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A Pruß
Transplantation of musculoskeletal tissues is widely used in the treatment of extensive defects of the musculoskeletal system, especially in orthopedics for exchange of prostheses, surgical interventions on the spine and in traumatology for reconstruction after extensive tumor resections. A danger after transplantation is the potential transmission of clinically relevant pathogens. Tissue banks have therefore established a safety level approach for musculoskeletal tissue transplants, which includes donor selection, laboratory testing, tissue procurement, tissue processing, tissue storage and quality assurance...
October 20, 2017: Der Unfallchirurg
Jake X Checketts, Matthew Thomas Sims, Matt Vassar
Importance: It is well documented that financial conflicts of interest influence medical research and clinical practice. Prior to the Open Payments provisions of the Affordable Care Act, financial ties became apparent only through self-disclosure. The nature of financial interests has not been studied among physicians who develop dermatology clinical practice guidelines. Objective: To evaluate payments received by physicians who author dermatology clinical practice guidelines, compare disclosure statements for accuracy, determine whether pharmaceutical companies from which the authors received payments manufactured products related to the guidelines, and examine the extent to which the American Academy of Dermatology enforced their Administrative Regulations for guideline development...
October 18, 2017: JAMA Dermatology
Cobin D Soelberg, Raeford E Brown, Derick Du Vivier, John E Meyer, Banu K Ramachandran
The United States is in the midst of a devastating opioid misuse epidemic leading to over 33,000 deaths per year from both prescription and illegal opioids. Roughly half of these deaths are attributable to prescription opioids. Federal and state governments have only recently begun to grasp the magnitude of this public health crisis. In 2016, the Centers for Disease Control and Prevention released their Guidelines for Prescribing Opioids for Chronic Pain. While not comprehensive in scope, these guidelines attempt to control and regulate opioid prescribing...
November 2017: Anesthesia and Analgesia
Keith T Veltri
Cardiovascular disease is the leading cause of morbidity and mortality in the United States. Patients who survive a primary cerebrovascular or cardiovascular event are at increased risk of a subsequent occurrence. Antiplatelet therapy plays an essential role for secondary prevention in individuals with stroke, transient ischemic attack, acute or chronic artery disease or peripheral arterial disease. Maintaining high risk patients on low dose aspirin therapy is a fundamental component of management. However, poor adherence, secondary to the drug's gastrointestinal side effects, has been associated with negative cardiovascular outcomes...
October 17, 2017: Cardiology in Review
Thomas Zahel, Stefan Hauer, Eric M Mueller, Patrick Murphy, Sandra Abad, Elena Vasilieva, Daniel Maurer, Cécile Brocard, Daniela Reinisch, Patrick Sagmeister, Christoph Herwig
During the regulatory requested process validation of pharmaceutical manufacturing processes, companies aim to identify, control, and continuously monitor process variation and its impact on critical quality attributes (CQAs) of the final product. It is difficult to directly connect the impact of single process parameters (PPs) to final product CQAs, especially in biopharmaceutical process development and production, where multiple unit operations are stacked together and interact with each other. Therefore, we want to present the application of Monte Carlo (MC) simulation using an integrated process model (IPM) that enables estimation of process capability even in early stages of process validation...
October 17, 2017: Bioengineering
Jana Gau, Jürgen Arnhold, Jörg Flemmig
OBJECTIVES: The enzyme lactoperoxidase (LPO), which is released into several body fluids like saliva, is an essential part to maintain the oral bacterial homeostasis by catalysing the oxidation of thiocyanate (SCN(-)) to hypo-thiocyanite ((-)OSCN). The formation of unreactive redox intermediates (like Compound II) leads to a decreased pseudo-halogenating enzyme activity, which is associated with a higher risk for oral infections. According to former studies with bovine LPO selected flavonoids were tested in respect to their potential to reactivate the enzymatic activity in a more physiological, human salivary system...
October 7, 2017: Archives of Oral Biology
Mozafar Khazaei, Atefe Ansarian, Elham Ghanbari
Royal jelly (RJ) is a natural bee product with great potential for use in medicine. The chemical composition of RJ indicates the presence of various bioactive substances including 10-hydroxydecanoic acid and 24-methylenecholesterol. In addition, a number of biological and pharmacological activities of RJ have been documented. The aim of this study was to review the biological and medical effects of RJ. The search was conducted in articles from electronic and scientific literature databases such as Pub Med, Science Direct, Scopus, Medline, and ISI Web of Science published from 1990 to 2017 using keywords of pharmacological, biological, and clinical effects and royal jelly...
