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https://www.readbyqxmd.com/read/28230974/femtogram-resolution-of-iron-content-on-a-per-cell-basis-ex-vivo-storage-of-human-red-blood-cells-leads-to-loss-of-hemoglobin
#1
Jeffrey J Chalmers, Xiaoxia Jin, Andre Francis Palmer, Peter Amaya, Mark H Yazer, Lee R Moore, Kyoung-Joo Park, X Jeff Pan, Maciej Zborowski
The magnetic characteristics of hemoglobin (Hb) changes with the binding of dioxygen (O2) to the heme prosthetic groups of the globin chains: from paramagnetic ferrous Hb to diamagnetic ferrous oxyhemoglobin (oxyHb) with reversibly bound O2, or paramagnetic ferric methemoglobin (metHb). When multiplied over the number of Hb molecules in a red blood cell (RBC), the effect is detectable through motion analysis of RBCs in a high magnetic field and gradient. This motion is referred to as magnetophoretic mobility which can be conveniently expressed as a fraction of the cell sedimentation coefficient...
February 23, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28230687/fda-promotes-safe-use-of-otc-medications
#2
Diane S Aschenbrenner
No abstract text is available yet for this article.
March 2017: American Journal of Nursing
https://www.readbyqxmd.com/read/28230456/off-label-prescribing-for-children-with-migraines-in-u-s-ambulatory-care-settings
#3
L Leanne Lai, Leroy Koh, Jane Ai-Chen Ho, Alexander Ting, Augustine Obi
BACKGROUND: Migraines, Which Affect About 10% Of School-Age Children In The United States, Can Significantly Impair Quality Of Life. Despite Potential Disability, Many Children Do Not Receive Treatment Or Prophylaxis, Since Medications Specifically Approved For Children Are Significantly Less Than For Adults. There Is Also Controversy Surrounding The Apparent Widespread Practice Of Prescribing Off-Label Medications For Children With Migraines. However, Little Research Has Been Done To Identify Physician-Prescribing Patterns Of Migraine Medication For Children...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28230453/letter-draft-fda-guidance-considerations-in-demonstrating-interchangeability-with-a-reference-product-overview-and-presentation-related-concerns
#4
Elan Rubinstein
Rubinstein provides consulting services to the pharmaceutical industry, health plans, employers, and specialty pharmacies, and is a member of the editorial advisory board of Specialty Pharmacy News. He was a participant on the Amgen Biosimilar Report Advisory Board and reports consulting fees from Amgen.
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28229907/expression-and-functional-evaluation-of-biopharmaceuticals-made-in-plant-chloroplasts
#5
REVIEW
Bei Zhang, Balamurugan Shanmugaraj, Henry Daniell
After approval of the first plant-made biopharmaceutical by FDA for human use, many protein drugs are now in clinical development. Within the last decade, significant advances have been made in expression of heterologous complex/large proteins in chloroplasts of edible plants using codon optimized human or viral genes. Furthermore, advances in quantification enable determination of in-planta drug dosage. Oral delivery of plastid-made biopharmaceuticals (PMB) is affordable because it eliminates prohibitively expensive fermentation, purification processes addressing major challenges of short shelf-life after cold storage...
February 21, 2017: Current Opinion in Chemical Biology
https://www.readbyqxmd.com/read/28229423/patient-derived-and-intraoperatively-formed-biomaterial-for-tissue-engineering
#6
Shalmli U Joshi, Rares O Barbu, Melissa Carr-Reynolds, Brian Barnes, Syam P Nukavarapu
In this chapter, we introduce a completely intraoperative procedure for obtaining a patient-derived biomaterial in cell therapy and tissue engineering applications. An automated device for processing human peripheral-blood ensures a reproducible method for retrieving the patient's cellular-rich as well as cellular-poor plasma. By substituting calcium for animal-derived thrombin, we engineer a completely autologous hydrogel that eliminates the risk of disease transmission and lowers FDA regulation hurdles. Through this chapter, we will discuss a bedside protocol developed to prepare a patient-derived hydrogel...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28229396/statistical-approaches-to-longitudinal-data-analysis-in-neurodegenerative-diseases-huntington-s-disease-as-a-model
#7
REVIEW
Tanya P Garcia, Karen Marder
Understanding the overall progression of neurodegenerative diseases is critical to the timing of therapeutic interventions and design of effective clinical trials. Disease progression can be assessed with longitudinal study designs in which outcomes are measured repeatedly over time and are assessed with respect to risk factors, either measured repeatedly or at baseline. Longitudinal data allows researchers to assess temporal disease aspects, but the analysis is complicated by complex correlation structures, irregularly spaced visits, missing data, and mixtures of time-varying and static covariate effects...
