeri Juhaeri
The US Food and Drug Administration (FDA) Amendments Act of 2007 granted the FDA new authorities to enhance drug safety by requiring application holders to submit a proposed Risk Evaluation and Mitigation Strategy (REMS). A REMS is a required risk management plan that uses tools beyond the package insert. REMS elements may include a medication guide and patient package insert for patients and a communication plan focused on health care professionals. Elements to assure safe use (ETASUs) are put in place to mitigate a specific known serious risk when other less restrictive elements of a REMS are not sufficient to mitigate such risk...
November 30, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27914554/comparative-performance-of-ampflstr%C3%A2-identifiler%C3%A2-plus-pcr-amplification-kit-and-qiagen%C3%A2-investigator%C3%A2-idplex-plus-kit
#4
Dalad Mattayat, Thitika Kitpipit, Sukanya Phetpeng, Watee Asawutmangkul, Phuvadol Thanakiatkrai
Many forensic STR kits are currently available in the market. The AmpFLSTR® Identifiler® Plus kit, which targets 15 STRs, is commonly used worldwide. The Thai forensic DNA community is built around it in terms of instrument, databases, and interpretation. QIAGEN's IDplex Plus kit targets the same loci, but the PCR cycling time is shorter by about 90min. A direct comparison that assesses forensic parameters and applicability to casework between the two kits has never been carried out. In this study, we performed a direct comparison between the two kits using serial dilutions of two control DNA samples and 60 randomly selected casework samples, including samples taken from improvised explosive devices and terrorist raids...
December 2016: Science & Justice: Journal of the Forensic Science Society
https://www.readbyqxmd.com/read/27914272/innovation-evaluation-model-for-macro-construction-sector-companies-a-study-in-spain
#5
Mikel Zubizarreta, Jesús Cuadrado, Jon Iradi, Harkaitz García, Aimar Orbe
The innovativeness of the traditional construction sector, composed of construction companies or contractors, is not one of its strong points. Likewise, its poor productivity in comparison with other sectors, such as manufacturing, has historically been criticized. Similar features are found in the Spanish traditional construction sector, which it has been described as not very innovative. However, certain characteristics of the sector may explain this behavior; the companies invest in R+D less than in other sectors and release fewer patents, so traditional innovation evaluation indicators do not reflect the true extent of its innovative activity...
November 24, 2016: Evaluation and Program Planning
https://www.readbyqxmd.com/read/27914099/discrepancies-between-multicriteria-decision-analysis-based-ranking-and-intuitive-ranking-for-pharmaceutical-benefit-risk-profiles-in-a-hypothetical-setting
#6
K Hoshikawa, S Ono
WHAT IS KNOWN AND OBJECTIVE: Multicriteria decision analysis (MCDA) has been generally considered a promising decision-making methodology for the assessment of drug benefit-risk profiles. There have been many discussions in both public and private sectors on its feasibility and applicability, but it has not been employed in official decision-makings. For the purpose of examining to what extent MCDA would reflect the first-hand, intuitive preference of evaluators in practical pharmaceutical assessments, we conducted a questionnaire survey involving the participation of employees of pharmaceutical companies...
December 2, 2016: Journal of Clinical Pharmacy and Therapeutics
https://www.readbyqxmd.com/read/27913984/basal-insulin-persistence-associated-factors-and-outcomes-after-treatment-initiation-a-retrospective-database-study-among-people-with-type-2-diabetes-mellitus-in-japan
#7
Irene Hadjiyianni, Urvi Desai, Shuichi Suzuki, Jasmina I Ivanova, Dachuang Cao, Noam Y Kirson, Dai Chida, Caroline Enloe, Howard G Birnbaum, Magaly Perez-Nieves
INTRODUCTION: The objective of this study was to assess basal insulin persistence, associated factors, and economic outcomes for insulin-naïve people with type 2 diabetes mellitus (T2DM) in Japan. METHODS: People aged at least 18 years with T2DM with first claim for basal insulin between May 2006 and April 2013 (index date), no insulin use before index date, and continuous insurance coverage for 6 months before (baseline) and 12 months after index date were selected from the Japan Medical Center Database...
December 2, 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/27913776/necitumumab-for-the-treatment-of-squamous-cell-non-small-cell-lung-cancer
#8
Jessica K Brinkmeyer, Donald C Moore
Non-small cell lung cancer is the most common form of lung cancer, accounting for about 85% of all cases and is further subdivided into adenocarcinoma, squamous cell, and large cell carcinoma. Necitumumab (Portrazza™, Eli Lilly and Company) is an anti-epidermal growth factor receptor monoclonal antibody approved for the first-line treatment of squamous cell non-small cell lung cancer in combination with cisplatin and gemcitabine. The safety and efficacy of necitumumab has been evaluated in two-phase III clinical trials, one demonstrating a lack of efficacy in non-squamous non-small cell lung cancer and another demonstrating improvement in overall survival and progression-free survival in squamous cell non-small cell lung cancer...
