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https://www.readbyqxmd.com/read/28549348/ocular-toxicities-associated-with-targeted-anticancer-agents-an-analysis-of-clinical-data-with-management-suggestions
#1
Chen Fu, Dan S Gombos, Jared Lee, Goldy C George, Kenneth Hess, Andrew Whyte, David S Hong
Ocular toxicities are among the most common adverse events resulting from targeted anticancer agents and are becoming increasingly relevant in the management of patients on these agents. The purpose of this study is to provide a framework for management of these challenging toxicities based on objective data from FDA labels and from analysis of the literature. All oncologic drugs approved by the FDA up to March 14, 2015, were screened for inclusion. A total of 16 drugs (12 small-molecule drugs and 4 monoclonal antibodies) were analyzed for ocular toxicity profiles based on evidence of ocular toxicity...
May 5, 2017: Oncotarget
https://www.readbyqxmd.com/read/28549280/protocols-for-the-analytical-characterization-of-therapeutic-monoclonal-antibodies-i-non-denaturing-chromatographic-techniques
#2
Alexandre Goyon, Valentina D'Atri, Balazs Bobaly, Elsa Wagner-Rousset, Alain Beck, Szabolcs Fekete, Davy Guillarme
Size-, charge- and hydrophobicity-related variants of a biopharmaceutical product have to be deeply characterized for batch consistency and for the assessment of immunogenicity and safety effects. Size exclusion chromatography (SEC) and ion exchange chromatography (IEX) are considered as the gold standard for the analysis of high molecular weight species (HMWS) and charge-related variants, respectively. Hydrophobic interaction chromatography (HIC) has drawn renewed attention to monitor the small drug payload distribution in the cysteine-linked antibody-drug conjugates (ADC)...
May 11, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/28547273/case-distribution-and-complications-of-mid-urethral-sling-surgery-in-a-canadian-city-before-and-after-the-health-canada-advisory-on-pelvic-floor-mesh
#3
Kevin Carlson, Richard Baverstock, Andrea Civitarese, R Trafford Crump
INTRODUCTION AND HYPOTHESIS: Increased incidences of complications related to the use of mid-urethral slings (MUS) for the treatment of stress urinary incontinence resulted in both the Food and Drug Administration (FDA) and Health Canada issuing advisories in 2008 and 2010 respectively. The purpose of this study was to assess the effect these advisories had on the number of surgeons performing MUS surgery and post-surgical complications in Calgary, Canada. METHODS: In this study, we conducted a retrospective analysis of administrative data between 2006 and 2011...
May 25, 2017: International Urogynecology Journal
https://www.readbyqxmd.com/read/28546372/inhaled-pulmonary-vasodilators-are-there-indications-within-the-pediatric-icu
#4
Bradley A Kuch, Alvin L Saville, Joan Sanchez De Toledo, Shekhar T Venkataraman
Inhaled nitric oxide (INO) is only FDA-cleared for neonates (> 34 weeks gestation) with hypoxic respiratory failure-associated pulmonary hypertension. Off-label use of INO is common in the pediatric population despite a lack of evidence regarding survival benefit, questioning whether the therapy should be considered outside the neonatal period. A lack of definitive evidence combined with increasing health-care costs has led to the use of less costly inhaled prostacyclin as an alternative to INO, presenting unique patient safety concerns...
June 2017: Respiratory Care
https://www.readbyqxmd.com/read/28546306/summaries-of-safety-labeling-changes-approved-by-fda-boxed-warnings-highlights-january-march-2017
#5
(no author information available yet)
No abstract text is available yet for this article.
June 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28546297/summaries-of-safety-labeling-changes-approved-by-fda-boxed-warnings-highlights-january-march-2017
#6
(no author information available yet)
No abstract text is available yet for this article.
June 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28546291/fda-quietly-ends-a-major-risk-management-program
#7
Kate Traynor
No abstract text is available yet for this article.
June 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28546286/three-drugs-approved-for-urothelial-carcinoma-by-fda
#8
(no author information available yet)
The FDA has approved one PD-1 checkpoint inhibitor, pembrolizumab, and two PD-L1 checkpoint inhibitors, avelumab and durvalumab, to treat metastatic urothelial carcinoma in patients whose disease continues to progress despite platinum-based chemotherapy. This brings the total number of checkpoint inhibitors for the disease to five, prompting questions about how best to use them.
May 25, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/28545370/a-systematic-analysis-of-physicochemical-and-adme-properties-of-all-small-molecule-kinase-inhibitors-approved-by-us-fda-from-january-2001-to-october-2015
#9
Zhihong O'Brien, Mehran F Moghaddam
BACKGROUND: During lead identification and optimization, the advancement criteria may be driven based on scientific principles, prior experiences, and/or by examining the path paved by approved drugs. Accessing the discovery data on physicochemical and ADME properties of the approved kinase inhibitors is a monumental task as these are either scattered in the literature or have not been published. OBJECTIVE: Our goals were, 1) to compile the relevant data on all kinase inhibitors approved prior to 2016 for easy access by the biopharmaceutical community, 2) to provide a retrospective analysis to highlight trends and attributes which may have contributed to the "developability" of these drugs, and 3) to ignite focused debates on what constitutes "actionable", "nice-to-have", and unnecessary data...
