Can non‐clinical repolarization assays predict the results of clinical thorough QT studies? Results from a research consortium

Autor: Park, Eunjung, Gintant, Gary A, Bi, Daoqin, Kozeli, Devi, Pettit, Syril D, Pierson, Jennifer B, Skinner, Matthew, Willard, James, Wisialowski, Todd, Koerner, John, Valentin, Jean‐Pierre

Publikováno v: British Journal of Pharmacology

Background and Purpose Translation of non‐clinical markers of delayed ventricular repolarization to clinical prolongation of the QT interval corrected for heart rate (QTc) (a biomarker for torsades de pointes proarrhythmia) remains an issue in drug

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::04e11b21bbadc465bf6f12f824e4f688
http://europepmc.org/articles/PMC5786459

Can Nonclinical Repolarization Assays Predict the Results of Clinical Thorough QT Studies? A HESI-FDA Retrospective Analysis

Autor: Park, Eunjung, Gintant, Gary, Bi, Daoqin, Kozeli, Devi, Pettit, Syril, Pierson, Jennifer, Skinner, Matthew, Willard, James, Wisialowski, Todd, Koerner, John, Valentin, Jean-Pierre

Publikováno v: In Journal of Pharmacological and Toxicological Methods November-December 2017 88 Part 2:201-201

The impact of drug-related QT prolongation on FDA regulatory decisions

Autor: Park, Eunjung, Willard, James, Bi, Daoqin, Fiszman, Monica, Kozeli, Devi, Koerner, John

Publikováno v: In International Journal of Cardiology 12 October 2013 168(5):4975-4976

Rapid determination of N,N-diethyl-m-toluamide and permethrin in human plasma by gas chromatography-mass spectrometry and pyridostigmine bromide by high-performance liquid chromatography.

Autor: Cherstniakova SA; Division of Clinical Pharmacology and Medical Toxicology, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Bethesda, MD 20814, USA., Garcia GE, Strong J, Bi D, Weitz J, Roy MJ, Cantilena LR

Publikováno v: Journal of analytical toxicology [J Anal Toxicol] 2006 Jan-Feb; Vol. 30 (1), pp. 21-6.