Linear mixed‐effects model of QTc prolongation for olmesartan medoxomil
Author:
Affiliation:
1. Daiichi Sankyo Pharma DevelopmentEdisonNJUSA
2. Daiichi Sankyo Co, LtdTokyoJapan
Funder
Daiichi Sankyo Pharma Development
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.572
Reference13 articles.
1. Benicar (olmesartan medoxomil) tablets product label by Daiichi Sankyo Inc. (revised 02/ 2010).http://www.accessdata.fda.gov/Scripts/cder/Drugsat FDA
2. Olmesartan for the Delay or Prevention of Microalbuminuria in Type 2 Diabetes
3. Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study
4. US Food and Drug Administration. Guidance for industry: E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non‐antiarrhythmic drugs.2005.http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073153.pdf. Accessed April 28 2015.
5. A thorough QTc study demonstrates that olmesartan medoxomil does not prolong the QTc interval
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1. Assessing QT/QTc interval prolongation with concentration-QT modeling for Phase I studies: impact of computational platforms, model structures and confidence interval calculation methods;Journal of Pharmacokinetics and Pharmacodynamics;2018-03-19
2. Population pharmacokinetics of moxifloxacin and its concentration–QT interval relationship modeling in Chinese healthy volunteers;Acta Pharmacologica Sinica;2017-07-17
3. Estimation of QT interval prolongation through model-averaging;Journal of Pharmacokinetics and Pharmacodynamics;2017-04-18
4. Population Pharmacokinetic Modeling of Olmesartan, the Active Metabolite of Olmesartan Medoxomil, in Patients with Hypertension;European Journal of Drug Metabolism and Pharmacokinetics;2016-08-17
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