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https://www.readbyqxmd.com/read/29792985/novel-excipients-regulatory-challenges-and-perspectives-the-eu-insight
#1
Piotr Kozarewicz, Thorsteinn Loftsson
Novel excipients are indispensable in development of modern, advanced drug delivery systems and biotechnology-derived drugs. Although numerous novel excipients are developed for pharmaceutical use, they are not frequently seen in medicinal products due to the strict regulatory requirements and perception that their use makes new product evaluation more complex with risk of delays in the approval process. Regulators regard novel excipients as new substances and whenever new excipient is used in a formulation it must be subjected to full evaluation, similarly to the one required for new active substance...
May 21, 2018: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/29792967/validated-reverse-phase-hplc-diode-array-method-for-the-quantification-of-intact-bevacizumab-infliximab-and-trastuzumab-for-long-term-stability-study
#2
Antonio Martínez-Ortega, Agustín Herrera, Antonio Salmerón-García, José Cabeza, Luis Cuadros-Rodríguez, Natalia Navas
The aim of the present study was to develop suitable and reliable method for quantification three of the most worldwide used therapeutic monoclonal antibodies (mAbs) -bevazizumab (BVZ), infliximab (INF) and trastuzumab (TTZ)- to be used in long-term stability studies. Reverse phase (RP) was selected by its greater sensibility and reproducibility comparing with other chromatographic modes. Then a high performance liquid chromatography with diode array detection (RP)HPLC/DAD method was checked. Since the three mAbs represent the active ingredient in the medicines in which they are formulated, the selected method was validated for each one in accordance with the International Conference on Harmonization (ICH) guidelines for pharmaceuticals for human use...
May 21, 2018: International Journal of Biological Macromolecules
https://www.readbyqxmd.com/read/29792820/hydrogel-tissue-chemistry-principles-and-applications
#3
Viviana Gradinaru, Jennifer Treweek, Kristin Overton, Karl Deisseroth
Over the past five years, a rapidly developing experimental approach has enabled high-resolution and high-content information retrieval from intact multicellular animal (metazoan) systems. New chemical and physical forms are created in the hydrogel-tissue chemistry process, and the retention and retrieval of crucial phenotypic information regarding constituent cells and molecules (and their joint interrelationships) are thereby enabled. For example, rich data sets defining both single-cell-resolution gene expression and single-cell-resolution activity during behavior can now be collected while still preserving information on three-dimensional positioning and/or brain-wide wiring of those very same neurons-even within vertebrate brains...
May 20, 2018: Annual Review of Biophysics
https://www.readbyqxmd.com/read/29792720/-experimental-processing-of-corrosion-casts-of-large-animal-organs
#4
R Pálek, V Liška, L Eberlová, H Mírka, M Svoboda, S Haviar, M Emingr, O Brzoň, P Mik, V Třeška
INTRODUCTION: Corrosion casts (CCs) are used for the visualization and assessment of hollow structures. CCs with filled capillaries enable (with the help of imaging methods) to obtain data for mathematical organ perfusion modelling. As the processing is more difficult in case of organs with greater volume of the vasculature, mainly organs from small animals have been cast up to now. The aim of this study was to optimize the protocol of corrosion casting of different organs of pig. Porcine organs are relatively easily accessible and frequently used in experimental medicine...
2018: Rozhledy V Chirurgii: Měsíčník Československé Chirurgické Společnosti
https://www.readbyqxmd.com/read/29792698/site-selective-switching-strategies-to-functionalize-polyazines
#5
Ryan D Dolewski, Patrick J Fricke, Andrew McNally
Many drug fragments and therapeutic compounds contain multiple pyridines and diazines. Developing site-selective reactions where specific C-H bonds can be transformed in polyazine structures would enable rapid access to valuable derivatives. We present a study that addresses this challenge by selectively installing a phosphonium ion as a versatile functional handle. Inherent factors that control site-selectivity are described along with mechanistically driven approaches for site-selective switching, where the C-+PPh3 group can be predictably installed at other positions in the polyazine system...
