Predicting drug‐induced QT prolongation and torsades de pointes

DM Roden - The Journal of physiology, 2016 - Wiley Online Library
Drugs used to treat cardiovascular disease as well as those used in the treatment of multiple
other conditions can occasionally produce exaggerated prolongation of the QT interval on …

[HTML][HTML] A platform for generation of chamber-specific cardiac tissues and disease modeling

Y Zhao, N Rafatian, NT Feric, BJ Cox, R Aschar-Sobbi… - Cell, 2019 - cell.com
Tissue engineering using cardiomyocytes derived from human pluripotent stem cells holds a
promise to revolutionize drug discovery, but only if limitations related to cardiac chamber …

[HTML][HTML] The comprehensive in vitro proarrhythmia assay (CiPA) initiative—update on progress

T Colatsky, B Fermini, G Gintant, JB Pierson… - … of pharmacological and …, 2016 - Elsevier
The implementation of the ICH S7B and E14 guidelines has been successful in preventing
the introduction of potentially torsadogenic drugs to the market, but it has also unduly …

An evaluation of 30 clinical drugs against the comprehensive in vitro proarrhythmia assay (CiPA) proposed ion channel panel

WJ Crumb Jr, J Vicente, L Johannesen… - … of pharmacological and …, 2016 - Elsevier
Abstract Introduction The Comprehensive in vitro Proarrhythmia Assay (CiPA) is intended to
address the misidentification of drug-associated torsade de pointes risk based solely on …

Late sodium current block for drug‐induced long QT syndrome: results from a prospective clinical trial

L Johannesen, J Vicente, JW Mason… - Clinical …, 2016 - Wiley Online Library
Drug‐induced long QT syndrome has resulted in many drugs being withdrawn from the
market. At the same time, the current regulatory paradigm for screening new drugs causing …

A computational pipeline to predict cardiotoxicity: from the atom to the rhythm

PC Yang, KR DeMarco, P Aghasafari, MT Jeng… - Circulation …, 2020 - ahajournals.org
Rationale: Drug-induced proarrhythmia is so tightly associated with prolongation of the QT
interval that QT prolongation is an accepted surrogate marker for arrhythmia. But QT interval …

New science, drug regulation, and emergent public health issues: The work of FDA's division of applied regulatory science

K Chiu, R Racz, K Burkhart, J Florian, K Ford… - Frontiers in …, 2023 - frontiersin.org
The US Food and Drug Administration (FDA) Division of Applied Regulatory Science
(DARS) moves new science into the drug review process and addresses emergent …

Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing's syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial

M Fleseriu, R Pivonello, A Elenkova… - The Lancet Diabetes & …, 2019 - thelancet.com
Background Levoketoconazole is a ketoconazole stereoisomer in development for treatment
of Cushing's syndrome and has not been assessed previously in a clinical trial in patients …