May 23, 2017: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/28544884/a-validated-uhplc-qtof-ms-method-for-quantification-of-metformin-and-teneligliptin-in-rat-plasma-application-to-pharmacokinetic-interaction-study
#10
David Paul, Lingesh Allakonda, Nanjappan Satheeshkumar
In this study a sensitive UHPLC-QTOF-MS method was developed and validated for the quantitation of the metformin (MET) and teneligliptin (TEN) in rat plasma using dapagliflozin as an internal standard (IS). Chromatographic separation were carried out on a Acquity UPLC HSS Cyano column (100mm x 2.1mm, 1.8μm) using gradient mobile phase system consisting of 0.1% formic acid and acetonitrile at a flow rate of 0.4mL/min, within a run time of 6min. Protein precipitation method was used as sample preparation approach...
May 15, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28544834/in-vitro-pulsatile-flow-measurement-in-prosthetic-heart-valves-an-inter-laboratory-comparison
#11
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
#12
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/28544100/undetectable-concentrations-of-an-fda-approved-high-sensitivity-cardiac-troponin-t-assay-to-rule-out-acute-myocardial-infarction-at-emergency-department-arrival
#13
Andrew D McRae, Grant Innes, Michelle Graham, Eddy Lang, James E Andruchow, Yunqi Ji, Shabnam Vatanpour, Tasnima Abedin, Hong Yang, Danielle A Southern, Dongmei Wang, Isolde Seiden-Long, Lawrence DeKoning, Peter Kavsak
BACKGROUND: The objective of this study was to quantify the sensitivity of very low concentrations of high-sensitivity cardiac troponin T (hsTnT) at ED arrival for acute myocardial infarction (AMI) in a large cohort of chest pain patients evaluated in real-world clinical practice. METHODS: This retrospective study included consecutive ED patients with suspected cardiac chest pain evaluated in four urban EDs were, excluding those with ST-elevation AMI, cardiac arrest or abnormal kidney function...
May 19, 2017: Academic Emergency Medicine: Official Journal of the Society for Academic Emergency Medicine
https://www.readbyqxmd.com/read/28543541/human-schwann-cells-exhibit-long-term-cell-survival-are-not-tumorigenic-and-promote-repair-when-transplanted-into-the-contused-spinal-cord
#14
Johana Bastidas, Gagani Athauda, Gabriela De La Cruz, Wai-Man Chan, Roozbeh Golshani, Yerko Berrocal, Martha Henao, Anil Lalwani, Chikato Mannoji, Mazen Assi, P Anthony Otero, Aisha Khan, Alexander E Marcillo, Michael Norenberg, Allan D Levi, Patrick M Wood, James D Guest, W Dalton Dietrich, Mary Bartlett Bunge, Damien D Pearse
The transplantation of rodent Schwann cells (SCs) provides anatomical and functional restitution in a variety of spinal cord injury (SCI) models, supporting the recent translation of SCs to phase 1 clinical trials for human SCI. Whereas human (Hu)SCs have been examined experimentally in a complete SCI transection paradigm, to date the reported behavior of SCs when transplanted after a clinically relevant contusive SCI has been restricted to the use of rodent SCs. Here, in a xenotransplant, contusive SCI paradigm, the survival, biodistribution, proliferation and tumorgenicity as well as host responses to HuSCs, cultured according to a protocol analogous to that developed for clinical application, were investigated...
May 22, 2017: Glia
https://www.readbyqxmd.com/read/28543367/successful-treatment-of-methicillin-susceptible-staphylococcus-aureus-osteomyelitis-with-oritavancin
#15
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
#16
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
#17
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/28541890/event-triggered-model-predictive-control-for-embedded-artificial-pancreas-systems
#18
Ankush Chakrabarty, Stamatina Zavitsanou, Francis Doyle Iii, Eyal Dassau
OBJECTIVE: The development of artificial pancreas (AP) technology for deployment in low-energy, embedded devices is contingent upon selecting an efficient control algorithm for regulating glucose in people with type 1 diabetes mellitus (T1DM). In this paper, we aim to lower the energy consumption of the AP by reducing controller updates, that is, the number of times the decision-making algorithm is invoked to compute an appropriate insulin dose. METHODS: Physiological insights into glucose management are leveraged to design an event-triggered model predictive controller (MPC) that operates efficiently, without compromising patient safety...
May 23, 2017: IEEE Transactions on Bio-medical Engineering
https://www.readbyqxmd.com/read/28541222/drug-target-prediction-by-multi-view-low-rank-embedding
#19
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
#20
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
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