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Cardiovascular Safety in Drug Development and Therapeutic Use

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Cover of 'Cardiovascular Safety in Drug Development and Therapeutic Use'

Table of Contents

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    Book Overview
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    Chapter 1 The Central Role of Cardiovascular Safety in Drug Development and Therapeutic Use
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    Chapter 2 Drug Structures and the Biological Basis of Drug Responses
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    Chapter 3 Cardiovascular Structure, Function, and Pathophysiology
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    Chapter 4 Analyzing and Reporting Efficacy Data
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    Chapter 5 Analyzing and Reporting Safety Data
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    Chapter 6 Meta-analysis, Group Sequential Study Designs, Centralized Endpoint Adjudication, and Composite Endpoints
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    Chapter 7 The Proarrhythmic Cardiac Safety Regulatory Landscape Circa 2005–2015: Drug-Induced hERG Channel Block and the Thorough QT/QTc Study
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    Chapter 8 QTc Exposure–Response Modeling as a Primary Methodology for Proarrhythmic Cardiac Safety Assessments
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    Chapter 9 The Comprehensive In Vitro Proarrhythmia Assay Initiative
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    Chapter 10 Oncology Drug Therapy: Cardiotoxicity and the Discipline of Cardio-oncology
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    Chapter 11 Blood Pressure Responses to Noncardiovascular Drugs in Development and Therapeutic Use
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    Chapter 12 The Genesis of Cardiovascular Safety Regulatory Landscapes for New Antidiabetic Drugs for Type 2 Diabetes
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    Chapter 13 Satisfying the Regulatory Requirements for New Antidiabetic Drugs for Type 2 Diabetes Most Expeditiously
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    Chapter 14 Postmarketing Cardiovascular Safety Considerations
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    Chapter 15 A Safety Perspective on Additional Aspects of Drug Development and Therapeutic Use
Attention for Chapter 4: Analyzing and Reporting Efficacy Data
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Chapter title
Analyzing and Reporting Efficacy Data
Chapter number 4
Book title
Cardiovascular Safety in Drug Development and Therapeutic Use
Published by
Springer International Publishing, July 2016
DOI 10.1007/978-3-319-40347-2_4
Book ISBNs
978-3-31-940345-8, 978-3-31-940347-2
Authors

J. Rick Turner, Dilip R. Karnad, Snehal Kothari