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Clinical and Translational Science

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https://www.readbyqxmd.com/read/28297195/clinical-pharmacology-and-translational-aspects-of-bispecific-antibodies
#1
REVIEW
A Trivedi, S Stienen, M Zhu, H Li, T Yuraszeck, J Gibbs, T Heath, R Loberg, S Kasichayanula
No abstract text is available yet for this article.
March 15, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28294551/the-ignite-pharmacogenetics-working-group-an-opportunity-for-building-evidence-with-pharmacogenetic-implementation-in-a-real-world-setting
#2
REVIEW
L H Cavallari, A L Beitelshees, K V Blake, L G Dressler, J D Duarte, A Elsey, J N Eichmeyer, P E Empey, J P Franciosi, J K Hicks, A M Holmes, Ljb Jeng, C R Lee, J J Lima, N A Limdi, J Modlin, A O Obeng, N Petry, V M Pratt, T C Skaar, S Tuteja, D Voora, M Wagner, K W Weitzel, R A Wilke, J F Peterson, J A Johnson
No abstract text is available yet for this article.
March 14, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28271602/early-vision-for-the-ctsa-program-trial-innovation-network-a-perspective-from-the-national-center-for-advancing-translational-sciences-ncats
#3
Monica R Shah, Michelle A Culp, Kenneth R Gersing, Patricia L Jones, Mary E Purucker, Tiina Urv, Todd M Wilson, Petra Kaufmann
The Trial Innovation Network, an initiative of the Clinical and Translational Science Award (CTSA) Program, is a national, multi-disciplinary platform that will enable multi-center clinical trials and studies. A key goal of the Trial Innovation Network is to increase the efficiency and effectiveness of clinical trials and studies by focusing on innovation, excellence, and collaboration, leveraging the strength and expertise of the CTSA Program, and fostering partnerships among NIH, researchers, participants, providers, industry, and other stakeholders...
March 8, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28238224/a-comparative-toxidrome-analysis-of-human-organophosphate-and-nerve-agent-poisonings-using-social-media
#4
D S Reddy, E Colman
Here we utilized social media to compare the toxidrome of three lethal chemical exposures worldwide. YouTube videos were the main source from which the data were collected, but published reports and news were also utilized to fill in some gaps. All videos were organized in a database detailing symptoms and severity of each victim, along with demographics such as approximate age and gender. Each symptom was rated as mild, moderate, or severe and corresponding pie graphs for each incident were compared. The videos displayed symptoms ranging from mild to severe cholinergic toxicity and life-threatening convulsions...
February 26, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28233944/therapeutic-differences-in-24-h-ambulatory-blood-pressures-in-patients-switched-between-bioequivalent-nifedipine-osmotic-systems-with-differing-delivery-technologies
#5
P T Pollak, R J Herman, R D Feldman
Comparing modified-release formulations can be difficult using current bioequivalence criteria. Two 60-mg-once-daily nifedipine formulations are deemed bioequivalent in Canada. This study examined the validity of the assumption that these interchangeable, but different, delivery technologies are therapeutically equivalent in maintaining systolic blood pressure (SBP) control throughout the entire dosing interval. We used 24-h Ambulatory Blood Pressure Monitoring to objectively examine whether formulation switches changed population SBP >2 mmHg (reflecting 6% increased stroke mortality) and in what proportion of patients SBP changed ≥6 mmHg (risking unnecessary therapeutic alterations)...
February 24, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28213901/high-throughput-assays-to-assess-the-functional-impact-of-genetic-variants-a-road-towards-genomic-driven-medicine
#6
J Ipe, M Swart, K S Burgess, T C Skaar
No abstract text is available yet for this article.
February 18, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28198590/effect-of-therapeutic-and-supratherapeutic-doses-of-vonoprazan-on-the-qt-qtc-interval-in-a-phase-i-randomized-study-in-healthy-subjects
#7
B Astruc, H Jenkins, R Jenkins
This phase I, randomized, 4-period, 4-sequence, double-blind, active- and placebo-controlled, crossover study assessed the effects of vonoprazan on the QT/QTc interval in healthy subjects. Subjects received single oral doses of vonoprazan 40 mg, vonoprazan 120 mg, moxifloxacin 400 mg (positive control/open label), and placebo. The primary end point was time-matched, placebo-corrected, baseline-adjusted mean Fridericia-corrected QT interval (ddQTcF). Of 64 subjects (mean age, 37.8 years; 50% male), 63 received all four regimens...
February 15, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28181420/hypoxia-inducible-factor-1-a-urinary-biomarker-of-kidney-disease
#8
S Movafagh, D Raj, M Sanaei-Ardekani, D Bhatia, K Vo, M Mahmoudieh, R Rahman, E H Kim, A F Harralson
Identifying noninvasive biomarkers of kidney disease is valuable for diagnostic and therapeutic purposes. Hypoxia inducible factor 1 (HIF-1) expression is known to be elevated in the kidneys in several renal disease pathologies. We hypothesized that the urinary HIF-1a mRNA level may be a suitable biomarker for expression of this protein in chronic kidney disease (CKD). We compared HIF-1a mRNA levels from urine pellets of CKD and healthy subjects. To ensure that urinary HIF-1a mRNA is of kidney origin, we examined colocalization of HIF-1a mRNA with two kidney specific markers in urine cells...
