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Translational Bytes

Translational Bytes


Sep16 Dishing Out the QT Risk

Early identification of QT-prolongation or pro-arrhythmic risk for drugs in development has historically relied on binding or functional assays for hERG and other ion channels, with follow-up studies in animals. This hERG-to-animal approach entails a jump from simple and relatively uncertain to cos...
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Aug21 Moving the Needle for Liquid Biopsy

Historically, cancer detection and drug response monitoring required collecting tumor biopsies, which can be a very invasive procedure, to characterize many types of solid tumors such as non-small cell lung cancer (NSCLC), and is practically infeasible for many others. Furthermore, given their inva...
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Aug09 Learn and Confirm? Or Confirm and Learn the Hard Way?

A  recent publication in  CTS  by Lyauk et al .  presents results from an evaluation of dose selection in NDAs approved by the FDA between 2015 and 2017, in an effort to characterize the extent to which sponsors follow the “learn and confirm” paradigm of dose selection. 
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Jul19 CTS Impact Factor More Than Doubles to 3.989 for the Second Year in a Row!

The most recent impact factor (IF) numbers are in, and  Clinical and Translational Science (CTS)  has again doubled its IF to 3.989. The 2018 IF is the first year that we “own” the entire metric. Last year, we owned half the 2017 metric and the IF was 1.954, while two years ago, the old editori...
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Jul12 The Difference Is Night and Day

Does your study call for recurrent measurement of heart rate or blood pressure? If so, read “ Models of Variability and Circadian Rhythm in Heart Rate, Blood Pressure, and QT Interval for Healthy Subjects Who Received Placebo in Phase I Trials ” by Mukul Minocha  et al . In this creative appr...
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Jun30 Adding to the Transporter DDI Toolbox

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Jun14 Children Are Not Little Adults

There is a saying in experimental pharmacology that preclinical species are not little humans. In clinical pharmacology, the same sentiment is true for pediatric populations. You do not need to be a parent or a pediatrician to realize that children are not just mini versions of adults. Yet a common...
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May20 The ABCs of INDs and CTAs

As part of  CTS ’s continued commitment to providing practical, open access tutorials on tools, methodologies, and approaches in translational medicine, the  CTS  editorial team is delighted to highlight the first in a series of Regulatory Affairs tutorials. The tutorial, “ Regulatory A...
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May10 Brief Is Beautiful

In January 2017  Clinical and Translational Science  launched the  Brief Reports article category . This article type was intended for publication of short-format papers that describe significant novel research findings in translational sciences. During the first four months of 2019 we have seen au...
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Apr24 Celebration of Translation at the ASCPT 2019 Annual Meeting

Congratulations to the  American Society for Clinical Pharmacology and Therapeutics (ASCPT) , Dan Hartman, MD, President, the Scientific Program Committee, chaired by Piet van der Graaf, PhD, PharmD, and all of the speakers, contributors, exhibitors, staff, and attendees for a fantastic 2019 Annu...
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