List of works - Christine Garnett

A Quantitative Framework to Evaluate Proarrhythmic Risk in a First-in-Human Study to Support Waiver of a Thorough QT Study.

scientific article published on 29 September 2015

A modeling and simulation approach to characterize methadone QT prolongation using pooled data from five clinical trials in MMT patients

scientific article

Are women more susceptible than men to drug-induced QT prolongation? Concentration-QTc modelling in a phase 1 study with oral rac-sotalol

scientific article

Assessing electrocardiographic data quality and possible replacement of pharmacologic positive control in thorough QT/QTc studies by investigations of drug-free QTc stability.

scientific article

Assessing proarrhythmic potential of drugs when optimal studies are infeasible.

scientific article published on May 2009

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

scientific article published on 18 January 2019

Can Bias Evaluation Provide Protection Against False-Negative Results in QT Studies Without a Positive Control Using Exposure-Response Analysis?

scientific article

Cardiac Safety Research Consortium: can the thorough QT/QTc study be replaced by early QT assessment in routine clinical pharmacology studies? Scientific update and a research proposal for a path forward.

scientific article published on 6 June 2014

Clinical pharmacology as a cornerstone of orphan drug development ⬇️

scholarly article by Edward D. Bashaw et al published 31 October 2011 in Nature Reviews Drug Discovery

Commentary on: "Levofloxacin-Induced QTc Prolongation Depends on the Time of Drug Administration".

scientific article published on 20 September 2016

Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review.

scientific article published on January 2008

Considerations for clinical trial design and data analyses of thorough QT studies using drug-drug interaction

scientific article

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

scientific article published on 01 March 2019

Correction to: Scientific white paper on concentration-QTc modeling

scientific article published on 12 January 2018

Creation of a Knowledge Management System for QT Analyses ⬇️

scientific article published on October 26, 2010

Dealing with global safety issues : was the response to QT-liability of non-cardiac drugs well coordinated?

scientific article published on March 2013

Detection of T Wave Peak for Serial Comparisons of JTp Interval

scientific article published on 25 July 2019

Different anesthetic sensitivities of skeletal and cardiac isoforms of the Ca-ATPase.

scientific article published in July 1999

Direct involvement of intracellular Ca2+ transport ATPase in the development of thapsigargin resistance by Chinese hamster lung fibroblasts.

scientific article published on May 1995

Early Drug Discovery Prediction of Proarrhythmia Potential and Its Covariates

scientific article published on 5 May 2015

Early QT assessment--how can our confidence in the data be improved?

scientific article

Electrocardiographic assessment for therapeutic proteins—scientific discussion ⬇️

scientific article published on October 1, 2010

Electrocardiographic data quality in thorough QT/QTc studies.

scientific article

Energy transduction and kinetic regulation by the peptide segment connecting phosphorylation and cation binding domains in transport ATPases.

scientific article published on August 1996

Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response

scientific article published on 19 November 2016

Highly Automated QT Measurement Techniques in 7 Thorough QT Studies Implemented under ICH E14 Guidelines ⬇️

scientific article published on January 1, 2011

Impact of electrocardiographic data quality on moxifloxacin response in thorough QT/QTc studies

scientific article

Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.

scientific article published on October 2011

Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14.

scientific article published in September 2015

Improving the assessment of heart toxicity for all new drugs through translational regulatory science.

scientific article published on 12 December 2013

Methodologies to characterize the QT/corrected QT interval in the presence of drug-induced heart rate changes or other autonomic effects.

scientific article published on 04 May 2012

New Strategies for the Conduct of Clinical Trials in Pediatric Pulmonary Arterial Hypertension: Outcome of a Multistakeholder Meeting With Patients, Academia, Industry, and Regulators, Held at the European Medicines Agency on Monday, June 12, 2017.

scientific article published in May 2019

Operational Characteristics of Linear Concentration-QT Models for Assessing QTc Interval in the Thorough QT and Phase I Clinical Studies.

scientific article

Pharmacokinetics and pharmacodynamics of three moxifloxacin dosage forms: implications for blinding in active-controlled cardiac repolarization studies.

scientific article published on 09 February 2010

Population Pharmacokinetic and Concentration-QTc Models for Moxifloxacin: Pooled Analysis of 20 Thorough QT Studies

scientific article published on 12 January 2011

Practice and challenges of thorough QT studies.

scientific article published on 19 September 2012

Response to letter to the editor: Statistical issues of QT prolongation assessment based on linear concentration modeling by Yi Tsong et al.

