4.7 Article

Characterization of a high throughput human stem cell cardiomyocyte assay to predict drug-induced changes in clinical electrocardiogram parameters

相关参考文献

注意:仅列出部分参考文献,下载原文获取全部文献信息。
Review Pharmacology & Pharmacy

Time for a Fully Integrated Nonclinical-Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective

Hugo M. Vargas et al.

Summary: Efficient assessment of drug-induced QTc prolongation remains a concern of drug developers and regulators worldwide. While successful, nonclinical evaluations currently have minimal impact on clinical QTc prolongation assessment. Fully integrating nonclinical and clinical data can simplify drug development processes.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2021)

Review Pharmacology & Pharmacy

Translational Models and Tools to Reduce Clinical Trials and Improve Regulatory Decision Making for QTc and Proarrhythmia Risk (ICH E14/S7B Updates)

David G. Strauss et al.

Summary: After certain drugs were withdrawn from the market due to the risk of drug-induced torsade de pointes (TdP), the ICH released guidelines focusing on the assessment of surrogate biomarkers for TdP in 2005. Vargas et al. proposed that double-negative nonclinical data may not require detailed clinical QTc evaluation due to low probability of QTc prolongation and TdP, leading to the ICH releasing a new Draft Guideline to address this. The ICH's new guidelines aim to reduce Thorough QT (TQT) studies using double-negative nonclinical data and achieving a low-risk determination in situations where TQT studies are not feasible.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2021)

Article Pharmacology & Pharmacy

A Bayesian approach to toxicological testing

James C. Felli et al.

JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS (2020)

Article Pharmacology & Pharmacy

Electrophysiological characterization of drug response in hSC-derived cardiomyocytes using voltage-sensitive optical platforms

Emily R. Pfeiffer-Kaushik et al.

JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS (2019)

Article Pharmacology & Pharmacy

Biophysical comparison of sodium currents in native cardiac myocytes and human induced pluripotent stem cell-derived cardiomyocytes

Robert J. Goodrow et al.

JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS (2018)

Article Pharmacology & Pharmacy

A new paradigm for drug-induced torsadogenic risk assessment using human iPS cell-derived cardiomyocytes

Hiroyuki Ando et al.

JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS (2017)

Article Pharmacology & Pharmacy

Correlation between human ether-a-go-go-related gene channel inhibition and action potential prolongation

P. Saxena et al.

BRITISH JOURNAL OF PHARMACOLOGY (2017)

Article Pharmacology & Pharmacy

Improved Prediction of Drug-Induced Torsades de Pointes Through Simulations of Dynamics and Machine Learning Algorithms

M. Cummins Lancaster et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2016)

Article Pharmacology & Pharmacy

Comparison of electrophysiological effects of calcium channel blockers on cardiac repolarization

Hyang-Ae Lee et al.

KOREAN JOURNAL OF PHYSIOLOGY & PHARMACOLOGY (2016)

Article Pharmacology & Pharmacy

Human ex-vivo action potential model for pro-arrhythmia risk assessment

Guy Page et al.

JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS (2016)

Article Pharmacology & Pharmacy

The Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative Update on progress

Thomas Colatsky et al.

JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS (2016)

Review Biochemical Research Methods

A New Perspective in the Field of Cardiac Safety Testing through the Comprehensive In Vitro Proarrhythmia Assay Paradigm

Bernard Fermini et al.

JOURNAL OF BIOMOLECULAR SCREENING (2016)

Article Chemistry, Multidisciplinary

A Photostable Silicon Rhodamine Platform for Optical Voltage Sensing

Yi-Lin Huang et al.

JOURNAL OF THE AMERICAN CHEMICAL SOCIETY (2015)

Article Cardiac & Cardiovascular Systems

Human-induced pluripotent stem cell-derived cardiomyocytes exhibit temporal changes in phenotype

Christine Y. Ivashchenko et al.

AMERICAN JOURNAL OF PHYSIOLOGY-HEART AND CIRCULATORY PHYSIOLOGY (2013)

Article Cardiac & Cardiovascular Systems

High purity human-induced pluripotent stem cell-derived cardiomyocytes: electrophysiological properties of action potentials and ionic currents

Junyi Ma et al.

AMERICAN JOURNAL OF PHYSIOLOGY-HEART AND CIRCULATORY PHYSIOLOGY (2011)

Article Pharmacology & Pharmacy

On the relationship between block of the cardiac Na+ channel and drug-induced prolongation of the QRS complex

A. R. Harmer et al.

BRITISH JOURNAL OF PHARMACOLOGY (2011)

Article Biochemical Research Methods

Simulation of the Undiseased Human Cardiac Ventricular Action Potential: Model Formulation and Experimental Validation

Thomas O'Hara et al.

PLOS COMPUTATIONAL BIOLOGY (2011)

Article Computer Science, Interdisciplinary Applications

Regularization Paths for Generalized Linear Models via Coordinate Descent

Jerome Friedman et al.

JOURNAL OF STATISTICAL SOFTWARE (2010)

Review Medicine, General & Internal

Drug therapy: Drug-induced prolongation of the QT interval

DM Roden

NEW ENGLAND JOURNAL OF MEDICINE (2004)

Article Cardiac & Cardiovascular Systems

Role of the cytosolic chaperones Hsp70 and Hsp90 in maturation of the cardiac potassium channel hERG

E Ficker et al.

CIRCULATION RESEARCH (2003)

Review Cardiac & Cardiovascular Systems

Genetic control of sodium channel function

HL Tan et al.

CARDIOVASCULAR RESEARCH (2003)