Overview
- Covers specific document types and submissions for drugs and biologics in the US, Japan and Europe. Extensive appendices of sample documents
- Comprehensive glossary of terms
- Written by two regulatory writers with more than 20 years experience each
- Includes supplementary material: sn.pub/extras
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Table of contents (13 chapters)
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Regulatory writing fundamentals
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Getting started
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Source documents
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Integrated documents
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Regulatory submissions
Keywords
About this book
Editors and Affiliations
Bibliographic Information
Book Title: Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics
Editors: Linda Fossati Wood, MaryAnn Foote
DOI: https://doi.org/10.1007/978-3-7643-8362-6
Publisher: Birkhäuser Basel
eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)
Copyright Information: Birkh�user Basel 2009
Softcover ISBN: 978-3-7643-8361-9Published: 18 November 2008
eBook ISBN: 978-3-7643-8362-6Published: 05 January 2009
Edition Number: 1
Number of Pages: X, 238
Number of Illustrations: 26 b/w illustrations
Topics: Pharmacology/Toxicology, Biotechnology, Pharmacy