Estimation of the Power of the Food Effect on QTc to Show Assay Sensitivity-Reference-Cited by-同舟云学术

Estimation of the Power of the Food Effect on QTc to Show Assay Sensitivity

Published:2017-08-17 Issue:1 Volume:58 Page:81-88
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Ferber Georg¹,Fernandes Sara²,Täubel Jörg²³

Affiliation:

1. Statistik Georg Ferber GmbH; Riehen Switzerland

2. Richmond Pharmacology Ltd; London UK

3. St Georges, University of London; London UK

Funder

Richmond Pharmacology Ltd.

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/jcph.975/fullpdf

Reference22 articles.

1. ICH E14 Questions & Answers (R3) December 10 2 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Q_As_R3__Step4.pdf 2015

2. Implications of the IQ-CSRC prospective study: time to revise ICH E14;Darpo;Drug Saf,2015

3. Can bias evaluation provide protection against false-negative results in QT studies without a positive control using exposure-response analysis?;Ferber;J Clin Pharmacol,2017

4. Establishing assay sensitivity in QT studies: experience with the use of moxifloxacin in an early phase clinical pharmacology study and comparison with its effect in a thorough QT study;Shah;Eur J Clin Pharmacol,2015

5. Can an early phase clinical pharmacology study replace a thorough QT study? Experience with a novel H3-receptor antagonist/inverse agonist;Shah;Eur J Clin Pharmacol,2016

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