Targeted Regulatory Writing Techniques Clinical Documents for Drugs and Biologics

Name: Targeted Regulatory Writing Techniques Clinical Documents for Drugs and Biologics
Availability: InStock
ISBN: 9783764383619

ISBN-10: 3764383615

ISBN-13: 9783764383619

Edition: 2009

Authors: Linda Fossati Wood, MaryAnn Foote

List price: $89.99

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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.

Book details

List price: $89.99
Copyright year: 2009
Publisher: Springer Basel AG
Publication date: 11/18/2008
Binding: Paperback
Pages: 238
Size: 6.69" wide x 9.61" long x 0.50" tall
Weight: 1.078



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