In Search of System ‐Wide Productivity Gains ‐ The Role of Global Collaborations in Preclinical Translation
(Source: Clinical and Translational Science)
Source: Clinical and Translational Science - September 19, 2017 Category: Biomedical Science Authors: Anton E. Ussi, Martin Kort, Nathan P. Coussens, Tero Aittokallio, Marian Hajduch Tags: COMMENTARY Source Type: research

Plasma Catechols After Eating Olives
Abstract Olives contain 3,4‐dihydroxyphenyl compounds (catechols)—especially 3,4‐dihydroxyphenylethanol (DOPET)—that have therapeutic potential as nutraceuticals. Whether olive ingestion affects plasma levels of free (unconjugated) catechols has been unknown. Arm venous blood was sampled before and 15, 30, 45, 60, 120, 180, and 240 min after six healthy volunteers ate 10 Kalamata olives. Catechols were assayed by alumina extraction followed by liquid chromatography with series electrochemical detection. Plasma DOPET increased to 18.5 times baseline at 30 min (area under the curve (AUC) 39.2 ± 9.2 pmol‐min/mL, P ...
Source: Clinical and Translational Science - September 12, 2017 Category: Biomedical Science Authors: David S. Goldstein, Courtney Holmes, Jamie Cherup, Yehonatan Sharabi Tags: ARTICLE Source Type: research

Issue Information
(Source: Clinical and Translational Science)
Source: Clinical and Translational Science - September 11, 2017 Category: Biomedical Science Tags: ISSUE INFORMATION Source Type: research

A Pilot Dose ‐Finding Study of Etanercept in Rheumatoid Arthritis
Abstract A randomized, parallel‐dose study assessed the pharmacokinetics (PK) and pharmacodynamics (PD) of etanercept in 61 patients with rheumatoid arthritis (RA) who received doses from 10 mg once‐weekly to 50 mg twice‐weekly for 4 weeks. Empiric application of a maximal‐effect (Emax) model to pooled steady‐state concentrations (Css) and PD markers provided half‐maximal‐effect concentration estimates of 567, 573, 465, 87, and 159 ng/mL for change from baseline in number of swollen joints, number of painful joints, erythrocyte sedimentation rate, interleukin‐6, and matrix metalloproteinase‐3, respectiv...
Source: Clinical and Translational Science - September 11, 2017 Category: Biomedical Science Authors: Ferdinand C. Breedveld, Heather E. Jones, Kim Peifer, Joan Korth ‐Bradley Tags: ARTICLE Source Type: research

The Translational Science Benefits Model: A New Framework for Assessing the Health and Societal Benefits of Clinical and Translational Sciences
We report the development of the Translational Science Benefits Model (TSBM), a framework designed to support institutional assessment of clinical and translational research outcomes to measure clinical and community health impacts beyond bibliometric measures. The TSBM includes 30 specific and potentially measurable indicators that reflect benefits that accrue from clinical and translational science research such as products, system characteristics, or activities. Development of the TSBM was based on literature review, a modified Delphi method, and in‐house expert panel feedback. Three case studies illustrate the feasib...
Source: Clinical and Translational Science - September 8, 2017 Category: Biomedical Science Authors: Douglas A. Luke, Cathy C. Sarli, Amy M. Suiter, Bobbi J. Carothers, Todd B. Combs, Jae L. Allen, Courtney E. Beers, Bradley A. Evanoff Tags: ARTICLE Source Type: research

Electronic Health Record Phenotypes for Precision Medicine: Perspectives and Caveats from Treatment of Breast Cancer at a Single Institution
This article is protected by copyright. All rights reserved (Source: Clinical and Translational Science)
Source: Clinical and Translational Science - September 1, 2017 Category: Biomedical Science Authors: Matthew K. Breitenstein, Hongfang Liu, Kara N. Maxwell, Jyotishman Pathak, Rui Zhang Tags: ARTICLE Source Type: research

Whole Transcriptome Profiling: An RNA ‐Seq Primer and Implications for Pharmacogenomics Research
This article is protected by copyright. All rights reserved (Source: Clinical and Translational Science)
Source: Clinical and Translational Science - September 1, 2017 Category: Biomedical Science Authors: Ana Caroline Costa S á, Wolfgang Sadee, Julie A. Johnson Tags: TUTORIAL Source Type: research

