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https://www.readbyqxmd.com/read/28544834/in-vitro-pulsatile-flow-measurement-in-prosthetic-heart-valves-an-inter-laboratory-comparison
#1
Stephen M Retta, Jeff Kepner, Salvador Marquez, Bruce A Herman, Mark C S Shu, Laurence W Grossman
BACKGROUND AND AIM OF STUDY: One of the first steps in qualifying a new prosthetic valve for eventual clinical use is preclinical flow performance testing in vitro. Such testing is typically performed in an in-vitro test system that simulates the pumping mechanics of the left ventricle of the heart, generally referred to as a pulse duplicator or duplicator. Historically, test results in these systems have varied from duplicator to duplicator. This collaborative effort between heart valve manufacturers and the Food and Drug Administration (FDA) was designed to evaluate the variability of the pulse duplicator test technology for pulsatile flow performance measurement in an interlaboratory round robin...
January 2017: Journal of Heart Valve Disease
https://www.readbyqxmd.com/read/28544443/development-of-a-clinical-trials-version-of-the-impact-of-weight-on-quality-of-life-lite-questionnaire-iwqol-lite-clinical-trials-version-results-from-two-qualitative-studies
#2
R L Kolotkin, C M Ervin, H H Meincke, L Højbjerre, S E Fehnel
Existing measures of health-related quality of life and patient functioning in obesity, such as the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, lack the developmental rigour required by the Food and Drug Administration (FDA) to support product labelling. Two iterative qualitative studies informed development of a version of the IWQOL-Lite questionnaire optimized for use in obesity clinical trials: the IWQOL-Lite Clinical Trials Version. Study 1 included 42 patients with body mass index (BMI) ≥ 30 kg m(-2) (obesity); and Study 2 included 29 patients with type 2 diabetes and BMI ≥ 27 kg m(-2) (overweight)...
May 22, 2017: Clinical Obesity
https://www.readbyqxmd.com/read/28543367/successful-treatment-of-methicillin-susceptible-staphylococcus-aureus-osteomyelitis-with-oritavancin
#3
Dino J Delaportas, Sandy J Estrada, Matthew Darmelio
Staphylococcus aureus remains the most common causative pathogen in osteomyelitis. New or alternate therapies are often needed to adequately treat S. aureus infections in patients with drug allergies, treatment failures, or drug interactions. Oritavancin is a novel long-acting lipoglycopeptide approved by the Food and Drug Administration (FDA) in 2014 for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). With a terminal half-life of 8 to 10 days, oritavancin dosing regimens with infrequent parenteral administration now exist to treat infectious diseases such as osteomyelitis that would otherwise require daily dosing of intravenous antimicrobials for weeks; however clinical experience is lacking...
May 23, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/28542036/a-survey-of-renal-impairment-pharmacokinetic-studies-for-new-oncology-drug-approvals-in-the-usa-from-2010-to-early-2015-a-focus-on-development-strategies-and-future-directions
#4
Jim J Xiao, Jiyun S Chen, Bert L Lum, Richard A Graham
The US Food and Drug Administration (FDA) issued a guidance document in 2010 on pharmacokinetic (PK) studies in renal impairment (RI) on the basis of observations that substances such as uremic toxins might result in altered drug metabolism and excretion. No specific recommendations for oncology drugs were included. We surveyed the publicly available FDA review documents of 29 small molecule oncology drugs approved between 2010 and the first quarter of 2015. The objectives were as follows: (i) summarize the impact of RI on PK at the time of the initial new drug application; (ii) identify limitations of the guidance; and (iii) outline an integrated approach to study the impact of RI on these drugs...
May 24, 2017: Anti-cancer Drugs
https://www.readbyqxmd.com/read/28542026/combination-drug-therapy-of-pioglitazone-and-d-cycloserine-attenuates-chronic-orofacial-neuropathic-pain-and-anxiety-by-improving-mitochondrial-function-following-trigeminal-nerve-injury
#5
Danielle N Lyons, Liping Zhang, Jignesh D Pandya, Robert J Danaher, Fei Ma, Craig S Miller, Patrick G Sullivan, Cristian Sirbu, Karin N Westlund
OBJECTIVES: The study aim was to determine how peripheral trigeminal nerve injury affects mitochondrial respiration and to test efficacy of combined treatment with two FDA approved drugs with potential for improving mitochondrial bioenergetics, pain and anxiety related behaviors in a chronic orofacial neuropathic pain mouse model. METHODS: Efficacy of (R)-(+)-4-amino-3-isoxazolidinone (D-cycloserine, DCS), an NMDA antagonist/agonist, and Pioglitazone (PIO), a selective agonist of nuclear receptor peroxisome proliferator-activated receptor gamma (PPARγ) was investigate in the trigeminal inflammatory compression (TIC) neuropathic nerve injury mouse model...
