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https://www.readbyqxmd.com/read/28230456/off-label-prescribing-for-children-with-migraines-in-u-s-ambulatory-care-settings
#1
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/28229907/expression-and-functional-evaluation-of-biopharmaceuticals-made-in-plant-chloroplasts
#2
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/28228973/duchenne-regulatory-science-consortium-meeting-on-disease-progression-modeling-for-duchenne-muscular-dystrophy
#3
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/28227899/peripheral-sensory-stimulation-is-neuroprotective-in-a-rat-photothrombotic-ischemic-stroke-model
#4
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/28227675/investigating-an-alternative-ring-design-of-transducer-arrays-for-tumor-treating-fields-ttfields
#5
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
#6
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
#7
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/28226774/modeling-non-clinical-and-clinical-drug-tests-in-gaucher-disease
#8
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
#9
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
#10
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
#11
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/28224371/can-disproportionality-analysis-of-post-marketing-case-reports-be-used-for-comparison-of-drug-safety-profiles
#12
Christiane Michel, Emil Scosyrev, Michael Petrin, Robert Schmouder
Clinical trials usually do not have the power to detect rare adverse drug reactions. Spontaneous adverse reaction reports as for example available in post-marketing safety databases such as the FDA Adverse Event Reporting System (FAERS) are therefore a valuable source of information to detect new safety signals early. To screen such large data-volumes for safety signals, data-mining algorithms based on the concept of disproportionality have been developed. Because disproportionality analysis is based on spontaneous reports submitted for a large number of drugs and adverse event types, one might consider using these data to compare safety profiles across drugs...
February 21, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28224235/oral-mucosal-changes-induced-by-anticancer-targeted-therapies-and-immune-checkpoint-inhibitors
#13
REVIEW
Emmanuelle Vigarios, Joel B Epstein, Vincent Sibaud
Development of biological targeted therapies and immune checkpoint inhibitors has redefined the treatment for many cancers; however, the increasing use of new protocols has led to physicians observing a new spectrum of toxicities. To date, oral adverse events induced by these new anticancer therapies have been mainly reported using nonspecific terminology ("stomatitis," "mucosal inflammation," "mucositis") and remain poorly characterized, with the exception of mammalian target of rapamycin (mTOR) inhibitor-associated stomatitis...
February 22, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28222460/elements-for-success-in-managing-type-2-diabetes-with-sglt-2-inhibitors-overview-of-the-efficacy-and-safety-of-sglt-2-inhibitors-in-type-2-diabetes-mellitus
#14
Eden M Miller
Since the approval of the first sodium-glucose cotransporter-2 (SGLT-2) inhibitor by the US Food and Drug Administration (FDA) in 2013, the SGLT-2 inhibitors have assumed key roles in the management of patients with type 2 diabetes mellitus (T2DM). This review covers the safety and efficacy of these agents when used in this patient population.
February 2017: Journal of Family Practice
https://www.readbyqxmd.com/read/28222220/meaningful-endpoints-for-therapies-approved-for-hematologic-malignancies
#15
B Douglas Smith, Amy E DeZern, Alex W Bastian, Brian G M Durie
BACKGROUND: Overall survival (OS) is considered the gold standard for determining treatment efficacy in oncology trials, but the relation between treatment and OS can be challenging to assess because of long study durations and the impact of subsequent therapies on outcome. Using OS can be particularly difficult for new therapies in hematologic malignancies (HMs). METHODS: This retrospective analysis was conducted to characterize the primary endpoints used to support US Food and Drug Administration (FDA) approvals for new drug or novel HM indications between January 2002 and July 2015...
