Introduction: Safety 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.
View Article and Find Full Text PDFJ Pharmacol Toxicol Methods
September 2012
Increasing or decreasing cardiac contractility is an undesirable property of drugs being developed for noncardiovascular indications. The International Conference on Harmonization (ICH) Topic S7A and S7B guidelines only require the assessment of heart rate, blood pressure and the electrocardiogram in nonclinical in vivo safety pharmacology studies. Assessment of drug effects on contractility is only suggested as an optional follow-up study.
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