Validation testing of the SEER real-time digital holter monitor

London, Martin J.

doi:10.1016/s1053-0770(05)80011-4

Cited by 2 publications

(1 citation statement)

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“…These were obtained on the baseline day −1 before dosing, on the dosing day 1, and on the subsequent day 2. The recordings were made using 12‐lead ECG monitors (SEER MC recorder, GE Healthcare, Milwaukee, Wis) programmed to obtain a 10‐second ECG sample every 10 seconds 5 . Following careful skin preparation, new electrodes were used in Mason‐Likar position to obtain each continuous ECG recording.…”

Section: Methodsmentioning

confidence: 99%

Near‐Thorough QT Study as Part of a First‐In‐Man Study

Malik

Hnatkova

Ford

et al. 2008

The Journal of Clinical Pharma

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Detailed electrocardiographic (ECG) support was provided to a first-in-man, single-ascending-dose study that included 6 cohorts of 8 male volunteers each. In each cohort, 6 and 2 subjects received active compound and placebo, respectively. Long-term 12-lead ECGs were obtained on baseline day -1, dosing day 1, and day 2. Automatic QT-interval measurements were made at 63 time points (28 at baseline and 35 on treatment). Based on QT/RR distribution, 20% of measurements were visually verified. Baseline-corrected time-matched DeltaQTc values were obtained at 35 postdose time points. Placebo subjects of all cohorts were pooled. When 2 cohorts of the lowest, middle, and highest doses were pooled (12 subjects per active treatment group), the spreads of placebo-corrected DeltaDeltaQTc values were within the regulatory requirements (single-sided 95% confidence interval <10 milliseconds) at all time points. Thus, this ECG support of the first-in-man study provided data of regulatory acceptable accuracy at a small fraction of the cost of a full thorough QT study.

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Section: Methodsmentioning

confidence: 99%