October 13, 2017: Journal of Dietary Supplements
Abhirup Mookherjee, Shivangi Singh, Mrinal K Maiti
Endophytes are microbes which reside inside the plant tissues asymptomatically or causing pathogenicity to the host plant for a brief period. Owing to their presence in a specialized niche, endophytes are capable of synthesizing diverse types of bioactive molecules. Continuous development of resistance mechanism by pathogens to the currently available health treatments and pharmaceuticals has led researchers to explore new therapeutic agents. Quorum sensing has a role in the development of microbial pathogenic traits including biofilm formation...
October 12, 2017: Archives of Microbiology
Klemen Korasa, Franc Vrečer
Over the last two decades, regulatory agencies have demanded better understanding of pharmaceutical products and processes by implementing new technological approaches, such as process analytical technology (PAT). Process analysers present a key PAT tool, which enables effective process monitoring, and thus improved process control of medicinal product manufacturing. Process analysers applicable in pharmaceutical coating unit operations are comprehensibly described in the present article. The review is focused on monitoring of solid oral dosage forms during film coating in two most commonly used coating systems, i...
October 8, 2017: European Journal of Pharmaceutical Sciences
Piotr Latocha
The kiwiberry (Actinidia arguta) is a new product on the market that is enjoying growing consumer acceptance around the world. This widespread interest has created increased demand for identification of the kiwiberry's nutritional health benefits. Containing over 20 essential nutrients and a range of vitamins, the kiwiberry comes near the top of fruits classed as superfoods. It is one of the richest sources of vitamin C with up to 430 mg/100 g fresh weight (FW) and is considered the richest dietary source of myo-inositol (up to 982 mg/100 g FW)...
October 7, 2017: Plant Foods for Human Nutrition
Aparajith Bhaskar, Fernando N Barros, Ravendra Singh
In the context of continuous pharmaceutical oral dosage manufacturing, a control system is essential to ensure that the critical quality attributes (CQAs) are maintained within the regulatory constraints by mitigating variations generated in upstream operations. Such a system is essential to the Quality by Design (QbD) paradigm shift, which can ensure that predefined end quality attributes are achieved within an optimal economic and time bracket. In this work, an advanced model predictive control (MPC) architecture integrated with a novel real-time tablet weight measurement method has been development and implemented into a continuous direct compaction tablet manufacturing pilot-plant...
October 3, 2017: International Journal of Pharmaceutics
A Kuglstatter, M Stihle, C Neumann, C Müller, W Schaefer, C Klein, J Benz
An increasing number of bispecific therapeutic antibodies are progressing through clinical development. The Knob-into-Hole (KiH) technology uses complementary mutations in the CH3 region of the antibody Fc fragment to achieve heavy chain heterodimerization. Here we describe the X-ray crystal structures of glycosylated and disulfide-engineered heterodimeric KiH Fc fragment and its homodimeric Knob-Knob and Hole-Hole side products. The heterodimer structure confirms the KiH design principle and supports the hypothesis that glycosylation stabilizes a closed Fc conformation...
August 1, 2017: Protein Engineering, Design & Selection: PEDS
T Alvarino, S Suarez, J Lema, F Omil
New technologies for wastewater treatment have been developed in the last years based on the combination of biological reactors operating under different redox conditions. Their efficiency in the removal of organic micropollutants (OMPs) has not been clearly assessed yet. This review paper is focussed on understanding the sorption and biotransformation of a selected group of 17 OMPs, including pharmaceuticals, hormones and personal care products, during biological wastewater treatment processes. Apart from considering the role of "classical" operational parameters, new factors such as biomass conformation and particle size, upward velocity applied or the addition of adsorbents have been considered...
October 2, 2017: Science of the Total Environment
Monika Dymarska, Jakub Grzeszczuk, Monika Urbaniak, Tomasz Janeczko, Elżbieta Pląskowska, Łukasz Stępień, Edyta Kostrzewa-Susłow
Entomopathogenic fungi are known for their ability to carry out glycosylation of flavonoids, which usually results in the improvement of their stability and bioavailability. In this study we used a newly isolated strain of the entomopathogenic filamentous fungus Isaria fumosorosea KCH J2 as a biocatalyst. Our aim was to evaluate its ability to carry out the biotransformation of flavonoids and to obtain new flavonoid derivatives. The fungus was isolated from a spider's carcass and molecularly identified using analysis of the ITS1-ITS2 rDNA sequence...