LY3127760, a Selective Prostaglandin E4 (EP4) Receptor Antagonist, and Celecoxib: A Comparison of Pharmacological Profiles
Safety, tolerability, and pharmacology profiles of LY3127760, an EP4 antagonist, were explored in healthy subjects in a subject/investigator‐blind, parallel‐group, multiple‐ascending dose study. Cohorts consisted of 13 patients randomized to LY3127760, celecoxib (400 mg), or placebo (9:2:2 ratio) for 28 days. LY3127760 was well tolerated; the most commonly observed adverse events were gastrointestinal, similar to celecoxib. LY3127760 increased release of ex vivo tumor necrosis factor alpha after lipopolysaccharide/prostaglandin E2 stimulation when compared with placebo, suggesting a dose‐dependent blockade of the E...
Source: Clinical and Translational Science - August 30, 2017 Category: Biomedical Science Authors: Yan Jin, Claire Smith, Leijun Hu, David E. Coutant, Kelly Whitehurst, Krista Phipps, Terry Ann McNearney, Xiao Yang, Bradley Ackermann, Thomas Pottanat, William Landschulz Tags: ARTICLE Source Type: research

Precision Dosing: Public Health Need, Proposed Framework, and Anticipated Impact
Clinical and Translational Science, Page 443-454, March 2018. (Source: Clinical and Translational Science)
Source: Clinical and Translational Science - August 10, 2017 Category: Biomedical Science Source Type: research

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Clinical and Translational Science, Page 443-454, March 2018. (Source: Clinical and Translational Science)
Source: Clinical and Translational Science - August 10, 2017 Category: Biomedical Science Source Type: research

Precision Dosing: Public Health Need, Proposed Framework, and Anticipated Impact
(Source: Clinical and Translational Science)
Source: Clinical and Translational Science - August 10, 2017 Category: Biomedical Science Authors: Daniel Gonzalez, Gauri G. Rao, Stacy C. Bailey, Kim L.R. Brouwer, Yanguang Cao, Daniel J. Crona, Angela D.M. Kashuba, Craig R. Lee, Kathryn Morbitzer, J. Herbert Patterson, Tim Wiltshire, Jon Easter, Scott W. Savage, J. Robert Powell Tags: REVIEW Source Type: research

Single ‐Dose and Multiple‐Dose Pharmacokinetics of Vaniprevir in Healthy Men
Vaniprevir is an inhibitor of the hepatitis C virus (HCV) NS3/4A protease. The aim of these double‐blind, placebo‐controlled phase I studies was to evaluate the safety and pharmacokinetics of vaniprevir in healthy male volunteers. The primary objective for both studies was the safety and tolerability of vaniprevir. Single‐dose and steady‐state pharmacokinetics were also assessed. In both studies, there was no apparent relationship between the frequency or intensity of adverse events and vaniprevir dose. At single doses >20 mg, the plasma area under the curve (AUC)0–∞ and maximum concentration (Cmax) increase...
Source: Clinical and Translational Science - August 10, 2017 Category: Biomedical Science Authors: L Caro, J Hoon, M Depr é, C Cilissen, J Miller, W Gao, D Panebianco, Z Guo, SL Troemel, MS Anderson, N Uemura, J Butterton, J Wagner, DH Wright Tags: ARTICLE Source Type: research

Future of Rare Diseases Research 2017 –2027: an IRDiRC Perspective
This article is protected by copyright. All rights reserved (Source: Clinical and Translational Science)
Source: Clinical and Translational Science - August 10, 2017 Category: Biomedical Science Authors: Christopher P Austin, Christine M Cutillo, Lilian PL Lau, Anneliene H Jonker, Ana Rath, Daria Julkowska, David Thomson, Sharon Terry, Beatrice Montleau, Diego Ardig ò, Virginie Hivert, Kym M Boycott, Gareth Baynam, Petra Kaufmann, Domenica Taruscio, Hann Tags: REVIEW Source Type: research

Oral Apolipoprotein A ‐I Mimetic D‐4F Lowers HDL‐Inflammatory Index in High‐Risk Patients: A First‐in‐Human Multiple‐Dose, Randomized Controlled Trial
In conclusion, oral D‐4F dosing rendered HDL less inflammatory, affirming oral D‐4F as a potential therapy to improve HDL function. (Source: Clinical and Translational Science)
Source: Clinical and Translational Science - August 9, 2017 Category: Biomedical Science Authors: Richard L. Dunbar, Rajesh Movva, LeAnne T. Bloedon, Danielle Duffy, Robert B. Norris, Mohamad Navab, Alan M. Fogelman, Daniel J. Rader Tags: PHASE FORWARD Source Type: research