May 24, 2017: Clinical Journal of Pain
https://www.readbyqxmd.com/read/28541222/drug-target-prediction-by-multi-view-low-rank-embedding
#6
Limin Li, Menglan Cai
Drug repositioning has been a key problem in drug development, and heterogeneous data sources are used to predict drug-target interactions by different approaches. However, most of studies focus on a single representation of drugs or proteins. It has been shown that integrating multi-view representations of drugs and proteins can strengthen the prediction ability. For example, a drug can be represented by its chemical structure, or by its chemical response in different cells. A protein can be represented by its sequence, or by its gene expression values in different cells...
May 18, 2017: IEEE/ACM Transactions on Computational Biology and Bioinformatics
https://www.readbyqxmd.com/read/28540756/nonadjunctive-use-of-continuous-glucose-monitors-for-insulin-dosing
#7
Alan R Shapiro
With the increasing accuracy of continuous glucose monitors (CGM) have come calls for the Food and Drug Administration (FDA) to label these devices as safe for nonadjunctive dosing of insulin. However, there is evidence that these devices are subject to sporadic, unpredictable, large errors. A text analysis of reports to the FDA MAUDE database since 2015 reveals over 25 000 complaints of CGM sensor inaccuracy, with instances directly leading to serious outcomes. These new data were not considered at a recent FDA Advisory Panel meeting that voted to approve Dexcom G5 relabeling for nonadjunctive use...
March 1, 2017: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/28540072/standard-imaging-techniques-in-transcatheter-aortic-valve-replacement
#8
REVIEW
Arash Salemi, Berhane M Worku
Transcatheter aortic valve replacement (TAVR) has become a widely accepted therapeutic option for patients with severe, symptomatic aortic stenosis at intermediate, high, or extreme risk for conventional surgery as determined through a heart team approach. Two valve prostheses are currently available and the Food and Drug Administration (FDA) approved in the United States for TAVR: the self-expandable Medtronic CoreValve (Medtronic, Inc., Minneapolis, MN, USA) and the balloon-expandable Edwards Sapien Valve (Edwards Lifesciences, Irvine CA, USA)...
April 2017: Journal of Thoracic Disease
https://www.readbyqxmd.com/read/28539730/near-infrared-spectroscopy-as-a-process-analytical-technology-tool-for-monitoring-the-parching-process-of-traditional-chinese-medicine-based-on-two-kinds-of-chemical-indicators
#9
Kaiyue Li, Weiying Wang, Yanping Liu, Su Jiang, Guo Huang, Liming Ye
BACKGROUND: The active ingredients and thus pharmacological efficacy of traditional Chinese medicine (TCM) at different degrees of parching process vary greatly. OBJECTIVE: Near-infrared spectroscopy (NIR) was used to develop a new method for rapid online analysis of TCM parching process, using two kinds of chemical indicators (5-(hydroxymethyl) furfural [5-HMF] content and 420 nm absorbance) as reference values which were obviously observed and changed in most TCM parching process...
April 2017: Pharmacognosy Magazine
https://www.readbyqxmd.com/read/28539465/utility-of-genomic-assessment-of-blood-derived-circulating-tumor-dna-ctdna-in-patients-with-advanced-lung-adenocarcinoma
#10
Maria Schwaederle, Sandip P Patel, Hatim Husain, Megumi Ikeda, Richard Lanman, Kimberly C Banks, AmirAli Talasaz, Lyudmila Bazhenova, Razelle Kurzrock
<p>Genomic alterations in blood-derived circulating tumor DNA (ctDNA) from patients with non-small cell lung adenocarcinoma (NSCLC) were ascertained and correlated with clinical characteristics and therapeutic outcomes.</p> <br /><br />Experimental Design: Comprehensive plasma ctDNA testing was performed in 88 consecutive patients; 34 also had tissue next generation sequencing; 29, other forms of genotyping; and 25 (28.4%) had no tissue molecular tests because of inadequate tissue or biopsy contraindications...