May 24, 2018: Journal of the American Chemical Society
https://www.readbyqxmd.com/read/29792579/effects-of-essential-oil-from-thymus-vulgaris-on-viability-and-inflammation-in-zebrafish-embryos
#6
Katherine M Polednik, Abby C Koch, Lisa K Felzien
Innate immunity provides the initial response against pathogens and includes the inflammatory response. Regulation of the initiation and duration of neutrophil and mononuclear cell influx during inflammation determines both the successfulness of pathogen elimination and the level of resulting tissue damage. Zebrafish embryos provide excellent opportunities to visualize the inflammatory response. Neutrophil granules may be stained with Sudan black, and variation in neutrophil counts may be used to monitor the level of the response...
May 24, 2018: Zebrafish
https://www.readbyqxmd.com/read/29792163/different-patterns-of-inflammatory-and-angiogenic-factors-are-associated-with-peritoneal-small-solute-transport-and-peritoneal-protein-clearance-in-peritoneal-dialysis-patients
#7
Yuanyuan Shi, Hao Yan, Jiangzi Yuan, He Zhang, Jiaying Huang, Zhaohui Ni, Jiaqi Qian, Wei Fang
BACKGROUND: Both peritoneal small solute transport and peritoneal protein clearance are closely linked to outcomes in peritoneal dialysis (PD) patients. However, the associated factors of these two components are not fully understood so far. This study aimed to investigate the association between a panel of systemic and peritoneal inflammatory and angiogenic factors and peritoneal solute transport properties. METHODS: Stable PD patients in PD center of Renji Hospital, School of Medicine, Shanghai Jiao Tong University were enrolled in present study...
May 23, 2018: BMC Nephrology
https://www.readbyqxmd.com/read/29791610/what-do-cochrane-systematic-reviews-say-about-cardiac-arrest-management
#8
Rafael Leite Pacheco, Juliana Trevizo, Caio Augusto de Souza, Gabriel Alves, Bruno Sakaya, Luciana Thiago, Aécio Flávio Teixeira de Góis, Rachel Riera
CONTEXT AND OBJECTIVE: Cardiac arrest is associated with high morbidity and mortality and imposes a significant burden on the healthcare system. Management of cardiac arrest patients is complex and involves approaches with multiple interventions. Here, we aimed to summarize the available evidence regarding the interventions used in cardiac arrest cases. DESIGN AND SETTING: Review of systematic reviews (SRs), conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo...
March 2018: São Paulo Medical Journal, Revista Paulista de Medicina
https://www.readbyqxmd.com/read/29791243/amcp-partnership-forum-managing-care-in-the-wave-of-precision-medicine
#9
(no author information available yet)
Precision medicine, the customization of health care to an individual's genetic profile while accounting for biomarkers and lifestyle, has increasingly been adopted by health care stakeholders to guide the development of treatment options, improve treatment decision making, provide more patient-centered care, and better inform coverage and reimbursement decisions. Despite these benefits, key challenges prevent its broader use and adoption. On December 7-8, 2017, the Academy of Managed Care Pharmacy convened a group of stakeholders to discuss these challenges and provide recommendations to facilitate broader adoption and use of precision medicine across health care settings...
May 23, 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29791132/ptml-model-of-chembl-data-for-dopamine-targets-docking-synthesis-and-assay-of-new-plg-peptidomimetics
#10
Joana Ferreira da Costa, David Silva, Olga Caamaño, José M Brea, Maria Isabel Loza, Cristian R Munteanu, Alejandro Pazos, Xerardo García-Mera, Humbert González-Díaz
Predicting Drug-Protein Interactions (DPIs) for target proteins involved in Dopamine pathways is very important goal in medicinal chemistry. We can tackle this problem using Molecular Docking or Machine Learning (ML) models for one specific protein. Unfortunately, these models fail to account for large and complex Big Data sets of preclinical assays reported in public databases. This includes multiple conditions of assay like different experimental parameters, biological assays, target proteins, cell lines, organism of the target, organism of assay, etc...
