Article ID Journal Published Year Pages File Type
5556601 Journal of Pharmacological and Toxicological Methods 2016 8 Pages PDF
Abstract

IntroductionSafety studies generate a significant volume of waveform and calculated data. The verification of calculated data and the process of searching through these data for patterns of interest (including arrhythmias) is time intensive. Data Insights™ has been developed for the Ponemah™ software platform to provide efficient verification and search capabilities.MethodsSearches may be constructed using calculated and pattern matching data available in Ponemah. Searches are composed of one or more search clauses that may be combined using Boolean operators (AND, OR). Each search clause is a Boolean expression composed of inputs and functions. Data Insights includes a number of predefined species-specific searches for arrhythmias that were qualified for canine, non-human primate and minipigs. Qualification compared arrhythmias identified using Data Insights against a board-certified veterinary cardiologist hand-scored reference datasets.ResultsIn seven out of eight arrhythmia types, arrhythmia incidences identified by Data Insights were congruent to those identified by hand-scoring. Premature Atrial Contractions (PACs) accounted for the only discrepancy in hand scored data-segments, although all overt PACs identified by the veterinary cardiologist were also identified by Data Insights. Unscored atrio-ventricular blocks accounted for the remaining differences.DiscussionData Insights may be used to support different applications, as searches may be created for any physiologic signal type. Its interactive dialog permits rapid review of search results and a dynamic method for handling outliers, signal noise, and false positives. Data Insights provides an efficient method to locate, present, and report on data patterns and anomalies for accurate, consistent results.

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Health Sciences Pharmacology, Toxicology and Pharmaceutical Science Pharmacology
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