February 2017: Current Neurology and Neuroscience Reports
https://www.readbyqxmd.com/read/28228973/duchenne-regulatory-science-consortium-meeting-on-disease-progression-modeling-for-duchenne-muscular-dystrophy
#8
Jane Larkindale, Richard Abresch, Enrique Aviles, Abby Bronson, Janice Chin, Pat Furlong, Heather Gordish-Dressman, Elizabeth Habeeb-Louks, Erik Henricson, Hans Kroger, Charles Lynn, Stephen Lynn, Dana Martin, Glen Nuckolls, William Rooney, Klaus Romero, Lee Sweeney, Krista Vandenborne, Glenn Walter, Jodi Wolff, Brenda Wong, Craig M McDonald, Members Of The Duchenne Regulatory Science Consortium Imaging-Dmd Consortium And The Cinrg Investigators
The Duchenne Regulatory Science Consortium (D-RSC) was established to develop tools to accelerate drug development for DMD.  The resulting tools are anticipated to meet validity requirements outlined by qualification/endorsement pathways at both the U.S. Food and Drug Administration (FDA) and European Medicines Administration (EMA), and will be made available to the drug development community. The initial goals of the consortium include the development of a disease progression model, with the goal of creating a model that would be used to forecast changes in clinically meaningful endpoints, which would inform clinical trial protocol development and data analysis...
January 12, 2017: PLoS Currents
https://www.readbyqxmd.com/read/28228288/fda-ce-mark-or-something-else-thinking-fast-and-slow
#9
EDITORIAL
Sundeep Mishra
There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing...
January 2017: Indian Heart Journal
https://www.readbyqxmd.com/read/28227899/peripheral-sensory-stimulation-is-neuroprotective-in-a-rat-photothrombotic-ischemic-stroke-model
#10
Aishwarya Bandla, Chua Le Teng Sherry, Frances Lim, Chan Kim Chuan, Lun-De Liao, Nitish V Thakor, Aishwarya Bandla, Chua Le Teng Sherry, Frances Lim, Chan Kim Chuan, Lun-De Liao, Nitish V Thakor, Lun-De Liao, Nitish V Thakor, Frances Lim, Chua Le Teng Sherry, Aishwarya Bandla, Chan Kim Chuan
Ischemic stroke is one of the leading causes of death and disability in the world. Thrombolytic therapy using recombinant tissue plasminogen activator (rtPA), the only FDA-approved drug for acute ischemia, is limited by a narrow therapeutic time window and risk of hemorrhage. There is a serious need for a neuroprotective therapy which is clinically viable. We earlier demonstrated that peripheral sensory stimulation (PSS) is a potential therapeutic intervention for hyperacute ischemia resulting in recovery of neurovascular functions when administered immediately following ischemia onset in a rat model...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28227862/effects-of-high-frequency-rtms-on-sleep-deprivation-a-pilot-study
#11
D P Martinez-Cancino, J Azpiroz-Leehan, L Jimenez-Angeles, A Garcia-Quintanar, R Santana-Miranda, D P Martinez-Cancino, J Azpiroz-Leehan, L Jimenez-Angeles, A Garcia-Quintanar, R Santana-Miranda, A Garcia-Quintanar, L Jimenez-Angeles, R Santana-Miranda, J Azpiroz-Leehan, D P Martinez-Cancino
Transcranial magnetic stimulation is a neurostimulation technique which has the potential to serve as a unique research tool for investigating a wide variety of fields in cognitive neuroscience. TMS has been approved by the FDA to serve as a treatment to depression and has also been used to evaluate its effects among several conditions such as Alzheimer, Parkinson disease, chronic pain and stroke. High frequency TMS has been previously used with the intention to measure and modulate the negative effects of sleep deprivation in cognitive performance, but there is no consensus about the ideal protocol yet...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28227675/investigating-an-alternative-ring-design-of-transducer-arrays-for-tumor-treating-fields-ttfields
#12
Mario Macedo, Cornelia Wenger, Ricardo Salvador, Sofia R Fernandes, Pedro C Miranda, Mario Macedo, Cornelia Wenger, Ricardo Salvador, Sofia R Fernandes, Pedro C Miranda, Sofia R Fernandes, Pedro C Miranda, Cornelia Wenger, Ricardo Salvador, Mario Macedo
Tumor treating fields (TTFields) is a therapy that inhibits cell proliferation and has been approved by the U.S Food and Drug Administration (FDA) for the treatment of Glioblastoma Multiforme. This anti-mitotic technique works non-invasively and regionally, and is associated with less toxicity and a better quality of life. Currently a device called Optune™ is clinically used which works with two perpendicular and alternating array pairs each consisting of 3×3 transducers. The aim of this study is to investigate a theoretical alternative array design which consists of two rings of 16 transducers and thus permits various field directions...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28227025/arguing-effectiveness-of-biomedical-signal-acquisition-devices-using-colored-petri-nets-models-and-assurance-cases-in-gsn-an-ecg-case-study