May 23, 2018: ACS Chemical Neuroscience
https://www.readbyqxmd.com/read/29790691/the-protective-effect-of-gingko-biloba-in-a-rat-model-of-ovarian-ischemia-reperfusion-injury-improvement-in-histological-and-biochemical-parameters
#11
Nuri Yildirim, Deniz Simsek, Semir Kose, Alkim Gulsah Sahingoz Yildirim, Cagri Guven, Gurkan Yigitturk, Oytun Erbas
BACKGROUND: Ovarian torsion is one of the most common gynecological emergencies, which especially affects women of reproductive age. OBJECTIVES: We aimed to evaluate the effect of Ginkgo biloba (GB) supplementation in ovarian ischemia/ reperfusion injury in an experimental torsion/de-torsion rat model. MATERIAL AND METHODS: This study was carried out in the Ege University Faculty of Medicine in Izmir, Turkey. Thirty mature female Sprague-Dawley albino rats were randomly divided into 5 groups: in Group 1 (control), the abdominal wall was only opened and closed; in the torsion group (Group 2), ischemia was induced for 3 h, using atraumatic vascular clips to create a torsion model; in the torsion/GB group (Group 3), the rats were given 80 mg/kg (oral gavage) of GB 30 min before torsion was induced and the torsion model was formed; in the torsion/de-torsion group (Group 4), the rats underwent 3 h of ischemia and then the vascular clips were removed and reperfusion took place for 3 h; in the torsion/de-torsion/GB group (Group 5), the rats underwent 3 h of ischemia followed by GB (oral gavage) 30 min prior to a 3-h reperfusion period...
May 16, 2018: Advances in Clinical and Experimental Medicine: Official Organ Wroclaw Medical University
https://www.readbyqxmd.com/read/29790688/loganic-acid-and-anthocyanins-from-cornelian-cherry-cornus-mas-l-fruits-modulate-diet-induced-atherosclerosis-and-redox-status-in-rabbits
#12
Tomasz Sozański, Alicja Z Kucharska, Stanisław Dzimira, Jan Magdalan, Dorota Szumny, Agnieszka Matuszewska, Beata Nowak, Narcyz Piórecki, Adam Szeląg, Małgorzata Trocha
BACKGROUND: Cornelian cherry (Cornus mas L.) is a plant growing in southeast Europe, in the past used in folk medicine. There are many previous publications showing the preventive effects of (poly)phenolic compounds, especially anthocyanins, on cardiovascular diseases, but there is a lack of studies comparing the effects of (poly)phenolics and other constituents of fruits. OBJECTIVES: We have attempted to determine if iridoids and anthocyanins from cornelian cherry fruits may affect the formation of atherosclerotic plaques in the aorta as well as lipid peroxidation and oxidative stress in the livers of cholesterol-fed rabbits...
April 25, 2018: Advances in Clinical and Experimental Medicine: Official Organ Wroclaw Medical University
https://www.readbyqxmd.com/read/29790360/-current-and-future-pharmacotherapy-of-severe-psychiatric-disorders
#13
Eva Češková
Despite of tremendous development in CNS research, current treatment is suboptimal especially in severe mental disorders. In medicine, there are two main methods of improving the healthcare provided: seeking new treatment procedures and perfecting (optimizing) the existing ones. Optimization of treatment includes not only practical tools such as therapeutic drug monitoring, but also implementation of general trends into the clinical practice. New pharmacological options include drugs aimed at other than monoaminergic systems and old drugs used before the psychopharmacological era...
2018: Casopís Lékar̆ů C̆eských
https://www.readbyqxmd.com/read/29790062/analysis-of-pulse-signals-based-on-array-pulse-volume
#14
Ji Cui, Li-Ping Tu, Jian-Feng Zhang, Shao-Liang Zhang, Zhi-Feng Zhang, Jia-Tuo Xu
OBJECTIVE: To collect and analyze multi-dimensional pulse diagram features with the array sensor of a pressure profile system (PPS) and study the characteristic parameters of the new multi-dimensional pulse diagram by pulse diagram analysis technology. METHODS: The pulse signals at the Guan position of left wrist were acquired from 105 volunteers at the Shanghai University of Traditional Chinese Medicine. We obtained the pulse data using an array sensor with 3×4 channels...
May 22, 2018: Chinese Journal of Integrative Medicine
https://www.readbyqxmd.com/read/29789665/existing-and-novel-biomarkers-for-precision-medicine-in-systemic-sclerosis
#15
REVIEW
Peter J Wermuth, Sonsoles Piera-Velazquez, Joel Rosenbloom, Sergio A Jimenez
The discovery and validation of biomarkers resulting from technological advances in the analysis of genomic, transcriptomic, lipidomic and metabolomic pathways involved in the pathogenesis of complex human diseases have led to the development of personalized and rationally designed approaches for the clinical management of such disorders. Although some of these approaches have been applied to systemic sclerosis (SSc), an unmet need remains for validated, non-invasive biomarkers to aid in the diagnosis of SSc, as well as in the assessment of disease progression and response to therapeutic interventions...
