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Targeted Regulatory Writing Techniques Clinical Documents for Drugs and Biologics

ISBN-10: 3764383615
ISBN-13: 9783764383619
Edition: 2009
List price: $89.99 Buy it from $50.65
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Description: The secrets of regulatory writing for clinical documents in the drug and biologics industry in the three major regions of the world are revealed in this book. d.

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Book details

List price: $89.99
Copyright year: 2009
Publisher: Birkhauser Boston
Publication date: 11/18/2008
Binding: Paperback
Pages: 238
Size: 6.25" wide x 9.25" long x 0.50" tall
Weight: 1.188

The secrets of regulatory writing for clinical documents in the drug and biologics industry in the three major regions of the world are revealed in this book. d.

Regulatory writing fundamentals
Developing a target
Getting started
Regulatory writing tips
Templates and style guides: The nuts and bolts of regulatory documents
Document review
Source documents
Protocols
Clinical study reports
Integrated documents
Investigator's brochures
Investigational medicinal products dossier
Integrated summaries of safety and efficacy
Informed consent forms
Regulatory submissions
Global submissions: The common technical document
Clinical trial procedures and approval processes in Japan
Region-specific submissions: United States of America
Appendices I-XIV
Glossary and abbreviations
Index

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