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Author Details

Norman Stockbridge
Center for Drug Evaluation and Research
1978
172
44
PMIDPaper TitleJournal TitlePublished Year
36057747Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation.Ther Innov Regul Sci2023
37702218ICH S7B In Vitro Assays Do Not Address Mechanisms of QT<sub>C</sub> Prolongation for Peptides and Proteins - Data in Support of Not Needing Dedicated QT<sub>C</sub> Studies.Clin Pharmacol Ther2023
37286256Ventricular Arrhythmias Associated With Over-the-Counter and Recreational Opioids.J Am Coll Cardiol2023
37435958Lessons From COVID-19 for Pandemic Preparedness: Proceedings From a Multistakeholder Think Tank.Clin Infect Dis2023
36924142Patient-reported outcome measures and patient engagement in heart failure clinical trials: multi-stakeholder perspectives.Eur J Heart Fail2023
34699047Heart Failure Population with Therapeutic Response to Sacubitril/Valsartan, Spironolactone and Candesartan: FDA Perspective.Ther Innov Regul Sci2022
35831022Optimizing the Design and Analysis of Future AKI Trials.J Am Soc Nephrol2022
36578976Pulmonary hypertension in interstitial lung disease: Clinical trial design and endpoints: A consensus statement from the Pulmonary Vascular Research Institute's Innovative Drug Development Initiative-Group 3 Pulmonary Hypertension.Pulm Circ2022
36456063Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel.JACC Heart Fail2022
36016668Clinical significance of pulmonary hypertension in interstitial lung disease: A consensus statement from the Pulmonary Vascular Research Institute's innovative drug development initiative-Group 3 pulmonary hypertension.Pulm Circ2022
32937078Enrichment Benefits of Risk Algorithms for Pulmonary Arterial Hypertension Clinical Trials.Am J Respir Crit Care Med2021
34076243What can heart failure trialists learn from oncology trialists?Eur Heart J2021
33984319Days alive out of hospital in heart failure: Insights from the PARADIGM-HF and CHARM trials.Am Heart J2021
33406882Challenges of Cardio-Kidney Composite Outcomes in Large-Scale Clinical Trials.Circulation2021
33309582Treatment of HF in an Era of Multiple Therapies: Statement From the HF Collaboratory.JACC Heart Fail2021
33278832Thromboembolic and Hemorrhagic Outcomes in the Direct Oral Anticoagulant Trials Across the Spectrum of Kidney Function.Clin Pharmacol Ther2021
33017862Standardized definitions for evaluation of heart failure therapies: scientific expert panel from the Heart Failure Collaboratory and Academic Research Consortium.Eur J Heart Fail2020
32040191Effects of Electrical Stimulation on hiPSC-CM Responses to Classic Ion Channel Blockers.Toxicol Sci2020
31709525General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy.Clin Pharmacol Ther2020
31707323Clinical and regulatory landscape for cardiogenic shock: A report from the Cardiac Safety Research Consortium ThinkTank on cardiogenic shock.Am Heart J2020
33199251Standardized Definitions for Evaluation of Heart Failure Therapies: Scientific Expert Panel From the Heart Failure Collaboratory and Academic Research Consortium.JACC Heart Fail2020
33196311Benefit-Risk Tradeoffs in Assessment of New Drugs and Devices.Circulation2020
33183511Conduct of Clinical Trials in the Era of COVID-19: JACC Scientific Expert Panel.J Am Coll Cardiol2020
32943165Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI: JACC Scientific Expert Panel.J Am Coll Cardiol2020
28431138Cardiovascular outcome trials in patients with chronic kidney disease: challenges associated with selection of patients and endpoints.Eur Heart J2019
31841369Heart Failure End Points in Cardiovascular Outcome Trials of Sodium Glucose Cotransporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitus: A Critical Evaluation of Clinical and Regulatory Issues.Circulation2019
31636317Heart Rate Correction of the J-to-Tpeak Interval.Sci Rep2019
30255349Implications of Individual QT/RR Profiles-Part 1: Inaccuracies and Problems of Population-Specific QT/Heart Rate Corrections.Drug Saf2019
30255348Implications of Individual QT/RR Profiles-Part 2: Zero QTc/RR Correlations Do Not Prove QTc Correction Accuracy in Studies of QTc Changes.Drug Saf2019
30144016FDA Approval of Angiotensin II for the Treatment of Hypotension in Adults with Distributive Shock.Am J Cardiovasc Drugs2019
29954224Assessing Treatment Effects That Capture Disease Burden in Serious Chronic Diseases.Ther Innov Regul Sci2019
31402872Detection of T Wave Peak for Serial Comparisons of JTp Interval.Front Physiol2019
31401097Design of a "Lean" Case Report Form for Heart Failure Therapeutic Development.JACC Heart Fail2019