2017: PloS One
Jérémy Merad, Claudia Lalli, Guillaume Bernadat, Julien Maury, Géraldine Masson
Synthesis of biologically active molecules (whether at laboratory or industrial scale) remains a highly appealing area of modern organic chemistry. Nowadays, the need to access original bioactive scaffolds goes together with the desire to improve synthetic efficiency while reducing the environmental footprint of chemical activities. Long neglected in the field of total synthesis, enantioselective organocatalysis has recently emerged as an eco-friendly and indispensable tool for the construction of relevant bioactive molecules...
October 5, 2017: Chemistry: a European Journal
Nazila Yousefi, Gholamhossein Mehralian, Hamid Reza Rasekh, Mina Yousefi
In today's competitive world, there are several strategies to deal with the fast changing environment, among which New product development (NPD) is a common strategy. However, almost half of the resources that companies devote to NPD are spent on products that may fail. This issue is particularly highlighted in the pharmaceutical industry mainly because of a long development-time, low success rate, high capital requirement, and market uncertainty. This study identifies critical success factors of NPD based on the relevant literatures and expert opinions in Iranian pharmaceutical industry, then prioritizes them using the methodology of multiple criteria decision making (MCDM) through analyzing 50 filled questionnaires structured based on the AHP (Analytical Hierarchy Process) approach...
2017: Iranian Journal of Pharmaceutical Research: IJPR
Jose R Cabrero-Antonino, Rosa Adam, Veronica Papa, Mattes Holsten, Kathrin Junge, Matthias Beller
The first general and efficient non-noble metal-catalysed reductive C2-alkoxylation of cyclic imides (phthalimides and succinimides) is presented. Crucial for the success is the use of [Co(BF4)2·6H2O/triphos (L1)] combination and no external additives are required. Using the optimal cobalt-system, the hydrogenation of the aromatic ring of the parent phthalimide is avoided and only one of the carbonyl groups is selectively functionalized. The resulting products, N- and aryl-ring substituted 3-alkoxy-2,3-dihydro-1H-isoindolin-1-one and N-substituted 3-alkoxy-pyrrolidin-2-one derivatives, are prepared under mild conditions in good to excellent isolated yields...
August 1, 2017: Chemical Science
S Poirier Larabie, M Houde, C Gagnon
Aquatic systems near major urban centers are constantly contaminated with effluent from wastewater treatment plants. Pharmaceuticals are part of the contamination and several classes of drugs have been detected in surface waters in the last decade. To better understand the impact of those pharmaceuticals in ecosystems, the exposure to aquatic species needs to be investigated. This study presents a new simple and rugged quantitative method for the determination of several classes of drugs using 100μL of plasma from fish environmentally exposed to a major but highly diluted urban effluent...
September 27, 2017: Journal of Chromatography. A
Jennifer Jo Thompson, Cheryl Ritenbaugh, Mark Nichter
BACKGROUND: In recent years, compounded bioidentical hormone therapy (CBHT) has emerged as a popular alternative to manufactured, FDA approved hormone therapy (HT)-despite concerns within the medical community and the availability of new FDA approved "bioidentical" products. This study aims to characterize the motivations for using CBHT in a U.S. sample of ordinary midlife women. METHODS: We analyze data collected from 21 current and former users of CBHT who participated in a larger qualitative study of menopausal decision-making among U...
October 2, 2017: BMC Women's Health
Mei-Ling Chen, Henning Blume, Gerald Beuerle, Barbara Davit, Mehul Mehta, Henrike Potthast, Barbara Schug, Yu Chung Tsang, Ralph-Steven Wedemeyer, Werner Weitschies, Jan Welink
Bioequivalence (BE) is considered one of the key questions in new and generic drug product development and registration worldwide. However, the regulations and jurisdiction vary from country to country and continent to continent. Harmonization of regulatory requirements and criteria for BE determination may avoid unnecessary repetition of BE studies and minimize drug exposure to humans. Harmonization around the globe may be achieved by a better understanding of scientific principles and expectations from different regulatory authorities...
September 28, 2017: European Journal of Pharmaceutical Sciences
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