May 22, 2018: Nature Reviews. Rheumatology
https://www.readbyqxmd.com/read/29789647/microbial-production-of-novel-sulphated-alkaloids-for-drug-discovery
#16
Eitaro Matsumura, Akira Nakagawa, Yusuke Tomabechi, Shinichi Ikushiro, Toshiyuki Sakaki, Takane Katayama, Kenji Yamamoto, Hidehiko Kumagai, Fumihiko Sato, Hiromichi Minami
Natural products from plants are useful as lead compounds in drug discovery. Plant benzylisoquinoline alkaloids (BIAs) exhibit various pharmaceutical activities. Although unidentified BIAs are expected to be of medicinal value, sufficient quantities of such BIAs, for biological assays, are sometimes difficult to obtain due to their low content in natural sources. Here, we showed that high productivity of BIAs in engineered Escherichia coli could be exploited for drug discovery. First, we improved upon the previous microbial production system producing (S)-reticuline, an important BIA intermediate, to obtain yields of around 160 mg/L, which was 4-fold higher than those of the previously reported highest production system...
May 22, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29789468/in-vitro-evaluation-of-2d-printed-edible-films-for-the-buccal-delivery-of-diclofenac-sodium
#17
Georgios K Eleftheriadis, Paraskevi Kyriaki Monou, Nikolaos Bouropoulos, Dimitrios G Fatouros
Printing technologies have recently emerged in the development of novel drug delivery systems toward personalized medicine, to improve the performance of formulations, existing bioavailability patterns, and patients' compliance. In the context of two-dimensional printing, this article presents the development of buccal films that are designed to efficiently deliver a class II compound (diclofenac sodium), according to the Biopharmaceutics Classification System (BCS), to the oral cavity. The preparation of drug-loaded inks was carried out based on solubility studies and evaluation of rheological properties, combining ethanol and propylene glycol as optimal solvents...
May 22, 2018: Materials
https://www.readbyqxmd.com/read/29789364/bacterial-quorum-sensing-and-microbial-community-interactions
#18
REVIEW
Rhea G Abisado, Saida Benomar, Jennifer R Klaus, Ajai A Dandekar, Josephine R Chandler
Many bacteria use a cell-cell communication system called quorum sensing to coordinate population density-dependent changes in behavior. Quorum sensing involves production of and response to diffusible or secreted signals, which can vary substantially across different types of bacteria. In many species, quorum sensing modulates virulence functions and is important for pathogenesis. Over the past half-century, there has been a significant accumulation of knowledge of the molecular mechanisms, signal structures, gene regulons, and behavioral responses associated with quorum-sensing systems in diverse bacteria...
May 22, 2018: MBio
https://www.readbyqxmd.com/read/29788979/marcks-and-marcks-like-proteins-in-development-and-regeneration
#19
REVIEW
Mohamed El Amri, Una Fitzgerald, Gerhard Schlosser
BACKGROUND: The Myristoylated Alanine-Rich C-kinase Substrate (MARCKS) and MARCKS-like protein 1 (MARCKSL1) have a wide range of functions, ranging from roles in embryonic development to adult brain plasticity and the inflammatory response. Recently, both proteins have also been identified as important players in regeneration. Upon phosphorylation by protein kinase C (PKC) or calcium-dependent calmodulin-binding, MARCKS and MARCKSL1 translocate from the membrane into the cytosol, modulating cytoskeletal actin dynamics and vesicular trafficking and activating various signal transduction pathways...
May 22, 2018: Journal of Biomedical Science
https://www.readbyqxmd.com/read/29788906/influences-on-the-adoption-of-patient-safety-innovation-in-primary-care-a-qualitative-exploration-of-staff-perspectives
#20
Ian Litchfield, Paramjit Gill, Tony Avery, Stephen Campbell, Katherine Perryman, Kate Marsden, Sheila Greenfield
BACKGROUND: Primary care is changing rapidly to meet the needs of an ageing and chronically ill population. New ways of working are called for yet the introduction of innovative service interventions is complicated by organisational challenges arising from its scale and diversity and the growing complexity of patients and their care. One such intervention is the multi-strand, single platform, Patient Safety Toolkit developed to help practices provide safer care in this dynamic and pressured environment where the likelihood of adverse incidents is increasing...
May 22, 2018: BMC Family Practice
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