Evaluation of dependent variable, time effect, covariates, and covariation structure in concentration-QTc modeling: A simulation study-Reference-Cited by-同舟云学术

Evaluation of dependent variable, time effect, covariates, and covariation structure in concentration-QTc modeling: A simulation study

Published:2018-06-28 Issue: Volume: Page:
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Huang Dalong Patrick¹^ORCID,Xiao Shan²,Dang Qianyu¹,Tsong Yi¹

Affiliation:

1. US Food and Drug Administration; Office of Biostatics, Office of Translational Sciences, Center for Drug Evaluation and Research; Silver Spring MD USA

2. Biogen Inc.; Cambridge MA USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pst.1874/fullpdf

Reference12 articles.

1. 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

2. Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase;Darpo;Clin Pharmacol Ther,2015

3. International Conference on Harmonisation, ICH E14 Implementation Working Group 2014

4. ICH E14 guideline: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs 2015

5. ICH E14 guidance: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Geneva 2005

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