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. 2005 Feb 3;6(1):1.
doi: 10.1186/1468-6708-6-1.

Methodological considerations in the design of trials for safety assessment of new drugs and chemical entities

Cornel Pater  1
Affiliations

Methodological considerations in the design of trials for safety assessment of new drugs and chemical entities

Cornel Pater. Curr Control Trials Cardiovasc Med. .
No abstract available

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Figures

Figure 1A
Figure 1A
"Humps" on the terminal part of the T-wave reflecting early ADPs. Figure 1b EAD degenerating in tachycardia.
Figure 2A
Figure 2A
12-lead ECG sampling pattern in the run-in period (baseline). Minimum number of recordings are highlighted at 8, 14 and 20 hours. Figure 2B Plasma concentration-time profiles (PK/PD analysis).
Figure 3A
Figure 3A
Plasma concentration-time profile of parent drug. Figure 3B Plasma concentration-time profile of metabolite.
Figure 4
Figure 4
Normal ECG highlighting the common parameters measured when assessing the QT/QTc interval.
Figure 5
Figure 5
Visual Anlogues Scale to assist in reconciliating the inter-observer assessment of TU morphology.
See this image and copyright information in PMC

References

    1. Monahan BP, Ferguson CL, Killeavy ES. Torsade de pointes occurring in association with terfenadine use. JAMA. 1990;264:2788–2790. doi: 10.1001/jama.264.21.2788. - DOI - PubMed
    1. Honig PK, Wortham DC, Zamani K. Terfenadine-ketokonazole interaction: Pharmacokinetic and electrocardiographic consequences. JAMA. 1993;269:1513–1518. doi: 10.1001/jama.269.12.1513. - DOI - PubMed
    1. Echt DS, Liebson PR, Mitchel B. Mortality and morbidity in patients receiving encainide, flecainide, or placebo: the Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1992;324:781–788. - PubMed
    1. Committee for Proprietary Medicinal Products Points to Consider: The Assessment of the Potential for QT Interval Prolongation by Non-Cardiovascular Medicinal Products. The European Agency for Evaluation of Medicinal Products. 1997.
    1. The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. FDA – Draft 4. (June 10, 2004)

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