December 2, 2016: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/27912895/risk-management-abilities-in-multimodal-maritime-supply-chains-visibility-and-control-perspectives
#9
Jyri Vilko, Paavo Ritala, Jukka Hallikas
Supply chain complexity and disintegration lead to increased uncertainty from a stakeholders' perspective, which is emerging as one of the major challenges of risk management. The ability to identify risks has weakened, as the responsibility of supply chain risk management is handed over to outside service providers. Regardless, the risks, their visibility and their impact depend on the position of the companies in the supply chain. The actors in the chain must therefore collaborate to create effective risk management conditions...
November 29, 2016: Accident; Analysis and Prevention
https://www.readbyqxmd.com/read/27912186/recycling-oriented-comparison-of-mercury-distribution-in-new-and-spent-fluorescent-lamps-and-their-potential-risk
#10
Julia Hobohm, Oliver Krüger, Srotoswini Basu, Kerstin Kuchta, Sebastian van Wasen, Christian Adam
This study compares the mercury distribution in the vapor phase, the phosphor powder and the glass matrix of new and spent fluorescent lamps. The spent fluorescent lamps were obtained at the collection yards of a public waste management company in Hamburg, Germany. An innovative systematic sampling method is utilized to collect six spent and eight corresponding new, off-the-shelf fluorescent lamp samples. The efficiency of several acid digestion methods for the determination of the elemental composition was studied and elemental mass fractions of K, Na, Y, Ca, Ba, Eu, Al, Pb, Mg, Hg, and P were measured...
November 29, 2016: Chemosphere
https://www.readbyqxmd.com/read/27911770/the-right-incentives-enable-ocean-sustainability-successes-and-provide-hope-for-the-future
#11
Jane Lubchenco, Elizabeth B Cerny-Chipman, Jessica N Reimer, Simon A Levin
Healthy ocean ecosystems are needed to sustain people and livelihoods and to achieve the United Nations Sustainable Development Goals. Using the ocean sustainably requires overcoming many formidable challenges: overfishing, climate change, ocean acidification, and pollution. Despite gloomy forecasts, there is reason for hope. New tools, practices, and partnerships are beginning to transform local fisheries, biodiversity conservation, and marine spatial planning. The challenge is to bring them to a global scale...
December 2, 2016: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/27910966/stem-cell-and-regenerative-medicine-global-conference-scrgc-2016-august-23-24-2016-gyeonggi-do-korea
#12
A Vertès
In its third edition, the Stem Cell and Regenerative Medicine Global Conference (SCRGC) organized by the Global Stem Cell & Regenerative Medicine Acceleration Center (GSRAC) was focused on breaking barriers to accelerate the pace of innovation and development of the regenerative medicine industry. GSRAC is both a think tank and a global network of key opinion leaders from the public and the private sectors. GSRAC was commissioned in 2011 by the Ministry of Health and Welfare (MOHW) of Korea. GSRAC's primary mission is to enable and accelerate the delivery of innovative technologies to patients who are affected by currently untreatable diseases...
October 2016: Drugs of Today
https://www.readbyqxmd.com/read/27909947/vaccine-rejecting-parents-engagement-with-expert-systems-that-inform-vaccination-programs
#13
Katie Attwell, Julie Leask, Samantha B Meyer, Philippa Rokkas, Paul Ward
In attempting to provide protection to individuals and communities, childhood immunization has benefits that far outweigh disease risks. However, some parents decide not to immunize their children with some or all vaccines for reasons including lack of trust in governments, health professionals, and vaccine manufacturers. This article employs a theoretical analysis of trust and distrust to explore how twenty-seven parents with a history of vaccine rejection in two Australian cities view the expert systems central to vaccination policy and practice...
December 1, 2016: Journal of Bioethical Inquiry
https://www.readbyqxmd.com/read/27909819/cost-effects-of-preterm-birth-a-comparison-of-health-care-costs-associated-with-early-preterm-late-preterm-and-full-term-birth-in-the-first-3%C3%A2-years-after-birth
#14
Josephine Jacob, Moritz Lehne, Andrea Mischker, Normen Klinger, Claudia Zickermann, Jochen Walker
Preterm birth is one of the main causes for infant morbidity and mortality. Apart from negative health outcomes, preterm birth also produces significant health care expenditures. This study evaluates the costs associated with preterm birth in different health sectors during the first 3 years of infants' lives. In a retrospective observational study based on claims data from a German statutory health insurance company, average costs for medication, hospital treatment, ambulatory treatment, and non-medical remedies during the first 3 years after birth were analyzed for early preterm, late preterm, and full-term births...