May 24, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28539447/a-map-of-the-arenavirus-nucleoprotein-host-protein-interactome-reveals-that-jun%C3%A3-n-virus-selectively-impairs-the-antiviral-activity-of-pkr
#11
Benjamin R King, Dylan Hershkowitz, Philip L Eisenhauer, Marion E Weir, Christopher M Ziegler, Joanne Russo, Emily A Bruce, Bryan A Ballif, Jason Botten
Arenaviruses are enveloped negative-strand RNA viruses that cause significant human disease. Encoding only four proteins to accomplish the viral life cycle, each arenavirus protein likely plays unappreciated accessory roles during infection. Here, we used immunoprecipitation and mass spectrometry to identify human proteins that interact with the nucleoprotein (NP) of the Old World arenavirus lymphocytic choriomeningitis (LCMV) and the New World arenavirus Junín Candid #1 (JUNV). Bioinformatic analysis of the identified protein partners of NP revealed that host translation appears to be a key biological process engaged during infection...
May 24, 2017: Journal of Virology
https://www.readbyqxmd.com/read/28538914/the-regulation-and-adoption-of-health-technologies-under-brazil-s-unified-health-system-barriers-to-access-to-medicines-for-diseases-of-poverty
#12
Rafael Santos Santana, Evandro de Oliveira Lupatini, Silvana Nair Leite
The study aimed to examine the regulation and adoption of health technologies for the diseases of poverty in the Brazil's Unified Health System (SUS). An exploratory, descriptive study was conducted between January and May 2016 consisting of the search and analysis of relevant documents on the websites of Brazil's National Health Surveillance Agency, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the National Commission for the Adoption of Technologies by the SUS, and Saúde Legis (the Ministry of Health's Legislation System)...
May 2017: Ciência & Saúde Coletiva
https://www.readbyqxmd.com/read/28538872/melanoma-tumor-microenvironment-and-new-treatments
#13
Mara Huffenbaecher Giavina-Bianchi, Pedro Francisco Giavina-Bianchi, Cyro Festa
In the recent past years, many discoveries in the tumor microenvironment have led to changes in the management of melanoma and it is rising up hopes, specially, to those in advanced stages. FDA approved seven new drugs from 2011 to 2014. They are: Vemurafenib, Dabrafenib and Trametinib, kinases inhibitors used for patients that have BRAFV600E mutation; Ipilimumab (anti-CTLA4), Pembrolizumab (anti-PD-1) and Nivolumab (anti-PD-1), monoclonal antibodies that stimulate the immune system; and Peginterferon alfa-2b, an anti-proliferative cytokine used as adjuvant therapy...
March 2017: Anais Brasileiros de Dermatologia
https://www.readbyqxmd.com/read/28538203/uhplc-ms-ms-method-with-sample-dilution-to-test-therapeutic-adherence-through-quantification-of-ten-antihypertensive-drugs-in-urine-samples
#14
Amedeo De Nicolò, Valeria Avataneo, Franco Rabbia, Mauro Sciandra, Francesco Tosello, Jessica Cusato, Elisa Perlo, Paolo Mulatero, Franco Veglio, Giovanni Di Perri, Antonio D'Avolio
Nowadays, hypertension represents an important health problem, particularly in developed countries. In some cases the standard therapeutic approaches are not able to reestablish the normal blood pressure values: this condition is called "resistant hypertension". However, a fraction of cases of resistant hypertension are actually due to poor adherence to the prescribed therapy. Therapeutic Drug Monitoring could represent a direct and useful tool to correctly identify non-compliant patients. Nevertheless, high throughput methods for the simultaneous monitoring of a wide panel of drugs in the same analysis are lacking and, furthermore, there is not a generally acknowledged "standard" matrix for this test (plasma or urine)...
