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New Drug Development

Overview of attention for book
Cover of 'New Drug Development'

Table of Contents

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    Book Overview
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    Chapter 1 New Drug Development
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    Chapter 2 The Regulatory Environment
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    Chapter 3 Drug Discovery
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    Chapter 4 Nonclinical Research
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    Chapter 5 Designing Clinical Trials
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    Chapter 6 Conducting Clinical Trials I: Experimental Methodology
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    Chapter 7 Conducting Clinical Trials II: Operational Execution
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    Chapter 8 Statistical Analysis
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    Chapter 9 Statistical Significance
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    Chapter 10 Clinical Significance
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    Chapter 11 Sample Size Estimation
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    Chapter 12 General Safety Assessments
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    Chapter 13 Efficacy Assessment
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    Chapter 14 Cardiac and Cardiovascular Safety Assessments
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    Chapter 15 Manufacturing Small Molecule Drugs and Biologicals
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    Chapter 16 Postmarketing Surveillance
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    Chapter 17 Main Themes and Concluding Comments
Attention for Chapter 2: The Regulatory Environment
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