December 1, 2016: European Journal of Health Economics: HEPAC: Health Economics in Prevention and Care
https://www.readbyqxmd.com/read/27909641/a-case-series-of-complex-recalcitrant-wounds-treated-with-epidermal-grafts-harvested-from-an-automated-device
#15
Stephen S Cai, Arvind U Gowda, Karan Chopra, Rachel Waldman, Ronald P Silverman, Yvonne M Rasko
INTRODUCTION: Epidermal grafting has several advantages over full-thickness or split-thickness grafts in the treatment of complex non-healing wounds. These include the low risk of donor site complications, minimal patient discomfort, and abstention from the operating room. Traditionally, the lack of reliable epidermal harvesting techniques has limited its clinical utilization. The development of an automated suction blister epidermal graft (SBEG) harvesting device may facilitate clinical utilization of this technique...
October 30, 2016: Curēus
https://www.readbyqxmd.com/read/27909640/treating-fasciotomy-wounds-with-negative-pressure-wound-therapy-with-instillation-and-dwell-time-npwti-d
#16
Priscilla Lee
Acute compartment syndrome (ACS) is a serious complication of lower-extremity trauma caused by accidents or post-procedure complications. ACS is characterized by increased pressure within the compartment, resulting in reduced blood flow, tissue hypoxia, and tissue necrosis. Fasciotomies to relieve pressure and debridement of necrotic tissue comprise primary treatment. My purpose is to present initial experience using negative pressure wound therapy with instillation and dwell time (NPWTi-d)* to treat fasciotomy wounds in two patients...
October 28, 2016: Curēus
https://www.readbyqxmd.com/read/27909568/implementation-of-minimal-invasive-gynaecological-surgery-certification-will-challenge-gynaecologists-with-new-legal-and-ethical-issues
#17
V Tanos, R Socolov, P Demetriou, M Kyprianou, A Watrelot, Y Van Belle, R Campo
The introduction of a certification / diploma program in Minimal Invasive Surgery (MIS) is expected to improve surgical performance, patient's safety and outcome. The Gynaecological Endoscopic Surgical Education and Assessment programme (GESEA) and the ESHRE Certification for Reproductive Endoscopic Surgery (ECRES) provides a structured learning path, recognising different pillars of competence. In order to achieve a high level of competence a two steps validation is necessary: (a) the individual should be certified of having the appropriate theoretical knowledge and (b) the endoscopic psychomotor skills before entering in the diploma programme reflecting the surgical competence...
June 27, 2016: Facts, Views & Vision in ObGyn
https://www.readbyqxmd.com/read/27909155/extrapolation-techniques-evaluating-24-hours-of-average-electromagnetic-field-emitted-by-radio-base-station-installations-spectrum-analyzer-measurements-of-lte-and-umts-signals
#18
Stefano Mossetti, Daniela de Bartolo, Ivan Veronese, Marie Claire Cantone, Cristina Cosenza, Elisa Nava
International and national organizations have formulated guidelines establishing limits for occupational and residential electromagnetic field (EMF) exposure at high-frequency fields. Italian legislation fixed 20 V/m as a limit for public protection from exposure to EMFs in the frequency range 0.1 MHz-3 GHz and 6 V/m as a reference level. Recently, the law was changed and the reference level must now be evaluated as the 24-hour average value, instead of the previous highest 6 minutes in a day. The law refers to a technical guide (CEI 211-7/E published in 2013) for the extrapolation techniques that public authorities have to use when assessing exposure for compliance with limits...
December 1, 2016: Radiation Protection Dosimetry
https://www.readbyqxmd.com/read/27908874/tobacco-companies-consider-next-move-after-failing-to-overturn-plain-packaging-ruling
#19
Clare Dyer
No abstract text is available yet for this article.
December 1, 2016: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/27907901/serum-amh-levels-in-healthy-women-from-brca1-2-mutated-families-are-they-reduced
#20
Theodora C van Tilborg, Inge A P Derks-Smeets, Anna M E Bos, Jan C Oosterwijk, Ron J van Golde, Christine E de Die-Smulders, Lizet E van der Kolk, Wendy A G van Zelst-Stams, Maria E Velthuizen, Annemieke Hoek, Marinus J C Eijkemans, Joop S E Laven, Margreet G E M Ausems, Frank J M Broekmans
STUDY QUESTION: Do BRCA1/2 mutation carriers have a compromised ovarian reserve compared to proven non-carriers, based on serum anti-Müllerian hormone (AMH) levels? SUMMARY ANSWER: BRCA1/2 mutation carriers do not show a lower serum AMH level in comparison to proven non-carriers, after adjustment for potential confounders. WHAT IS KNOWN ALREADY: It has been suggested that the BRCA genes play a role in the process of ovarian reserve depletion, although previous studies have shown inconsistent results regarding the association between serum AMH levels and BRCA mutation status...
November 2016: Human Reproduction
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