scientific article published in May 2010

Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase

scientific article published in April 2015

Scientific white paper on concentration-QTc modeling

scientific article published on 5 December 2017

Tasigna for chronic and accelerated phase Philadelphia chromosome--positive chronic myelogenous leukemia resistant to or intolerant of imatinib

scientific article

The Combination of Exposure-Response and Case-Control Analyses in Regulatory Decision Making

article

The IQ-CSRC prospective clinical Phase 1 study: "Can early QT assessment using exposure response analysis replace the thorough QT study?".

scientific article published on 30 December 2013

U.S. Food and Drug Administration approval: ruxolitinib for the treatment of patients with intermediate and high-risk myelofibrosis

scientific article

Vandetanib for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease: U.S. Food and Drug Administration drug approval summary.

scientific article published on 04 June 2012

List of works by Christine Garnett

A Quantitative Framework to Evaluate Proarrhythmic Risk in a First-in-Human Study to Support Waiver of a Thorough QT Study.

A modeling and simulation approach to characterize methadone QT prolongation using pooled data from five clinical trials in MMT patients

Are women more susceptible than men to drug-induced QT prolongation? Concentration-QTc modelling in a phase 1 study with oral rac-sotalol

Assessing electrocardiographic data quality and possible replacement of pharmacologic positive control in thorough QT/QTc studies by investigations of drug-free QTc stability.

Assessing proarrhythmic potential of drugs when optimal studies are infeasible.

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

Can Bias Evaluation Provide Protection Against False-Negative Results in QT Studies Without a Positive Control Using Exposure-Response Analysis?

Cardiac Safety Research Consortium: can the thorough QT/QTc study be replaced by early QT assessment in routine clinical pharmacology studies? Scientific update and a research proposal for a path forward.

Clinical pharmacology as a cornerstone of orphan drug development ⬇️

Commentary on: "Levofloxacin-Induced QTc Prolongation Depends on the Time of Drug Administration".

Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review.

Considerations for clinical trial design and data analyses of thorough QT studies using drug-drug interaction

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

Correction to: Scientific white paper on concentration-QTc modeling

Creation of a Knowledge Management System for QT Analyses ⬇️

Dealing with global safety issues : was the response to QT-liability of non-cardiac drugs well coordinated?

Detection of T Wave Peak for Serial Comparisons of JTp Interval

Different anesthetic sensitivities of skeletal and cardiac isoforms of the Ca-ATPase.

Direct involvement of intracellular Ca2+ transport ATPase in the development of thapsigargin resistance by Chinese hamster lung fibroblasts.

Early Drug Discovery Prediction of Proarrhythmia Potential and Its Covariates

Early QT assessment--how can our confidence in the data be improved?

Electrocardiographic assessment for therapeutic proteins—scientific discussion ⬇️

Electrocardiographic data quality in thorough QT/QTc studies.

Energy transduction and kinetic regulation by the peptide segment connecting phosphorylation and cation binding domains in transport ATPases.

Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response

Highly Automated QT Measurement Techniques in 7 Thorough QT Studies Implemented under ICH E14 Guidelines ⬇️

Impact of electrocardiographic data quality on moxifloxacin response in thorough QT/QTc studies

Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.

Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14.

Improving the assessment of heart toxicity for all new drugs through translational regulatory science.

Methodologies to characterize the QT/corrected QT interval in the presence of drug-induced heart rate changes or other autonomic effects.

New Strategies for the Conduct of Clinical Trials in Pediatric Pulmonary Arterial Hypertension: Outcome of a Multistakeholder Meeting With Patients, Academia, Industry, and Regulators, Held at the European Medicines Agency on Monday, June 12, 2017.

Operational Characteristics of Linear Concentration-QT Models for Assessing QTc Interval in the Thorough QT and Phase I Clinical Studies.

Pharmacokinetics and pharmacodynamics of three moxifloxacin dosage forms: implications for blinding in active-controlled cardiac repolarization studies.

Population Pharmacokinetic and Concentration-QTc Models for Moxifloxacin: Pooled Analysis of 20 Thorough QT Studies

Practice and challenges of thorough QT studies.

Response to letter to the editor: Statistical issues of QT prolongation assessment based on linear concentration modeling by Yi Tsong et al.

Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase

Scientific white paper on concentration-QTc modeling

Tasigna for chronic and accelerated phase Philadelphia chromosome--positive chronic myelogenous leukemia resistant to or intolerant of imatinib

The Combination of Exposure-Response and Case-Control Analyses in Regulatory Decision Making

The IQ-CSRC prospective clinical Phase 1 study: "Can early QT assessment using exposure response analysis replace the thorough QT study?".

U.S. Food and Drug Administration approval: ruxolitinib for the treatment of patients with intermediate and high-risk myelofibrosis

Vandetanib for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease: U.S. Food and Drug Administration drug approval summary.