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https://www.readbyqxmd.com/read/28738570/determination-of-selected-bisphenols-parabens-and-estrogens-in-human-plasma-using-lc-ms-ms
#1
Lucie Kolatorova Sosvorova, Tereza Chlupacova, Jana Vitku, Martin Vlk, Jiri Heracek, Luboslav Starka, David Saman, Marketa Simkova, Richard Hampl
In this study, a novel liquid chromatography - tandem mass spectrometry method for the simultaneous determination of bisphenols (BPA, BPS, BPF, BPAF), parabens (methyl-, ethyl-, propyl-, butyl-, benzyl-paraben) and estrogens (estrone, estradiol, estriol) in human plasma is presented. Since all analytes possess the phenolic group, dansyl chloride derivatization was applied in order to gain high sensitivity. The method was validated according to FDA guidelines, and all validation requirements were satisfactory...
November 1, 2017: Talanta
https://www.readbyqxmd.com/read/28738096/the-placebo-effect-and-its-clinical-associations-in-gambling-disorder
#2
Jon E Grant, Samuel R Chamberlain
BACKGROUND: Although gambling disorder is prevalent and functionally impairing, no FDA-approved medications exist for its treatment. The ability of clinical trials to detect the benefits of active treatment has been hindered by an unusually high placebo response. Virtually nothing is known about baseline clinical characteristics that might predict placebo response in those with gambling disorder. METHODS: Participants (N = 152) assigned to placebo were pooled from multiple double-blind trials of gambling disorder...
August 2017: Annals of Clinical Psychiatry: Official Journal of the American Academy of Clinical Psychiatrists
https://www.readbyqxmd.com/read/28738091/the-second-window-icg-technique-demonstrates-a-broad-plateau-period-for-near-infrared-fluorescence-tumor-contrast-in-glioblastoma
#3
Ryan Zeh, Saad Sheikh, Leilei Xia, John Pierce, Andrew Newton, Jarrod Predina, Steve Cho, MacLean Nasrallah, Sunil Singhal, Jay Dorsey, John Y K Lee
INTRODUCTION: Fluorescence-guided surgery has emerged as a powerful tool to detect, localize and resect tumors in the operative setting. Our laboratory has pioneered a novel way to administer an FDA-approved near-infrared (NIR) contrast agent to help surgeons with this task. This technique, coined Second Window ICG, exploits the natural permeability of tumor vasculature and its poor clearance to deliver high doses of indocyanine green (ICG) to tumors. This technique differs substantially from established ICG video angiography techniques that visualize ICG within minutes of injection...
2017: PloS One
https://www.readbyqxmd.com/read/28737946/structure-guided-optimization-of-hiv-integrase-strand-transfer-inhibitors
#4
Xue Zhi Zhao, Steven J Smith, Daniel P Maskell, Mathieu Métifiot, Valerie E Pye, Katherine Fesen, Christophe Marchand, Yves Pommier, Peter Cherepanov, Stephen H Hughes, Terrence R Burke
Integrase mutations can reduce effectiveness of the first-generation FDA-approved integrase strand transfer inhibitors (INSTIs), raltegravir (RAL) and elvitegravir (EVG). The second-generation agent, dolutegravir (DTG) has enjoyed considerable clinical success; however, resistance-causing mutations that diminish the efficacy of DTG have appeared. Our current findings support and extend the substrate envelope concept that broadly effective INSTIs can be designed by filling the envelope defined by the DNA substrates...
July 24, 2017: Journal of Medicinal Chemistry
https://www.readbyqxmd.com/read/28737885/classics-in-chemical-neuroscience-memantine
#5
Shahrina Alam, Kaelyn Skye Lingenfelter, Aaron M Bender, Craig W Lindsley
Memantine was the first breakthrough medication for the treatment of moderate to severe Alzheimer's disease (AD) patients, and represents a fundamentally new mechanism of action (moderate-affinity, uncompetitive, voltage-dependent, N-methyl-D-aspartate (NMDA) receptor antagonist that exhibits fast on/off kinetics) to modulate glutamatergic dysfunction. Since its approval by the FDA in 2003, memantine, alone, and in combination with donepezil, has improved patient outcomes in terms of cognition, behavioral disturbances, daily functioning and delaying time to institutionalization...
