Editors:
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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Front Matter
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Regulatory writing fundamentals
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Front Matter
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Getting started
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Front Matter
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Source documents
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Front Matter
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Integrated documents
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Front Matter
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Back Matter
About this book
Editors and Affiliations
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Medwrite Inc., Westford, USA
Linda Fossati Wood
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MA Foote Associates, Westlake Village, USA
MaryAnn Foote
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: Birkhäuser 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