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

The American heart journal, 2012-06, Vol.163 (6), p.912-930

2012

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

Journal of clinical pharmacology, 2011-08, Vol.51 (8), p.1152-1162

2011

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Applying Decision Analysis to Inform the US Food and Drug Administration's Benefit-Risk Assessment of Ticagrelor for Primary Prevention of Myocardial Infarction or Stroke Based on THEMIS

Circulation (New York, N.Y.), 2021-08, Vol.144 (8), p.655-658

2021

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Assessing proarrhythmic potential of drugs when optimal studies are infeasible

The American heart journal, 2009-05, Vol.157 (5), p.827-836.e1

2009

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Enrichment Benefits of Risk Algorithms for Pulmonary Arterial Hypertension Clinical Trials

American journal of respiratory and critical care medicine, 2021-03, Vol.203 (6), p.726-736

2021

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Electrocardiographic assessment for therapeutic proteins—scientific discussion

The American heart journal, 2010-10, Vol.160 (4), p.627-634

2010

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Pharmacokinetics and Pharmacodynamics of Three Moxifloxacin Dosage Forms: Implications for Blinding in Active-Controlled Cardiac Repolarization Studies

Journal of clinical pharmacology, 2010-11, Vol.50 (11), p.1249-1259

2010

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Thorough QT Studies: Questions and Quandaries

Drug safety, 2010, Vol.33 (1), p.1-14

2010

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Concentration-QT Relationships Play a Key Role in the Evaluation of Proarrhythmic Risk During Regulatory Review

Journal of clinical pharmacology, 2008-01, Vol.48 (1), p.13-18

2008

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Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions: A Review of 198 Submissions Between 2000 and 2008

Clinical pharmacokinetics, 2011-10, Vol.50 (10), p.627-635

2011

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

British journal of clinical pharmacology, 2014-03, Vol.77 (3), p.522-531

2014

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Understanding Circadian Mechanisms of Sudden Cardiac Death: A Report From the National Heart, Lung, and Blood Institute Workshop, Part 1: Basic and Translational Aspects

Circulation. Arrhythmia and electrophysiology, 2021-11, Vol.14 (11), p.e010181-e010181

2021

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Creation of a Knowledge Management System for QT Analyses

Journal of clinical pharmacology, 2011-07, Vol.51 (7), p.1035-1042

2011

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Understanding Circadian Mechanisms of Sudden Cardiac Death: A Report From the National Heart, Lung, and Blood Institute Workshop, Part 2: Population and Clinical Considerations

Circulation. Arrhythmia and electrophysiology, 2021-11, Vol.14 (11), p.e010190-e010190

2021

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

Therapeutic innovation & regulatory science, 2023-01, Vol.57 (1), p.109-120

2023

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Clinical pharmacology as a cornerstone of orphan drug development

Nature reviews. Drug discovery, 2011-11, Vol.10 (11), p.795-796

2011

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Considerations for Clinical Trial Design and Data Analyses of Thorough QT Studies Using Drug-Drug Interaction

Journal of clinical pharmacology, 2010-10, Vol.50 (10), p.1106-1111

2010

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IMPROVING OUR UNDERSTANDING OF THE RELATIONSHIP BETWEEN QT PROLONGATION AND RISK OF TORSADE DE POINTES USING A QUANTITATIVE MODELING APPROACH

Journal of the American College of Cardiology, 2014-04, Vol.63 (12), p.A305-A305

2014

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Personal digital assistant-based drug reference software as tools to improve rational prescribing: Benchmark criteria and performance

Clinical pharmacology and therapeutics, 2005-07, Vol.78 (1), p.7-18

2005

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IMPROVING OUR UNDERSTANDING OF THE RELATIONSHIP BETWEEN QT PROLONGATION AND RISK OF TORSADE DE POINTES USING A QUANTITATIVE MODELING APPROACH

Journal of the American College of Cardiology, 2014, Vol.63 (12), p.A305-A305

2014

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Different Anesthetic Sensitivities of Skeletal and Cardiac Isoforms of the Ca-ATPase

Biochemistry (Easton), 1999-07, Vol.38 (29), p.9301-9307

1999

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

British journal of clinical pharmacology, 2014-03, Vol.77 (3), p.522-531

2014

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Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions

Clinical pharmacokinetics, 2011-10, Vol.50 (10), p.627

2011

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The HIV response beyond 2030: preparing for decades of sustained HIV epidemic control in eastern and southern Africa

The Lancet (British edition), 2024-08, Vol.404 (10453), p.638-641

2024

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

Journal of pediatric gastroenterology and nutrition, 2017-09, Vol.65 (3), p.272-277

2017

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

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

Applying Decision Analysis to Inform the US Food and Drug Administration's Benefit-Risk Assessment of Ticagrelor for Primary Prevention of Myocardial Infarction or Stroke Based on THEMIS

Assessing proarrhythmic potential of drugs when optimal studies are infeasible

Enrichment Benefits of Risk Algorithms for Pulmonary Arterial Hypertension Clinical Trials

Electrocardiographic assessment for therapeutic proteins—scientific discussion

Pharmacokinetics and Pharmacodynamics of Three Moxifloxacin Dosage Forms: Implications for Blinding in Active-Controlled Cardiac Repolarization Studies

Thorough QT Studies: Questions and Quandaries

Concentration-QT Relationships Play a Key Role in the Evaluation of Proarrhythmic Risk During Regulatory Review

Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions: A Review of 198 Submissions Between 2000 and 2008

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

Understanding Circadian Mechanisms of Sudden Cardiac Death: A Report From the National Heart, Lung, and Blood Institute Workshop, Part 1: Basic and Translational Aspects

Creation of a Knowledge Management System for QT Analyses

Understanding Circadian Mechanisms of Sudden Cardiac Death: A Report From the National Heart, Lung, and Blood Institute Workshop, Part 2: Population and Clinical Considerations

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

Clinical pharmacology as a cornerstone of orphan drug development

Considerations for Clinical Trial Design and Data Analyses of Thorough QT Studies Using Drug-Drug Interaction

IMPROVING OUR UNDERSTANDING OF THE RELATIONSHIP BETWEEN QT PROLONGATION AND RISK OF TORSADE DE POINTES USING A QUANTITATIVE MODELING APPROACH

Personal digital assistant-based drug reference software as tools to improve rational prescribing: Benchmark criteria and performance

IMPROVING OUR UNDERSTANDING OF THE RELATIONSHIP BETWEEN QT PROLONGATION AND RISK OF TORSADE DE POINTES USING A QUANTITATIVE MODELING APPROACH

Different Anesthetic Sensitivities of Skeletal and Cardiac Isoforms of the Ca-ATPase

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

Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions

The HIV response beyond 2030: preparing for decades of sustained HIV epidemic control in eastern and southern Africa

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

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