July 24, 2017: ACS Chemical Neuroscience
https://www.readbyqxmd.com/read/28737743/development-of-gene-therapies-lessons-from-nusinersen
#6
REVIEW
L Xu, I Irony, W W Bryan, B Dunn
The nusinersen development and approval process provide important lessons regarding the pathway to marketing approval for gene therapies. These lessons emphasize rigorous clinical trial design, flexibility in trial design and analysis, a collaborative effort with regular communications between the drug developer and the FDA, and use of FDA's expedited programs. These lessons are critical to the development of gene therapies for the treatment of serious or life-threatening rare diseases.Gene Therapy accepted article preview online, 24 July 2017...
July 24, 2017: Gene Therapy
https://www.readbyqxmd.com/read/28737730/sildenafil-in-infants-and-children
#7
REVIEW
Larisa Simonca, Robert Tulloh
Pulmonary arterial hypertension (PAH) management has been transformed in recent times with the advent of cheap and effective diagnostic tools and therapy. Sildenafil, a phosphodiesterase-V inhibitor, has been at the centre of this treatment, and its success in treating PAH has led to its widespread uptake in adult and paediatric pulmonary hypertension (PH), as a first line treatment choice. This might apply to persistent pulmonary hypertension of the newborn (PPHN) or bronchopulmonary dysplasia, as well as to more complex diseases, such as idiopathic pulmonary hypertension...
July 24, 2017: Children
https://www.readbyqxmd.com/read/28737679/modernization-of-enoxaparin-molecular-weight-determination-using-homogeneous-standards
#8
Katelyn M Arnold, Stephen J Capuzzi, Yongmei Xu, Eugene N Muratov, Kevin Carrick, Anita Y Szajek, Alexander Tropsha, Jian Liu
Enoxaparin is a low-molecular weight heparin used to treat thrombotic disorders. Following the fatal contamination of the heparin supply chain in 2007-2008, the U.S. Pharmacopeia (USP) and U.S. Food and Drug Administration (FDA) have worked extensively to modernize the unfractionated heparin and enoxaparin monographs. As a result, the determination of molecular weight (MW) has been added to the monograph as a measure to strengthen the quality testing and to increase the protection of the global supply of this life-saving drug...
July 22, 2017: Pharmaceuticals
https://www.readbyqxmd.com/read/28737432/integrin-targeted-nano-sized-polymeric-systems-for-paclitaxel-conjugation-a-comparative-study
#9
Anat Eldar-Boock, Rachel Blau, Claudia Ryppa, Hemda Baabur-Cohen, Ariel Many, María J Vicent, Felix Kratz, Joaquin Sanchis, Ronit Satchi-Fainaro
The generation of rationally-designed polymer therapeutics via the conjugation of low molecular weight anti-cancer drugs to water-soluble polymeric nanocarriers aims to improve the therapeutic index. Here, we focus on applying polymer therapeutics to target two cell compartments simultaneously - tumor cells and angiogenic endothelial cells. Comparing different polymeric backbones carrying the same therapeutic agent and targeting moiety may shed light on any correlation between the choice of polymer and the anti-cancer activity of the conjugate...
July 24, 2017: Journal of Drug Targeting
https://www.readbyqxmd.com/read/28736981/ketoacidosis-and-sglt2-inhibitor-treatment-analysis-of-faers-data
#10
Jenny E Blau, Sri Harsha Tella, Simeon I Taylor, Kristina I Rother
BACKGROUND: Regulatory agencies have concluded that sodium glucose cotransporter 2 (SGLT2) inhibitors lead to ketoacidosis, but published literature on this point remains controversial. METHODS: We searched the FDA Adverse Event Reporting System (FAERS) for reports of acidosis in patients treated with canagliflozin, dapagliflozin, or empagliflozin (from the date of each drug's FDA approval until May 15, 2015). We compared the number of SGLT2 inhibitor-related reports to reports of acidosis in patients treated with the two most commonly used DPP4 inhibitors: sitagliptin and saxagliptin...
