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Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics Paperback – December 5, 2008

ISBN-13: 978-3764383619 ISBN-10: 3764383615 Edition: 2009th
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Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics + FDA Regulatory Affairs: Third Edition
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Product Details

  • Paperback: 238 pages
  • Publisher: Birkhäuser; 2009 edition (December 5, 2008)
  • Language: English
  • ISBN-10: 3764383615
  • ISBN-13: 978-3764383619
  • Product Dimensions: 6.2 x 0.6 x 9 inches
  • Shipping Weight: 15.5 ounces (View shipping rates and policies)
  • Average Customer Review: 4.5 out of 5 stars  See all reviews (6 customer reviews)
  • Amazon Best Sellers Rank: #715,159 in Books (See Top 100 in Books)

Customer Reviews

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13 of 13 people found the following review helpful By Jay Herson on July 29, 2009
Format: Paperback Verified Purchase
While ICH has told the global clinical development community what they want there has been confusion as to how to implement the guidelines. The confusion is particularly acute in the small biotech firms where MDs, PhDs and PharmDs are given the sole authority to write protocols, clinical study reports, integrated summaries of safety and efficacy without the oversight and SOPs that guide these steps in Big Pharma. Wood and Foote have created an outstanding book which should serve as a reference for clinical development professionals worldwide. Through clear narratives and templates they tell the reader how to create all the documents needed in a clinical development program even including this information for Japan which has long been a source of confusion even in Big Pharma.
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16 of 19 people found the following review helpful By C. Strecker on July 4, 2009
Format: Kindle Edition
This is a fine reference book. But, it is NOT well served by the Kindle. The tables are almost impossible to read, even with the zoom plus a magnifying glass. (The zoom hardly enlarges the tables and figures at all.) It is also the kind of book that you want to refer to "as needed" for certain types of documents. Navigating to the pages you want to refer to is extremely difficult. Get the paper version for this one!
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1 of 1 people found the following review helpful By Burke on April 10, 2014
Format: Paperback Verified Purchase
This is a must have for medical writers. Hands down.
This is THE book for medical writers who prepare documents for regulatory submissions. I have been a medical writer for over 20 years and still find useful information and reminders for documents I prepare. The writer is clear and concise and the examples are useful and pertinent. This would make a great reference and teaching book for a newer medical writer also as each document type is presented, from protocols and Investigator's Brochures to Clinical Study Reports.
This book belongs in every medical writer's reference library.
A great investment book for writers and companies.
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