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Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

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Cover of 'Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics'

Table of Contents

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    Book Overview
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    Chapter 1 Developing a target
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    Chapter 2 Regulatory writing tips
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    Chapter 3 Templates and style guides: The nuts and bolts of regulatory documents
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    Chapter 4 Document review
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    Chapter 5 Protocols
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    Chapter 6 Clinical study reports
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    Chapter 7 Investigator’s brochures
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    Chapter 8 Investigational medicinal products dossier
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    Chapter 9 Integrated summaries of safety and efficacy
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    Chapter 10 Informed consent forms
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    Chapter 11 Global submissions: The common technical document
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    Chapter 12 Clinical trial procedures and approval processes in Japan
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    Chapter 13 Region-specific submissions: United States of America
Attention for Chapter 6: Clinical study reports
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