Targeted Regulatory Writing Techniques Clinical Documents for Drugs and Biologics
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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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All the information you need in one place! Each Study Brief is a summary of one specific subject; facts, figures, and explanations to help you learn faster.
List price: $89.99
Copyright year: 2009
Publisher: Birkhauser Boston
Publication date: 11/18/2008
Size: 6.25" wide x 9.25" long x 0.50" tall
|Regulatory writing fundamentals|
|Developing a target|
|Regulatory writing tips|
|Templates and style guides: The nuts and bolts of regulatory documents|
|Clinical study reports|
|Investigational medicinal products dossier|
|Integrated summaries of safety and efficacy|
|Informed consent forms|
|Global submissions: The common technical document|
|Clinical trial procedures and approval processes in Japan|
|Region-specific submissions: United States of America|
|Glossary and abbreviations|