Concentration-QTc analysis with two or more correlated baselines
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology
Link
https://link.springer.com/content/pdf/10.1007/s10928-021-09758-9.pdf
Reference23 articles.
1. ICH E14 Implementation Working Group (2015) The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions & Answers (R3). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Q_As_R3__Step4.pdf
2. Garnett C, Bonate PL, Dang Q et al (2018) Scientific white paper on concentration-QTc modeling. J Pharmacokinet Pharmacodyn 45:383–397. https://doi.org/10.1007/s10928-017-9558-5
3. Orihashi Y, Kumagai Y, Shiosakai K (2021) Novel concentration-QTc models for early clinical studies with parallel placebo controls: a simulation study. Pharm Stat 20:375–389. https://doi.org/10.1002/pst.2083
4. Kenward MG, Roger JH (2010) The use of baseline covariates in crossover studies. Biostatistics 11:1–17. https://doi.org/10.1093/biostatistics/kxp046
5. Lu K (2013) An efficient and robust analysis of covariance model for baseline adjustment in parallel-group thorough QT/QTc studies. Stat Med 32:2406–2418. https://doi.org/10.1002/sim.5614
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