July 24, 2017: Diabetes/metabolism Research and Reviews
https://www.readbyqxmd.com/read/28736939/fetal-hemoglobin-in-sickle-cell-anemia-the-arab-indian-haplotype-and-new-therapeutic-agents
#11
REVIEW
Alawi H Habara, Elmutaz M Shaikho, Martin H Steinberg
Fetal hemoglobin (HbF) has well-known tempering effects on the symptoms of sickle cell disease and its levels vary among patients with different haplotypes of the sickle hemoglobin gene. Compared with sickle cell anemia haplotypes found in patients of African descent, HbF levels in Saudi and Indian patients with the Arab-Indian (AI) haplotype exceed that in any other haplotype by nearly two-fold. Genetic association studies have identified some loci associated with high HbF in the AI haplotype but these observations require functional confirmation...
July 24, 2017: American Journal of Hematology
https://www.readbyqxmd.com/read/28736661/brain-tumor-delineation-enhanced-by-moxifloxacin-based-two-photon-cars-combined-microscopy
#12
Viet-Hoan Le, Su Woong Yoo, Yeoreum Yoon, Taejun Wang, Bumju Kim, Seunghun Lee, Kyung-Hwa Lee, Ki Hean Kim, Euiheon Chung
Delineating brain tumor margin is critical for maximizing tumor removal while sparing adjacent normal tissue for better clinical outcome. We describe the use of moxifloxacin-based two-photon (TP)/coherent anti-Stokes Raman scattering (CARS) combined microscopy for differentiating normal mouse brain tissue from metastatic brain tumor tissue based on histoarchitectural and biochemical differences. Moxifloxacin, an FDA-approved compound, was used to label cells in the brain, and moxifloxacin-based two-photon microscopy (TPM) revealed tumor lesions with significantly high cellular density and invading edges in a metastatic brain tumor model...
April 1, 2017: Biomedical Optics Express
https://www.readbyqxmd.com/read/28736633/biologics-in-gastrointestinal-and-pancreatic-neuroendocrine-tumors
#13
REVIEW
Iris H Liu, Pamela L Kunz
The development of biologic agents has ushered in a new era of precision medicine, opening the door to new therapeutic options designed to intelligently target cancer cells and their promoting factors, while leaving normal cells relatively unharmed. Biologics for the treatment of neuroendocrine tumors (NETs) have followed in the footsteps of regimens targeting pathways upregulated in other cancers, including the vascular endothelial growth factor (VEGF) and the mammalian target of rapamycin (mTOR). Through a number of clinical trials, the mTOR inhibitor everolimus and the receptor tyrosine kinase (RTK) inhibitor sunitinib were recently approved for NETs...
June 2017: Journal of Gastrointestinal Oncology
https://www.readbyqxmd.com/read/28736627/personalized-and-precision-medicine-integrating-genomics-into-treatment-decisions-in-gastrointestinal-malignancies
#14
REVIEW
Trang H Au, Kai Wang, David Stenehjem, Ignacio Garrido-Laguna
The advent of next generation sequencing (NGS) technologies has advanced our understanding of the intrinsic biology of different gastrointestinal (GI) tumor types. The use of novel, more efficient sequencing platforms has improved turnaround times of sequencing results. This is providing real time opportunities to put precision medicine to the test. A number of early phase clinical trials are testing targeted therapies in unique molecularly characterized subsets of patients (baskets). While basket studies are gaining momentum, treatment failures serve to remind us that shifting from a histology-driven to a histology-agnostic approach is unlikely to be a failure-free strategy for a number of tumor types as recently learnt from vemurafenib failure in BRAF mutated metastatic colorectal cancer (mCRC)...
