Quantitative Systems Pharmacology Models for a New International Cardiac Safety Regulatory Paradigm: An Overview of the Comprehensive In Vitro Proarrhythmia Assay In Silico Modelin...

por Li, Zhihua, Garnett, Christine, Strauss, David G.
Publicado 2019

Early Drug Discovery Prediction of Proarrhythmia Potential and Its Covariates

por Polak, Sebastian, Pugsley, Michael K., Stockbridge, Norman, Garnett, Christine, Wiśniowska, Barbara
Publicado 2015

Importance of QT/RR hysteresis correction in studies of drug-induced QTc interval changes

por Malik, Marek, Garnett, Christine, Hnatkova, Katerina, Johannesen, Lars, Vicente, Jose, Stockbridge, Norman
Publicado 2018

Correction to: Implications of Individual QT/RR Profiles—Part 1: Inaccuracies and Problems of Population-Specific QT/Heart Rate Corrections

por Malik, Marek, Garnett, Christine, Hnatkova, Katerina, Vicente, Jose, Johannesen, Lars, Stockbridge, Norman
Publicado 2019

Correction to: Implications of Individual QT/RR Profiles—Part 2: Zero QTc/RR Correlations Do Not Prove QTc Correction Accuracy in Studies of QTc Changes

por Malik, Marek, Garnett, Christine, Hnatkova, Katerina, Vicente, Jose, Johannesen, Lars, Stockbridge, Norman
Publicado 2019

Implications of Individual QT/RR Profiles—Part 1: Inaccuracies and Problems of Population-Specific QT/Heart Rate Corrections

por Malik, Marek, Garnett, Christine, Hnatkova, Katerina, Vicente, Jose, Johannesen, Lars, Stockbridge, Norman
Publicado 2018

Implications of Individual QT/RR Profiles—Part 2: Zero QTc/RR Correlations Do Not Prove QTc Correction Accuracy in Studies of QTc Changes

por Malik, Marek, Garnett, Christine, Hnatkova, Katerina, Vicente, Jose, Johannesen, Lars, Stockbridge, Norman
Publicado 2018

Errors of Fixed QT Heart Rate Corrections Used in the Assessment of Drug-Induced QTc Changes

por Hnatkova, Katerina, Vicente, Jose, Johannesen, Lars, Garnett, Christine, Stockbridge, Norman, Malik, Marek
Publicado 2019

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

por Strauss, David G., Wu, Wendy W., Li, Zhihua, Koerner, John, Garnett, Christine
Publicado 2021

Detection of T Wave Peak for Serial Comparisons of JTp Interval

por Hnatkova, Katerina, Vicente, Jose, Johannesen, Lars, Garnett, Christine, Strauss, David G., Stockbridge, Norman, Malik, Marek
Publicado 2019

Heart Rate Correction of the J-to-Tpeak Interval

por Hnatkova, Katerina, Vicente, Jose, Johannesen, Lars, Garnett, Christine, Strauss, David G., Stockbridge, Norman, Malik, Marek
Publicado 2019

Mechanistic Model‐Informed Proarrhythmic Risk Assessment of Drugs: Review of the “CiPA” Initiative and Design of a Prospective Clinical Validation Study

por Vicente, Jose, Zusterzeel, Robbert, Johannesen, Lars, Mason, Jay, Sager, Philip, Patel, Vikram, Matta, Murali K., Li, Zhihua, Liu, Jiang, Garnett, Christine, Stockbridge, Norman, Zineh, Issam, Strauss, David G.
Publicado 2017

The Challenges of Predicting Drug-Induced QTc Prolongation in Humans

por Valentin, Jean-Pierre, Hoffmann, Peter, Ortemann-Renon, Catherine, Koerner, John, Pierson, Jennifer, Gintant, Gary, Willard, James, Garnett, Christine, Skinner, Matthew, Vargas, Hugo M, Wisialowski, Todd, Pugsley, Michael K
Publicado 2022

Assessment of Multi‐Ion Channel Block in a Phase I Randomized Study Design: Results of the CiPA Phase I ECG Biomarker Validation Study

por Vicente, Jose, Zusterzeel, Robbert, Johannesen, Lars, Ochoa‐Jimenez, Roberto, Mason, Jay W., Sanabria, Carlos, Kemp, Sarah, Sager, Philip T., Patel, Vikram, Matta, Murali K., Liu, Jiang, Florian, Jeffry, Garnett, Christine, Stockbridge, Norman, Strauss, David G.
Publicado 2019

Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation

por Fleming, Thomas R., Garnett, Christine E., Conklin, Laurie S., Corriol-Rohou, Solange, Hariharan, Sudharshan, Hsu, Daphne, Mueller-Velten, Guenther, Mulugeta, Yeruk, Portman, Ronald, Rothmann, Mark D., Stockbridge, Norman L., Wandel, Simon, Zhang, Jialu, Yao, Lynne
Publicado 2022

New Strategies for the Conduct of Clinical Trials in Pediatric Pulmonary Arterial Hypertension: Outcome of a Multistakeholder Meeting With Patients, Academia, Industry, and Regulat...

por Ollivier, Cécile, Sun, Haihao, Amchin, Wayne, Beghetti, Maurice, Berger, Rolf M. F., Breitenstein, Stefanie, Garnett, Christine, Gullberg, Ninna, Hassel, Patrik, Ivy, Dunbar, Kawut, Steven M., Klein, Agnes, Lesage, Catherine, Migdal, Marek, Nije, Barbara, Odermarsky, Michal, Strait, James, de Graeff, Pieter A., Stockbridge, Norman
Publicado 2019