PK/PD modeling of a clazosentan thorough QT study with hysteresis in concentration-QT and RR-QT-Reference-Cited by-同舟云学术

PK/PD modeling of a clazosentan thorough QT study with hysteresis in concentration-QT and RR-QT

Published:2021-01-02 Issue:2 Volume:48 Page:213-224
ISSN:1567-567X
Container-title:Journal of Pharmacokinetics and Pharmacodynamics
language:en
Short-container-title:J Pharmacokinet Pharmacodyn

Author:

Henrich Andrea^ORCID,Juif Pierre-Eric^ORCID,Dingemanse Jasper^ORCID,Krause Andreas^ORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology

Link

https://link.springer.com/content/pdf/10.1007/s10928-020-09728-7.pdf

Reference32 articles.

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2. ICH (2005) The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. https://database.ich.org/sites/default/files/E14_Guideline.pdf

3. Garnett C, Bonate PL, Dang Q, Ferber G, Huang D, Liu J, Mehrotra D, Riley S, Sager P, Tornoe C, Wang Y (2018) Scientific white paper on concentration-QTc modeling. J Pharmacokinet Pharmacodyn 45:383–397. https://doi.org/10.1007/s10928-017-9558-5

4. Garnett C, Needleman K, Liu J, Brundage R, Wang Y (2016) Operational characteristics of linear concentration-QT models for assessing QTc interval in the thorough QT and phase I clinical studies. Clin Pharmacol Ther 100:170–178. https://doi.org/10.1002/cpt.361

5. Glomb P, Ring A (2012) Delayed effects in the exposure-response analysis of clinical QTc trials. J Biopharm Stat 22:387–400. https://doi.org/10.1080/10543406.2010.539309

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