June 2017: Journal of Gastrointestinal Oncology
https://www.readbyqxmd.com/read/28733750/magnetic-surgery-first-u-s-experience-with-a-novel-device
#15
Ivy N Haskins, Andrew T Strong, Matthew T Allemang, Kalman P Bencsath, John H Rodriguez, Matthew D Kroh
INTRODUCTION: Magnet-assisted surgery is a new platform within minimally invasive surgery. The Levita™ Magnetic Surgical System, the first magnetic surgical system to receive Food and Drug Administration (FDA) approval, includes a deployable, magnetic grasper and an external magnet that is used to manipulate the grasper within the peritoneal cavity. This system is currently approved for patients undergoing laparoscopic cholecystectomy with a body mass index (BMI) between 21 and 34 kg/m(2)...
July 21, 2017: Surgical Endoscopy
https://www.readbyqxmd.com/read/28732306/photostability-testing-using-online-reactor-hplc-hyphenation-and-mass-spectrometric-compound-identification-illustrated-by-ketoprofen-as-model-compound
#16
Jaber Assaf, Diego Zulkiewicz Gomes, Bernhard Wuest, Maria Kristina Parr
Investigations on the photochemical stability of pharmaceutical substances are mandatory in drug development and licensing as photo-induced degradation of an active pharmaceutical ingredient (API) may not only lead to decreased API concentrations but also to toxic or reactive products. Thus, the US Food and Drug Administration (FDA) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued Guidance for Industry Q1B "Photostability Testing of New Drug Substances and Products" for testing of pure but also packed drugs...
July 8, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28732278/advances-of-small-molecule-targeting-of-kinases
#17
REVIEW
Norbert Berndt, Rezaul M Karim, Ernst Schönbrunn
Reversible protein phosphorylation regulates virtually all aspects of life in the cell. As a result, dysregulation of protein kinases, the enzymes responsible for transferring phosphate groups from ATP to proteins, are often the cause or consequence of many human diseases including cancer. Almost three dozen protein kinase inhibitors (PKIs) have been approved for clinical applications since 1995, the vast majority of them for the treatment of cancer. According to the NCI, there are more than 100 types of cancer...
July 18, 2017: Current Opinion in Chemical Biology
https://www.readbyqxmd.com/read/28731350/gastric-and-duodenal-ethanol-concentrations-after-intake-of-alcoholic-beverages-in-postprandial-conditions
#18
Jari Rubbens, Danny Riethorst, Joachim Brouwers, Kris Wolfs, Erwin Adams, Jan Tack, Patrick Augustijns
INTRODUCTION: This study determined intraluminal ethanol concentrations (stomach and duodenum) in fed healthy volunteers after the consumption of common alcoholic beverages (beer, wine and whisky). The results of this study were compared with a previous study in fasted volunteers. MATERIALS AND METHODS: Five healthy volunteers were recruited in a cross-over study. The fed state was simulated by ingestion of 250 mL of Nutridrink Compact® Neutral. Volunteers subsequently consumed two standard units of beer (Stella Artois®, 500 mL, 5...
July 21, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28731221/evaluating-the-renal-safety-of-investigational-new-drugs-where-should-we-be-going
#19
N Stockbridge, M Blank, E A Hausner, A Thompson
We the authors work in the US Food and Drug Administration (FDA) review division responsible for the therapeutic agents for primary renal disease. We also field consultative inquiries regarding off-target adverse renal effects of drugs intended to treat other diseases. We do neither basic science research on renal diseases nor clinical studies of new drugs, but we are professional spectators of both. We offer here our thoughts on the challenge of identifying renal safety signals in the preclinical space and in the earliest phases of clinical development...
July 21, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28730936/an-industry-update-what-is-the-latest-news-in-therapeutic-delivery
#20
Iain Simpson
This Industry Update covers the period from 1 through 30 April 2017, and is based on information sourced from company press releases, scientific literature, patents and various news websites. Biogen expanded its portfolio of developmental drugs targeting neurological diseases by licensing a drug from Bristol-Myers Squibb which is currently under investigation for the treatment of progressive supranuclear palsy. Takeda announced a deal with NuBiyota focused on developing treatments for gastrointestinal disorders, based on the manipulation of microbes living in the gut...
July 2017: Therapeutic Delivery
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