#13
Alvaro Sobrinho, Paulo Cunha, Leandro Dias da Silva, Angelo Perkusich, Thiago Cordeiro, Jarbas Segundo, Alvaro Sobrinho, Paulo Cunha, Leandro Dias da Silva, Angelo Perkusich, Thiago Cordeiro, Jarbas Segundo, Leandro Dias da Silva, Paulo Cunha, Alvaro Sobrinho, Angelo Perkusich, Jarbas Segundo, Thiago Cordeiro
Reported cases of adverse events and product recalls expose limitations of biomedical signal acquisition devices. Approximately, ninety percent of the 1.210 recalls reported by the US Food and Drug Administration (FDA) between 2006 and 2011 were of class 2 devices such as Electrocardiography (ECG) devices. We show in this paper how manufacturers of biomedical signal acquisition devices can argue effectiveness of these devices using Colored Petri Nets (CPN) models and assurance cases in Goal Structuring Notation (GSN) by means of an ECG case study...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28226993/first-steps-to-creating-a-platform-for-high-throughput-simulation-of-ttfields
#14
Hadas Sara Hershkovich, Zeev Bomzon, Cornelia Wenger, Noa Urman, Aafia Chaudhry, Dario Garcia-Carracedo, Eilon D Kirson, Uri Weinberg, Yoram Wassermann, Yoram Palti, Hadas Sara Hershkovich, Zeev Bomzon, Cornelia Wenger, Noa Urman, Aafia Chaudhry, Dario Garcia-Carracedo, Eilon D Kirson, Uri Weinberg, Yoram Wassermann, Yoram Palti, Yoram Wassermann, Cornelia Wenger, Uri Weinberg, Hadas Sara Hershkovich, Zeev Bomzon, Eilon D Kirson, Dario Garcia-Carracedo, Yoram Palti, Noa Urman, Aafia Chaudhry
Tumor Treating Fields (TTFields) are low intensity alternating electric fields in the 100-500 KHz frequency range that are known to have an anti-mitotic effect on cancerous cells. In the USA, TTFields are approved by the Food and Drug Administration (FDA) for the treatment of glioblastoma (GBM) in both the newly diagnosed and recurrent settings. Optimizing treatment with TTFields requires a deep understanding of how TTFields distribute within the brain. To address this issue, simulations using realistic head models have been performed...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28226860/an-implantable-designed-for-human-use-peripheral-nerve-stimulation-and-recording-system-for-advanced-prosthetics
#15
John R Lachapelle, Caroline K Bjune, Alexander L Kindle, Andrew Czarnecki, John R Burns, Julianne E Grainger, Carlos A Segura, Brian D Nugent, Tirunelveli S Sriram, Philip D Parks, Edward Keefer, Jonathan Cheng, John R Lachapelle, Caroline K Bjune, Alexander L Kindle, Andrew Czarnecki, John R Burns, Julianne E Grainger, Carlos A Segura, Brian D Nugent, Tirunelveli S Sriram, Philip D Parks, Edward Keefer, Jonathan Cheng, John R Lachapelle, Edward Keefer, Alexander L Kindle, Julianne E Grainger, John R Burns, Philip D Parks, Jonathan Cheng, Andrew Czarnecki, Brian D Nugent, Carlos A Segura, Tirunelveli S Sriram, Caroline K Bjune
Complex suture prostheses that deliver sensory and position feedback require a more sophisticated integration with the human user. Here a micro-size active implantable system that provides many-degree-of-freedom neural feedback in both sensory stimulation and motor control is shown, as one potential human-use solution in DARPA's HAPTIX program. Various electrical and mechanical challenge and solutions in meeting both sensory /motor performance as well as ISO 14708 FDA-acceptable human use in an aspirin-size active implementation are discussed...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28226774/modeling-non-clinical-and-clinical-drug-tests-in-gaucher-disease
#16
Clyde F Phelix, Allen K Bourdon, Greg Villareal, Richard G LeBaron, Clyde F Phelix, Allen K Bourdon, Greg Villareal, Richard G LeBaron, Richard G LeBaron, Clyde F Phelix, Allen K Bourdon, Greg Villareal
There is need for modeling biological systems to accelerate drug pipelines for treating metabolic diseases. The eliglustat treatment for Gaucher disease is approved by the FDA with a companion genomic test. The Transcriptome-To-Metabolome™ biosimulation technology was used to model, in silico, a standard non-clinical eliglustat test with an in vitro canine kidney cell system over-expressing a human gene; and a clinical test using human fibroblasts from control and Gaucher disease subjects. Protein homology modeling and docking studies were included to gather affinity parameters for the kinetic metabolic model...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28226555/an-ultrasonically-powered-implantable-device-for-targeted-drug-delivery
