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Clinical and Translational Science

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
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
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
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
R N Schuck, R Charlab, G M Blumenthal
No abstract text is available yet for this article.
February 3, 2017: Clinical and Translational Science
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
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
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
Heleen Scheerens, Audrey Malong, Katia Bassett, Zachary Boyd, Vinita Gupta, Jeffrey Harris, Cheryl Mesick, Sarah Simnett, Heather Stevens, Houston Gilbert, Philip Risser, Rasika Kalamegham, Josh Jordan, Julie Engel, Seong Chen, Laurent Essioux, J Andrew Williams
No abstract text is available yet for this article.
January 25, 2017: Clinical and Translational Science
Michael A Pacanowski
Precision medicine is based on a simple precept that deep information about an individual patient can be used to guide his or her health care. In the not-too-distant future, clinicians may have point-of-care access to an individual's entire genome, dense data captured from wearable devices, and informatics tools that aggregate data from clinical experience to allow for real-time decision support. The innovative technologies being developed in pursuit of precision medicine afford researchers and clinicians the opportunity to generate and consume information at an unprecedented scale...
January 20, 2017: Clinical and Translational Science
Matthew M Davis, Thomas P Shanley
In principle, precision medicine incorporates disease prevention and treatment that takes into account individual differences in people's genes, environments, and lifestyles. In practice, research regarding genes attracts more attention and resources than research focused on environments and lifestyles. Such progress-hindering asymmetry may be related to dissimilar naming conventions across scientific domains. We propose a novel "-ome"-based nomenclature that incorporates known social and environmental determinants of human health, and thereby reflects evidence across the full spectrum of scientific endeavors in precision medicine...
January 19, 2017: Clinical and Translational Science
Lisa M McShane
Biomarkers underlie many clinical tests that are integral to the practice of personalized medicine. Reproducibility and scientific credibility of clinical biomarker early development studies are critical to avoid advancing worthless or potentially harmful biomarker-based tests into late phase clinical studies and clinical practice. This commentary discusses key aspects to consider when conducting and evaluating early clinical biomarker research. Greater attention to these aspects would enhance research reproducibility and better prioritize biomarkers for further clinical development...
January 16, 2017: Clinical and Translational Science
John A Wagner
The vision for the 2015-2020 American Society for Clinical Pharmacology and Therapeutics (ASCPT) strategic plan is that ASCPT's influence and leadership make it the authority on the science and practice of translational medicine, building on a foundation of clinical pharmacology and therapeutics []. The vision for Clinical and Translational Science (CTS) is well-suited for ASCPT.(1) Our vision is to become the beacon and organizing principle for the field of translational medicine, as well as to provide a vehicle for ASCPT member publications...
January 16, 2017: Clinical and Translational Science
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
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
Elmar Nimmesgern, Indridi Benediktsson, Irene Norstedt
Personalised medicine is a promising new concept for dealing with challenges of health and health systems. With the launch of the International Consortium of Personalised Medicine, which brings together health research funders and policy making organisations, European countries aim to coordinate research and health policy to advance the implementation of personalised medicine. This article is protected by copyright. All rights reserved.
January 12, 2017: Clinical and Translational Science
Michael J Rappel, Nina L Hunter, April I Alexandrow, Kyle O Hair, Rachel E Sherman, Robert M Califf
Therapeutics known as combination products because they combine drug, device, and/or biologic elements can offer important advantages relative to single-modality products. However, regulatory policy in this arena has lagged relative to increases in product submissions and complexity of these products. In this article, we describe how the US Food and Drug Administration (FDA) applied Lean management methods to improve and streamline the process by which different FDA Centers and Offices coordinate review of combination products...
January 12, 2017: Clinical and Translational Science
Lucie A Low, Danilo A Tagle
No abstract text is available yet for this article.
January 11, 2017: Clinical and Translational Science
J D Backman, L M Yerges-Armstrong, R B Horenstein, S Newcomer, S Shaub, M Morrisey, P Donnelly, M Drolet, K Tanner, M A Pavlovich, J R O'Connell, B D Mitchell, J P Lewis
Genetic variation in the platelet endothelial aggregation receptor 1 (PEAR1) gene, most notably rs12041331, is implicated in altered on-aspirin platelet aggregation and increased cardiovascular event risk. We prospectively tested the effects of aspirin administration at commonly prescribed doses (81, 162, and 324 mg/day) on agonist-induced platelet aggregation by rs12041331 genotype in 67 healthy individuals. Prior to aspirin administration, rs12041331 minor allele carriers had significantly reduced adenosine diphosphate (ADP)-induced platelet aggregation compared with noncarriers (P = 0...
January 11, 2017: Clinical and Translational Science
R A Farris, E T Price
Clinical trials suggest that fenofibrate reduces the progression of retinopathies in patients with type 2 diabetes. Furthermore, patients with retinopathies have elevated levels of inflammatory chemokines and dysfunctional retinal angiogenesis. Therefore, we investigated the effects of fenofibrate on the production of inflammatory chemokines and genes associated with angiogenesis. Retinal pigment epithelial cells (RPECs) were cultured with IL-1β and fenofibrate ranging from 1-50 μM. ENA-78, IL-8, and RANTES were measured in cell culture by ELISA...
December 20, 2016: Clinical and Translational Science
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