Cardiac Safety of Noncardiac Drugs (eBook, PDF)
Practical Guidelines for Clinical Research and Drug Development
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Cardiac Safety of Noncardiac Drugs (eBook, PDF)
Practical Guidelines for Clinical Research and Drug Development
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Produktdetails
- Verlag: Humana Press
- Erscheinungstermin: 10. Oktober 2007
- Englisch
- ISBN-13: 9781592598847
- Artikelnr.: 37347653
Part I. Introduction
Cardiac Safety of Noncardiac Drugs: Historical Recollections
Raymond John Lipicky
Part II. Preclinical and Pharmacogenomic Cardiac Safety Evaluations
Molecular Physiology of Ion Channels That Control Cardiac Repolarization
Jeanne M. Nerbonne and Robert S. Kass
Cellular, Molecular, and Pharmacologic Mechanisms Underlying Drug-Induced Cardiac Arrhythmogenesis
Charles Antzelevitch
hERG Assay, QT Liability, and Sudden Cardiac Death
Arthur M. Brown
Pharmacogenomics in Drug Development: When and How to Apply
Richard Judson and Arthur J. Moss
Part III. Clinical Methodologies and Technical Aspects of Assessing Cardiac Safety of Investigational Drugs: Focus on Cardiac Repolarization
Assessment of Ventricular Repolarization From Body-Surface ECGs in Humans
Jean-Philippe Couderc and Wojciech Zareba
ECG Acquisition and Signal Processing: 12-Lead ECG Acquisition
Justin L. Mortara
Digital 12-Lead Holter vs Standard Resting Supine Electrocardiogram for the Assessment of Drug-Induced QTc Prolongation: Assessment by Different Recording and Measurement Methods
Nenad Sarapa
Holter Monitoring for QT: The RR Bin Method in Depth
Fabio Badilini and Pierre Maison-Blanche\
Part IV. Application of Electrocardiology in Clinical Research
Fundamentals of ECG Interpretation in Clinical Research and Cardiac Safety Assessment
Ihor Gussak, Robert Kleiman, and Jeffrey S. Litwin
Design and Conduct of the Thorough Phase I ECG Trial for New Bioactive Drugs
Joel Morganroth
Use of ECGs in Support of Cardiac Safety in Phase II and III Clinical Trials
Martin P. Bedigian
Cardiac Arrhythmia Assessment in Phase IV Clinical Studies
Gerald A. Faich and Annette Stemhagen
Statistical Analysis Plans for ECG Data: Controlling the Intrinsic and Extrinsic Variability in QT Data
Alan S. Hollister and Timothy H Montague
Interpretation of Clinical ECG Data: Understanding the Risk From Non-Antiarrhythmic Drugs
Rashmi R. Shah
Part V. Regulatory Considerations
The FDA's Digital ECG Initiative and Its Impact on Clinical Trials
Barry D. Brown
Quality Control and Quality Assurance for Core ECG Laboratories
Amy M. Annand-Furlong
ECG Digital Communities and Electronic Reporting of Cardiac Safety Data: New Technologies for Reporting Digital ECG Data in Clinical Research Settings
Scott Grisanti and Robert Brown
Index
Cardiac Safety of Noncardiac Drugs: Historical Recollections
Raymond John Lipicky
Part II. Preclinical and Pharmacogenomic Cardiac Safety Evaluations
Molecular Physiology of Ion Channels That Control Cardiac Repolarization
Jeanne M. Nerbonne and Robert S. Kass
Cellular, Molecular, and Pharmacologic Mechanisms Underlying Drug-Induced Cardiac Arrhythmogenesis
Charles Antzelevitch
hERG Assay, QT Liability, and Sudden Cardiac Death
Arthur M. Brown
Pharmacogenomics in Drug Development: When and How to Apply
Richard Judson and Arthur J. Moss
Part III. Clinical Methodologies and Technical Aspects of Assessing Cardiac Safety of Investigational Drugs: Focus on Cardiac Repolarization
Assessment of Ventricular Repolarization From Body-Surface ECGs in Humans
Jean-Philippe Couderc and Wojciech Zareba
ECG Acquisition and Signal Processing: 12-Lead ECG Acquisition
Justin L. Mortara
Digital 12-Lead Holter vs Standard Resting Supine Electrocardiogram for the Assessment of Drug-Induced QTc Prolongation: Assessment by Different Recording and Measurement Methods
Nenad Sarapa
Holter Monitoring for QT: The RR Bin Method in Depth
Fabio Badilini and Pierre Maison-Blanche\
Part IV. Application of Electrocardiology in Clinical Research
Fundamentals of ECG Interpretation in Clinical Research and Cardiac Safety Assessment
Ihor Gussak, Robert Kleiman, and Jeffrey S. Litwin
Design and Conduct of the Thorough Phase I ECG Trial for New Bioactive Drugs
Joel Morganroth
Use of ECGs in Support of Cardiac Safety in Phase II and III Clinical Trials
Martin P. Bedigian
Cardiac Arrhythmia Assessment in Phase IV Clinical Studies
Gerald A. Faich and Annette Stemhagen
Statistical Analysis Plans for ECG Data: Controlling the Intrinsic and Extrinsic Variability in QT Data
Alan S. Hollister and Timothy H Montague
Interpretation of Clinical ECG Data: Understanding the Risk From Non-Antiarrhythmic Drugs
Rashmi R. Shah
Part V. Regulatory Considerations
The FDA's Digital ECG Initiative and Its Impact on Clinical Trials
Barry D. Brown
Quality Control and Quality Assurance for Core ECG Laboratories
