Concentration-effect modeling based on change from baseline to assess the prolonging effect of drugs on QTc together with an estimate of the circadian time course-Reference-Cited by-同舟云学术

Concentration-effect modeling based on change from baseline to assess the prolonging effect of drugs on QTc together with an estimate of the circadian time course

Published:2014-06-27 Issue:12 Volume:54 Page:1400-1406
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Ferber Georg¹,Wang Duolao²,Täubel Jörg³

Affiliation:

1. Statistik Georg Ferber GmbH; Cagliostrostrasse 14; Riehen Switzerland

2. Biostatistics Unit; Liverpool School of Tropical Medicine; Pembroke Place; Liverpool L3 5QA UK

3. Richmond Pharmacology Ltd; St George's University of London; Cranmer Terrace; London UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference12 articles.

1. http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500002879

2. The IQ-CSRC prospective clinical Phase 1 study: “Can early QT assessment using exposure response analysis replace the thorough QT study?”;Darpo;Ann Noninvasive Electrocardiol,2014

3. Statistical issues including design and sample size calculation in thorough QT/QTc studies;Zhang;J biopharmaceutical statistics,2008

4. Creation of a knowledge management system for QT analyses;Tornøe;J ClinPharmacol,2011

5. Exposure-response modeling of QT prolongation for clinical studies;Needleman;Presentation at the optimising QT working group teleconference on,2011

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