May 13, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28538107/local-anesthetics-systemic-toxicity-association-with-exparel-bupivacaine-liposome-a-pharmacovigilance-evaluation
#15
Nitish Aggarwal
BACKGROUND: Local Anesthetic Systemic Toxicity (LAST) is a rare life threatening complication usually from intra-arterial or intravenous injection leading to systemic absorption of regional anesthesia drug. The objective of this research was to statistically quantify the association between Exparel (bupivacaine liposome) injectable suspension and LAST. METHODS: Adverse Event Reporting System database of FDA, which houses public and industry submitted adverse event case reports, was queried and analyzed to quantify the passive pharmacovigilance signal for Local Anesthetic Systemic Toxicity as associated with use of bupivacaine Liposome...
May 24, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28537948/current-techniques-and-outcomes-in-hysteroscopic-sterilization-current-evidence-considerations-and-complications-with-hysteroscopic-sterilization-micro-inserts
#16
James Casey, Laura Cedo-Cintron, Jessica Pearce, Amanda Yunker
PURPOSE OF REVIEW: To describe the current data regarding effectiveness, complications, postoperative evaluation, and surgical interventions associated with Essure hysteroscopic sterilization. RECENT FINDINGS: Hysteroscopic sterilization is a commonly performed procedure that is offered as a well tolerated, effective, outpatient method of permanent sterilization. Over the past several years, concerns have been raised regarding correct placement and postoperative complications...
May 19, 2017: Current Opinion in Obstetrics & Gynecology
https://www.readbyqxmd.com/read/28537061/dolutegravir-lamivudine-as-initial-therapy-in-hiv-1-infected-arv-naive-patients-48-week-results-of-the-paddle-pilot-antiretroviral-design-with-dolutegravir-lamivudine-study
#17
Pedro Cahn, María José Rolón, María Inés Figueroa, Ana Gun, Patricia Patterson, Omar Sued
INTRODUCTION: A proof-of-concept study was designed to evaluate the antiviral efficacy, safety and tolerability of a two-drug regimen with dolutegravir 50 mg once daily (QD) plus lamivudine 300 mg once daily as initial highly active antiretroviral therapy (HAART) among antiretroviral (ARV)-naive patients. METHODS: PADDLE is a pilot study including 20 treatment-naive adults. To be selected, participants had no IAS-USA-defined resistance, HIV-1 RNA ≤100,000 copies/mL at screening and negative HBsAg...
May 9, 2017: Journal of the International AIDS Society
https://www.readbyqxmd.com/read/28536277/3d-mathematical-modeling-of-glioblastoma-suggests-that-transdifferentiated-vascular-endothelial-cells-mediate-resistance-to-current-standard-of-care-therapy
#18
Huaming Yan, Mónica Romero-López, Lesly I Benitez, Kaijun Di, Hermann B Frieboes, Christopher C W Hughes, Daniela A Bota, John S Lowengrub
Glioblastoma (GBM), the most aggressive brain tumor in human patients, is decidedly heterogeneous and highly vascularized. Glioma stem/initiating cells (GSC) are found to play a crucial role by increasing cancer aggressiveness and promoting resistance to therapy. Recently, crosstalk between GSC and vascular endothelial cells has been shown to significantly promote GSC self-renewal and tumor progression. Further, GSC also transdifferentiate into bona-fide vascular endothelial cells (GEC), which inherit mutations present in GSC and are resistant to traditional anti-angiogenic therapies...
May 23, 2017: Cancer Research
https://www.readbyqxmd.com/read/28536155/brigatinib-approved-but-treatment-role-uncertain
#19
(no author information available yet)
The FDA has approved the ALK inhibitor brigatinib for patients with metastatic non-small cell lung cancer who cannot take crizotinib or whose disease worsened despite its use. The decision was based upon results of a phase II study that assessed two drug doses, with overall response rates of 45% and 56% respectively. The drug's effect on overall survival remains unclear, as does the optimal sequence of brigatinib and the three other ALK inhibitors.
May 23, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/28534756/opportunities-for-data-science-in-the-pharmaceutical-industry-the-use-of-data-to-find-efficiencies-in-drug-development-can-t-come-too-soon
#20
Nirmal Keshava
By the numbers, 2016 was not a good year for the U.S. pharmaceutical industry. As of early December, only 19 new drugs had been approved by the Food and Drug Administration (FDA), fewer than half of those approved in 2015 and the lowest number since 2007. Further, the FDA approved only 61% of submissions in 2016, compared to 95% in 2015 [1]. And, among the largest companies, the return on investment for research and development (R&D) fell to 3.7% [2].
May 2017: IEEE Pulse
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