#17
Jayant Charthad, Spyridon Baltsavias, Devleena Samanta, Ting Chia Chang, Marcus J Weber, Niloufar Hosseini-Nassab, Richard N Zare, Amin Arbabian, Jayant Charthad, Spyridon Baltsavias, Devleena Samanta, Ting Chia Chang, Marcus J Weber, Niloufar Hosseini-Nassab, Richard N Zare, Amin Arbabian, Spyridon Baltsavias, Marcus J Weber, Devleena Samanta, Richard N Zare, Ting Chia Chang, Niloufar Hosseini-Nassab, Jayant Charthad, Amin Arbabian
A wirelessly powered implantable device is proposed for fully programmable and localized drug delivery. The implant is powered using an external ultrasonic transmitter and operates at <; 5% of the FDA diagnostic ultrasound intensity limit. Drug release is achieved through electrical stimulation of drug-loaded polypyrrole nanoparticles. A design methodology for the implant electronics is presented and experimentally demonstrated to be accurate in predicting the concentration of the released drug. To the best of our knowledge, this is the first ultrasonically powered implantable device platform for targeted drug delivery using electroresponsive polymers...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28226376/hyaluronic-acid-fillers-in-soft-tissue-regeneration
#18
Arianna Fallacara, Stefano Manfredini, Elisa Durini, Silvia Vertuani
Over the last years, hyaluronic acid (HA) injectable dermal fillers (DFs) have become the most popular agents for soft tissue contouring and volumizing. HA fillers are characterized by most of the properties that an ideal DF should have, due to HA unique chemical-physical properties, biocompatibility, biodegradability, and versatility. Therefore, HA DFs have revolutionized the filler market with a high number of products, which differ in terms of HA source, cross-linkage (agent and degree), HA concentration, hardness, cohesivity, consistency, inclusion or lack of anesthetic, indication, and longevity of correction...
February 2017: Facial Plastic Surgery: FPS
https://www.readbyqxmd.com/read/28226332/responsible-safe-and-effective-prescription-of-opioids-for-chronic-non-cancer-pain-american-society-of-interventional-pain-physicians-asipp-guidelines
#19
Laxmaiah Manchikanti, Adam M Kaye, Nebojsa Nick Knezevic, Heath McAnally, Konstantin Slavin, Andrea M Trescot, Susan Blank, Vidyasagar Pampati, Salahadin Abdi, Jay S Grider, Alan D Kaye, Kavita N Manchikanti, Harold Cordner, Christopher G Gharibo, Michael E Harned, Sheri L Albers, Sairam Atluri, Steve M Aydin, Sanjay Bakshi, Robert L Barkin, Ramsin M Benyamin, Mark V Boswell, Ricardo M Buenaventura, Aaron K Calodney, David L Cedeno, Sukdeb Datta, Timothy R Deer, Bert Fellows, Vincent Galan, Vahid Grami, Hans Hansen, Standiford Helm Ii, Rafael Justiz, Dhanalakshmi Koyyalagunta, Yogesh Malla, Annu Navani, Kent H Nouri, Ramarao Pasupuleti, Nalini Sehgal, Sanford M Silverman, Thomas T Simopoulos, Vijay Singh, Daneshvari R Solanki, Peter S Staats, Ricardo Vallejo, Bradley W Wargo, Arthur Watanabe, Joshua A Hirsch
BACKGROUND: Opioid use, abuse, and adverse consequences, including death, have escalated at an alarming rate since the 1990s. In an attempt to control opioid abuse, numerous regulations and guidelines for responsible opioid prescribing have been developed by various organizations. However, the US opioid epidemic is continuing and drug dose deaths tripled during 1999 to 2015. Recent data show a continuing increase in deaths due to natural and semisynthetic opioids, a decline in methadone deaths, and an explosive increase in the rates of deaths involving other opioids, specifically heroin and illicit synthetic fentanyl...
February 2017: Pain Physician
https://www.readbyqxmd.com/read/28226266/parallel-artificial-liquid-membrane-extraction-of-new-psychoactive-substances-in-plasma-and-whole-blood
#20
Linda Vårdal, Hilde-Merete Askildsen, Astrid Gjelstad, Elisabeth Leere Øiestad, Hilde Marie Erøy Edvardsen, Stig Pedersen-Bjergaard
Parallel artificial liquid membrane extraction (PALME) was combined with ultra-high performance liquid chromatography-mass spectrometry (UHPLC-MS) and the potential for screening of new psychoactive substances (NPS) was investigated for the first time. PALME was performed in 96-well format comprising a donor plate, a supported liquid membrane (SLM), and an acceptor plate. Uncharged NPS were extracted from plasma or whole blood, across an organic SLM, and into an aqueous acceptor solution, facilitated by a pH gradient...
February 14, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
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