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

Clinical pharmacology and therapeutics, 2018-01, Vol.103 (1), p.54-66

2018

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Orthopedic Coordinated Registry Network (Ortho-CRN): advanced infrastructure for real-world evidence generation

BMJ surgery, interventions, & health technologies, 2022-11, Vol.4 (Suppl 1), p.e000073

2022

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The Maastricht-Duke Bridge: an Era of Mentoring in Clinical Research – A Model for Mentoring in Clinical Research - A Tribute to Dr. Galen Wagner

Journal of electrocardiology, 2017-01, Vol.50 (1), p.16-20

2017

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Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX Balloon Expandable Endoprosthesis

BMJ surgery, interventions, & health technologies, 2022-07, Vol.4 (1), p.e000085-e000085

2022

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Safety and Effectiveness of Medical Device Therapy

Sex-Specific Analysis of Cardiovascular Function, 2018, Vol.1065, p.107-121

2018

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Comparative Effectiveness of Cardiac Resynchronization Therapy Defibrillators Versus Standard Implantable Defibrillators in Medicare Patients

The American journal of cardiology, 2015-07, Vol.116 (1), p.79-84

2015

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Left ventricular regional contraction abnormalities by echocardiographic speckle tracking in combined right bundle branch with left anterior fascicular block compared to left bundle branch block

Journal of electrocardiology, 2016-05, Vol.49 (3), p.353-361

2016

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Prevalence of manual Strauss LBBB criteria in patients diagnosed with the automated Glasgow LBBB criteria

Journal of electrocardiology, 2015-07, Vol.48 (4), p.558-564

2015

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Sex-Specific Mortality Risk by QRS Morphology and Duration in Patients Receiving CRT

Journal of the American College of Cardiology, 2014-09, Vol.64 (9), p.887-894

2014

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Sex Differences of Patients With Systemic Hypertension (From the Analysis of the Systolic Blood Pressure Intervention Trial [SPRINT])

The American journal of cardiology, 2018-09, Vol.122 (6), p.985-993

2018

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Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial

JAMA : the journal of the American Medical Association, 2019-06, Vol.321 (21), p.2082

2019

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Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial

JAMA : the journal of the American Medical Association, 2020-01, Vol.323 (3), p.256

2020

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Influence of QRS infarct score and QRS duration prior to transcatheter aortic valve replacement on follow-up left ventricular end systolic volume in patients with new persistent left bundle branch block

Journal of electrocardiology, 2015-07, Vol.48 (4), p.637-642

2015

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

Clinical pharmacology and therapeutics, 2019-04, Vol.105 (4), p.943-953

2019

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Cardiac resynchronization therapy in women: US Food and Drug Administration meta-analysis of patient-level data

JAMA internal medicine, 2014-08, Vol.174 (8), p.1340

2014

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Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions

Clinical pharmacology and therapeutics, 2023-08, Vol.114 (2), p.325-355

2023

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Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA): A Randomized Clinical Trial

JAMA : the journal of the American Medical Association, 2021-07, Vol.326 (3), p.240

2021

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Novel simultaneous method for the determination of avobenzone and oxybenzone in human plasma by UHPLC-MS/MS with phospholipid removal pretreatment: An application to a sunscreen clinical trial

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 2021-04, Vol.1169, p.122615, Article 122615

2021

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Regulatory and HTA Considerations for Development of Real‐World Data Derived External Controls

Clinical pharmacology and therapeutics, 2023-08, Vol.114 (2), p.303-315

2023

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Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies

Clinical pharmacology and therapeutics, 2020-01, Vol.107 (1), p.40-42

2020

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Sex-Specific Mortality Risk by QRS Morphology and Duration in Patients Receiving CRT: Results From the NCDR

Journal of the American College of Cardiology, 2014-09, Vol.64 (9), p.887-894

2014

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Novel High-Throughput Quantitation of Potent hERG Blocker Dofetilide in Human Plasma by Liquid Chromatography Tandem Mass Spectrometry: Application in a Phase 1 ECG Biomarker Validation Study

Journal of analytical toxicology, 2020-03, Vol.44 (2), p.180-187

2020

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Food and Drug Administration Beyond the 2001 Government Accountability Office Report: Promoting Drug Safety for Women

Journal of women's health (Larchmont, N.Y. 2002), 2021-07, Vol.30 (7), p.927-934

2021

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The 43rd International Society for Computerized Electrocardiology ECG initiative for the automated detection of strict left bundle branch block

Journal of electrocardiology, 2018-11, Vol.51 (6), p.S25-S30

2018

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Sex-specific Long-term Outcomes of Watchman Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

Journal of the Society for Cardiovascular Angiography & Interventions, 2023-01, Vol.2 (1), p.100541, Article 100541

2023

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

Orthopedic Coordinated Registry Network (Ortho-CRN): advanced infrastructure for real-world evidence generation

The Maastricht-Duke Bridge: an Era of Mentoring in Clinical Research – A Model for Mentoring in Clinical Research - A Tribute to Dr. Galen Wagner

Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Safety and Effectiveness of Medical Device Therapy

Comparative Effectiveness of Cardiac Resynchronization Therapy Defibrillators Versus Standard Implantable Defibrillators in Medicare Patients

Left ventricular regional contraction abnormalities by echocardiographic speckle tracking in combined right bundle branch with left anterior fascicular block compared to left bundle branch block

Prevalence of manual Strauss LBBB criteria in patients diagnosed with the automated Glasgow LBBB criteria

Sex-Specific Mortality Risk by QRS Morphology and Duration in Patients Receiving CRT

Sex Differences of Patients With Systemic Hypertension (From the Analysis of the Systolic Blood Pressure Intervention Trial [SPRINT])

Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial

Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial

Influence of QRS infarct score and QRS duration prior to transcatheter aortic valve replacement on follow-up left ventricular end systolic volume in patients with new persistent left bundle branch block

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

Cardiac resynchronization therapy in women: US Food and Drug Administration meta-analysis of patient-level data

Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions

Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA): A Randomized Clinical Trial

Novel simultaneous method for the determination of avobenzone and oxybenzone in human plasma by UHPLC-MS/MS with phospholipid removal pretreatment: An application to a sunscreen clinical trial

Regulatory and HTA Considerations for Development of Real‐World Data Derived External Controls

Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies

Sex-Specific Mortality Risk by QRS Morphology and Duration in Patients Receiving CRT: Results From the NCDR

Novel High-Throughput Quantitation of Potent hERG Blocker Dofetilide in Human Plasma by Liquid Chromatography Tandem Mass Spectrometry: Application in a Phase 1 ECG Biomarker Validation Study

Food and Drug Administration Beyond the 2001 Government Accountability Office Report: Promoting Drug Safety for Women

The 43rd International Society for Computerized Electrocardiology ECG initiative for the automated detection of strict left bundle branch block

Sex-specific Long-term Outcomes of Watchman Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

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