February 21, 2017: Cancer
https://www.readbyqxmd.com/read/28221926/evaluation-of-selected-nutrients-and-contaminants-in-distillers-grains-from-ethanol-production-in-texas
#16
Kyung-Min Lee, Timothy J Herrman, Lynn Post
This article contains the results of the evaluation of distillers grain (DG) coproducts from different ethanol plants around the United States and supplemented in animal diets in Texas, based on samples analyzed from 2008 to 2014. The samples were assessed for concentration, occurrence, and prevalence of selected nutrients and contaminants. Protein and sulfur contents of DG were largely different between maize and sorghum coproducts, as well as wet distillers grain with solubles (WDGS) and dried distillers grain with solubles (DDGS), indicating a significant effect of grain feedstock and dry grind process stream on DG composition and quality...
September 2016: Journal of Food Protection
https://www.readbyqxmd.com/read/28221923/matrix-specific-method-validation-of-an-automated-most-probable-number-system-for-use-in-measuring-bacteriological-quality-of-grade-a-milk-products
#17
Samantha Lindemann, Matthew Kmet, Ravinder Reddy, Steffen Uhlig
The U.S. Food and Drug Administration (FDA) oversees a long-standing cooperative federal and state milk sanitation program that uses the grade "A" Pasteurized Milk Ordinance standards to maintain the safety of grade "A" milk sold in the United States. The Pasteurized Milk Ordinance requires that grade "A" milk samples be tested using validated total aerobic bacterial and coliform count methods. The objective of this project was to conduct an interlaboratory method validation study to compare performance of a film plate method with an automated most-probable-number method for total aerobic bacterial and coliform counts, using statistical approaches from international data standards...
November 2016: Journal of Food Protection
https://www.readbyqxmd.com/read/28221064/breaking-ground-for-psychological-science-the-u-s-food-and-drug-administration
#18
Baruch Fischhoff
The U.S. Food and Drug Administration (FDA) regulates products accounting for 20% of U.S. consumer spending. Many of its actions depend on assumptions about behavior. Will people heed food recall notices? Will they follow medication schedules? Will they have realistic expectations regarding the benefits and risks of new products? Over time, FDA has increasingly made psychology integral to its processes for answering such questions. That progress has come when windows of opportunity have found psychologists with science relevant to FDA's needs, FDA with staff who can translate that research into agency terms, and a regulatory arena that can accommodate behavioral evidence...
February 2017: American Psychologist
https://www.readbyqxmd.com/read/28220519/red-blood-cell-concentrates-treated-with-the-amustaline-s-303-pathogen-reduction-system-and-stored-for-35-days-retain-post-transfusion-viability-results-of-a-two-centre-study
#19
J A Cancelas, J L Gottschall, N Rugg, S Graminske, M A Schott, A North, N Huang, N Mufti, A Erickson, S Rico, L Corash
BACKGROUND AND OBJECTIVES: Pathogen reduction technology using amustaline (S-303) was developed to reduce the risk of transfusion-transmitted infection and adverse effects of residual leucocytes. In this study, the viability of red blood cells (RBCs) prepared with a second-generation process and stored for 35 days was evaluated in two different blood centres. MATERIALS AND METHODS: In a single-blind, randomized, controlled, two-period crossover study (n = 42 healthy subjects), amustaline-treated (Test) or Control RBCs were prepared in random sequence and stored for 35 days...
February 21, 2017: Vox Sanguinis
https://www.readbyqxmd.com/read/28219976/the-effects-of-tobacco-control-policies-on-retailer-sales-to-minors-in-the-usa-2015
#20
Hongying Dai, Jianqiang Hao
BACKGROUND: Under the 2009 Family Smoking Prevention and Tobacco Control Act , the Food and Drug Administration (FDA) has been routinely inspecting tobacco retailers' compliance with under-age sales laws. We seek to identify factors associated with Retail Violation Rate for sale to minors (RVRm). METHODS: We collected the tobacco retailer inspection data for 2015 from the FDA compliance check database. RVRm was calculated at the census tract level and overlaid with tobacco regulations and youth smoking prevalence at the state level...
February 20, 2017: Tobacco Control
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