Customer Reviews

Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

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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.

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!