Amy M. Annand-Furlong
ECG Digital Communities and Electronic Reporting of Cardiac Safety Data: New Technologies for Reporting Digital ECG Data in Clinical Research Settings
Scott Grisanti and Robert Brown
Index
Part I. Introduction
Cardiac Safety of Noncardiac Drugs: Historical Recollections
Raymond John Lipicky
Part II. Preclinical and Pharmacogenomic Cardiac Safety Evaluations
Molecular Physiology of Ion Channels That Control Cardiac Repolarization
Jeanne M. Nerbonne and Robert S. Kass
Cellular, Molecular, and Pharmacologic Mechanisms Underlying Drug-Induced Cardiac Arrhythmogenesis
Charles Antzelevitch
hERG Assay, QT Liability, and Sudden Cardiac Death
Arthur M. Brown
Pharmacogenomics in Drug Development: When and How to Apply
Richard Judson and Arthur J. Moss
Part III. Clinical Methodologies and Technical Aspects of Assessing Cardiac Safety of Investigational Drugs: Focus on Cardiac Repolarization
Assessment of Ventricular Repolarization From Body-Surface ECGs in Humans
Jean-Philippe Couderc and Wojciech Zareba
ECG Acquisition and Signal Processing: 12-Lead ECG Acquisition
Justin L. Mortara
Digital 12-Lead Holter vs Standard Resting Supine Electrocardiogram for the Assessment of Drug-Induced QTc Prolongation: Assessment by Different Recording and Measurement Methods
Nenad Sarapa
Holter Monitoring for QT: The RR Bin Method in Depth
Fabio Badilini and Pierre Maison-Blanche\
Part IV. Application of Electrocardiology in Clinical Research
Fundamentals of ECG Interpretation in Clinical Research and Cardiac Safety Assessment
Ihor Gussak, Robert Kleiman, and Jeffrey S. Litwin
Design and Conduct of the Thorough Phase I ECG Trial for New Bioactive Drugs
Joel Morganroth
Use of ECGs in Support of Cardiac Safety in Phase II and III Clinical Trials
Martin P. Bedigian
Cardiac Arrhythmia Assessment in Phase IV Clinical Studies
Gerald A. Faich and Annette Stemhagen
Statistical Analysis Plans for ECG Data: Controlling the Intrinsic and Extrinsic Variability in QT Data
Alan S. Hollister and Timothy H Montague
Interpretation of Clinical ECG Data: Understanding the Risk From Non-Antiarrhythmic Drugs
Rashmi R. Shah
Part V. Regulatory Considerations
The FDA's Digital ECG Initiative and Its Impact on Clinical Trials
Barry D. Brown
Quality Control and Quality Assurance for Core ECG Laboratories
Amy M. Annand-Furlong
ECG Digital Communities and Electronic Reporting of Cardiac Safety Data: New Technologies for Reporting Digital ECG Data in Clinical Research Settings
Scott Grisanti and Robert Brown
Index
Cardiac Safety of Noncardiac Drugs: Historical Recollections
Raymond John Lipicky
Part II. Preclinical and Pharmacogenomic Cardiac Safety Evaluations
Molecular Physiology of Ion Channels That Control Cardiac Repolarization
Jeanne M. Nerbonne and Robert S. Kass
Cellular, Molecular, and Pharmacologic Mechanisms Underlying Drug-Induced Cardiac Arrhythmogenesis
Charles Antzelevitch
hERG Assay, QT Liability, and Sudden Cardiac Death
Arthur M. Brown
Pharmacogenomics in Drug Development: When and How to Apply
Richard Judson and Arthur J. Moss
Part III. Clinical Methodologies and Technical Aspects of Assessing Cardiac Safety of Investigational Drugs: Focus on Cardiac Repolarization
Assessment of Ventricular Repolarization From Body-Surface ECGs in Humans
Jean-Philippe Couderc and Wojciech Zareba
ECG Acquisition and Signal Processing: 12-Lead ECG Acquisition
Justin L. Mortara
Digital 12-Lead Holter vs Standard Resting Supine Electrocardiogram for the Assessment of Drug-Induced QTc Prolongation: Assessment by Different Recording and Measurement Methods
Nenad Sarapa
Holter Monitoring for QT: The RR Bin Method in Depth
Fabio Badilini and Pierre Maison-Blanche\
Part IV. Application of Electrocardiology in Clinical Research
Fundamentals of ECG Interpretation in Clinical Research and Cardiac Safety Assessment
Ihor Gussak, Robert Kleiman, and Jeffrey S. Litwin
Design and Conduct of the Thorough Phase I ECG Trial for New Bioactive Drugs
Joel Morganroth
Use of ECGs in Support of Cardiac Safety in Phase II and III Clinical Trials
Martin P. Bedigian
Cardiac Arrhythmia Assessment in Phase IV Clinical Studies
Gerald A. Faich and Annette Stemhagen
Statistical Analysis Plans for ECG Data: Controlling the Intrinsic and Extrinsic Variability in QT Data
Alan S. Hollister and Timothy H Montague
Interpretation of Clinical ECG Data: Understanding the Risk From Non-Antiarrhythmic Drugs
Rashmi R. Shah
Part V. Regulatory Considerations
The FDA's Digital ECG Initiative and Its Impact on Clinical Trials
Barry D. Brown
Quality Control and Quality Assurance for Core ECG Laboratories
Amy M. Annand-Furlong
ECG Digital Communities and Electronic Reporting of Cardiac Safety Data: New Technologies for Reporting Digital ECG Data in Clinical Research Settings
Scott Grisanti and Robert Brown
Index