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Evaluating cardiac risk: exposure response analysis in early clinical drug development

Overview of attention for article published in Drug, Healthcare and Patient Safety, April 2018
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Title
Evaluating cardiac risk: exposure response analysis in early clinical drug development
Published in
Drug, Healthcare and Patient Safety, April 2018
DOI 10.2147/dhps.s133286
Pubmed ID
Authors

Julie Grenier, Sabina Paglialunga, Bruce H Morimoto, Robert M Lester

Abstract

The assessment of a drug's cardiac liability has undergone considerable metamorphosis by regulators since International Council for Harmonization of Technical Requirement for Pharmaceuticals for Human Use E14 guideline was introduced in 2005. Drug developers now have a choice in how proarrhythmia risk can be evaluated; the options include a dedicated thorough QT (TQT) study or exposure response (ER) modeling of intensive electrocardiogram (ECG) captured in early clinical development. The alternative approach of ER modeling was incorporated into a guidance document in 2015 as a primary analysis tool which could be utilized in early phase dose escalation studies as an option to perform a dedicated TQT trial. This review will describe the current state of ER modeling of intensive ECG data collected during early clinical drug development; the requirements with regard to the use of a positive control; and address the challenges and opportunities of this alternative approach to assessing QT liability.

X Demographics

X Demographics

The data shown below were collected from the profiles of 3 X users who shared this research output. Click here to find out more about how the information was compiled.
Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 12 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 12 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 7 58%
Student > Ph. D. Student 2 17%
Other 1 8%
Unknown 2 17%
Readers by discipline Count As %
Pharmacology, Toxicology and Pharmaceutical Science 6 50%
Agricultural and Biological Sciences 2 17%
Medicine and Dentistry 2 17%
Unknown 2 17%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 3. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 23 August 2019.
All research outputs
#15,048,620
of 25,584,565 outputs
Outputs from Drug, Healthcare and Patient Safety
#91
of 156 outputs
Outputs of similar age
#177,858
of 344,304 outputs
Outputs of similar age from Drug, Healthcare and Patient Safety
#2
of 4 outputs
Altmetric has tracked 25,584,565 research outputs across all sources so far. This one is in the 40th percentile – i.e., 40% of other outputs scored the same or lower than it.
So far Altmetric has tracked 156 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 11.8. This one is in the 40th percentile – i.e., 40% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 344,304 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 47th percentile – i.e., 47% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 4 others from the same source and published within six weeks on either side of this one. This one has scored higher than 2 of them.