31600125Workshop Report: FDA Workshop on Improving Cardiotoxicity Assessment With Human-Relevant Platforms.Circ Res2019
31275152Errors of Fixed QT Heart Rate Corrections Used in the Assessment of Drug-Induced QTc Changes.Front Physiol2019
31088189New 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.J Am Heart Assoc2019
30731371Stroke prevention in atrial fibrillation: Closing the gap.Am Heart J2019
30852794Correction to: Implications of Individual QT/RR Profiles-Part 1: Inaccuracies and Problems of Population-Specific QT/Heart Rate Corrections.Drug Saf2019
30725335Correction to: Implications of Individual QT/RR Profiles-Part 2: Zero QTc/RR Correlations Do Not Prove QTc Correction Accuracy in Studies of QTc Changes.Drug Saf2019
30820768Correction to: FDA Approval of Angiotensin II for the Treatment of Hypotension in Adults with Distributive Shock.Am J Cardiovasc Drugs2019
30545975Clinical trial design and new therapies for pulmonary arterial hypertension.Eur Respir J2019
30447156Assessment of Multi-Ion Channel Block in a Phase I Randomized Study Design: Results of the CiPA Phase I ECG Biomarker Validation Study.Clin Pharmacol Ther2019
30610746Efficacy and Effectiveness Too Trials: Clinical Trial Designs to Generate Evidence on Efficacy and on Effectiveness in Wide Practice.Clin Pharmacol Ther2019
28925031Past, present, and future of acute heart failure clinical trials-a high-risk population in search of a strategy.Eur J Heart Fail2018
29802975Leveraging electronic health records for clinical research.Am Heart J2018
30071950Heart Failure With Preserved Ejection Fraction Expert Panel Report: Current Controversies and Implications for Clinical Trials.JACC Heart Fail2018
30257217International Multisite Study of Human-Induced Pluripotent Stem Cell-Derived Cardiomyocytes for Drug Proarrhythmic Potential Assessment.Cell Rep2018
29920722Relationship between International Normalized Ratio and Outcomes in Modern Trials with Warfarin Controls.Pharmacotherapy2018
29754667Is there a role for pharmacokinetic/pharmacodynamic-guided dosing for novel oral anticoagulants?Am Heart J2018
29672845Drug-induced Proarrhythmia and Torsade de Pointes: A Primer for Students and Practitioners of Medicine and Pharmacy.J Clin Pharmacol2018
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Collaborators

Robert Temple
Co-authored papers 15
Philip T Sager
Inc., Canada Cardiovascular Research Institute, Stanford University
Co-authored papers 15
John R Teerlink
Cardiology University of California San Francisco (UCSF)
Co-authored papers 13
Robert M Califf
From the National Institutes of Health
Co-authored papers 11
Mihai Gheorghiade
Bluhm Cardiovascular Institute, Northwestern University Feingerg School of Medicine
Co-authored papers 11
JoAnn Lindenfeld
Vanderbilt University Medical Center
Co-authored papers 8
Gerasimos Filippatos
National and Kapodistrian University of Athens, Attikon University Hospital
Co-authored papers 7
William T Abraham
The Ohio State University
Co-authored papers 7
Gregg C Fonarow
David Geffen School of Medicine, University of California, Los Angeles Medical Center
Co-authored papers 7
John G F Cleland
British Heart Foundation Centre of Research Excellence, University of Glasgow
Co-authored papers 6
Gary Michael Felker
Duke University School of Medicine
Co-authored papers 6
Adrian F Hernandez
Duke University Medical Center
Co-authored papers 6
Dianne Murphy
Co-authored papers 5
Roxana Mehran
Co-authored papers 5
Dunbar Ivy
Heart Institute, Children's Hospital Colorado, University of Colorado
Co-authored papers 4
Jonathan P Piccini
Duke University, NC Duke Clinical Research Institute
Co-authored papers 4
James E Tcheng
Duke University
Co-authored papers 4
Kenneth W Mahaffey
Stanford University Medical School
Co-authored papers 4
Alexandre Mebazaa
INSERM UMR-S , Universite de Paris Cite
Co-authored papers 4
James E Udelson
Tufts Medical Center
Co-authored papers 3
Ileana L Pi??a
Thomas Jefferson University
Co-authored papers 3
Sean P Collins
Vanderbilt University School of Medicine
Co-authored papers 3
Bernard J Gersh
Mayo Clinic College of Medicine and Science
Co-authored papers 3
Eric D Peterson
University of Texas Southwestern Medical Center
Co-authored papers 3
Robert M Nelson
The Ottawa Hospital, University of Ottawa
Co-authored papers 3
Cynthia L Green
Duke University School of Medicine
Co-authored papers 3
David A Morrow
Brigham and Women's Hospital
Co-authored papers 3
Robert O Bonow
Northwestern University Feinberg School of Medicine
Co-authored papers 3
Milton Packer
Co-authored papers 3
Burkert Pieske
Charite University Medicine, Berlin Institute of Health (BIH)
Co-authored papers 3
Release 1.2