February 9, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28160443/leveraging-genomic-factors-to-improve-benefit-risk
#9
R N Schuck, R Charlab, G M Blumenthal
No abstract text is available yet for this article.
February 3, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28160433/importance-of-drug-pharmacokinetics-at-the-site-of-action
#10
REVIEW
M L Rizk, L Zou, R M Savic, K E Dooley
No abstract text is available yet for this article.
February 3, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28160427/performance-of-redox-active-and-chelatable-iron-assays-to-determine-labile-iron-release-from-intravenous-iron-formulations
#11
A B Pai, D E Meyer, B C Bales, V E Cotero, M P Pai, N Zheng, W Jiang
Emerging data from global markets outside the United States, where many generic iron sucrose formulations are available, have revealed that non-US generic intravenous (i.v.) iron formulations may have iron release profiles that differ from the reference listed drug (RLD). The first generic i.v. iron approved in the United States was sodium ferric gluconate complex in 2011. We evaluated chelatable and redox labile iron assay methods to measure the amount of labile iron released from i.v. iron formulations in biorelevant matrices in vitro...
February 3, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28146309/giving-up-on-precision-oncology-not-so-fast
#12
REVIEW
Jeremy L Warner
The vision of matching the right patient to the right treatment at the right time has always been the holy grail of oncology. Until recently, very few cancer patients enjoyed the benefits of truly "personalized" a.k.a. precision therapy. With the exploding knowledge of tumor genotype, as well as increasingly available targeted treatment options, it seems that the era of precision cancer medicine is nigh. However, as with many new paradigms, there has been substantial pushback. This article is protected by copyright...
February 1, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28121072/current-status-of-companion-and-complementary-diagnostics-strategic-considerations-for-development-and-launch
#13
H Scheerens, A Malong, K Bassett, Z Boyd, V Gupta, J Harris, C Mesick, S Simnett, H Stevens, H Gilbert, P Risser, R Kalamegham, J Jordan, J Engel, S Chen, L Essioux, J A Williams
US Food and Drug Administration (FDA)-approved diagnostic assays play an increasingly common role in managing patients to prolong lifespan while also enhancing quality of life. Diagnostic assays can be essential for the safe and effective use of therapeutics (companion diagnostic), or may inform on improving the benefit/risk ratio without restricting drug access (complementary diagnostic). This tutorial reviews strategic considerations for drug and assay development resulting in FDA-approved companion or complementary diagnostic status...
January 25, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28106333/translating-precision
#14
EDITORIAL
M A Pacanowski
No abstract text is available yet for this article.
January 20, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28105795/the-missing-omes-proposing-social-and-environmental-nomenclature-in-precision-medicine
#15
M M Davis, T P Shanley
No abstract text is available yet for this article.
January 19, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28093878/in-pursuit-of-greater-reproducibility-and-credibility-of-early-clinical-biomarker-research
#16
L M McShane
No abstract text is available yet for this article.
January 16, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28093866/advancing-clinical-and-translational-science
#17
EDITORIAL
J A Wagner
No abstract text is available yet for this article.
January 16, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28088839/pharmacokinetic-pharmacodynamic-modeling-of-the-pde4-inhibitor-tak-648-in-type-2-diabetes-early-translational-approaches-for-human-dose-prediction
#18
N Plock, S Vollert, M Mayer, G Hanauer, G Lahu
TAK-648 is a PDE4 inhibitor with demonstrated preclinical antidiabetic properties. Our objective was to develop a translational pharmacokinetic/pharmacodynamic (PK/PD) model for human type 2 diabetes (T2D) dose prediction using HbA1c results from a db/db mouse study. Estimated parameters in combination with tPDE4i values calculated for the clinical roflumilast dose of 500 μg were used to translate preclinical effects of TAK-648 to required exposure in humans. A first-in-human study with single TAK-648 doses of 0...
January 15, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28083989/final-nih-policy-on-the-use-of-a-single-institutional-review-board-for-multi-site-research
#19
Valery M Gordon, Michelle A Culp, Carrie D Wolinetz
For nearly 50 years, the Common Rule has required Institutional Review Board (IRB) oversight of federally-funded research to protect the rights and welfare of human research participants. Over time, research has changed and research studies often involve multiple sites. Recognizing that research policies must evolve with science and ensure both efficiency and protections for research participants, NIH released a Policy on the Use of a Single Institutional Review Board for Multi-Site Research in June 2016. This article is protected by copyright...
January 13, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28083940/personalized-medicine-in-europe
#20
E Nimmesgern, I Benediktsson, I Norstedt
No abstract text is available yet for this article.
January 12, 2017: Clinical and Translational Science
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