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Title: New Drug Development: A Regulatory Overview by Mark P. Mathieu, Mark Mathieu, Anne G. Evans, Parexel International Corporation ISBN: 1-882615-42-5 Publisher: Parexel Intl Corp Pub. Date: 01 June, 1997 Format: Paperback List Price(USD): $130.50

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Average Customer Rating: 5 (1 review)

Rating: 5
Summary: Gray's anatomy for regulatory affairs
Comment: I once was told that in drug development regulatory affairs there wasn't an equivalent to a Gray's anatomy or a Goodman & Gilman's pharmacology textbook. Thus I had to jump right into the maze of FDA guidelines and the code of federal regulations (CFR). After I discovered and read the first few chapters of this book I went back to the experienced regulatory affairs person that told me that there wasn't such a textbook and said "here is Gray's anatomy for regulatory affairs!" Indeed, the book covers all regulatory aspects of drug development providing an extensive and clear description of all the regulatory requirements for each phase as well as providing an objective interpretation of the laws. What I most like about this book is that it is self-sufficient in that it summarizes and pulls the relevant guidances and regulations together for each phase in such a manner that the text flows easily and one does not have to stop reading it to look for the original guidance or CFR text. Even a copy of the relevant forms is included in each chapter (for instance form 1571 in the chapter about the IND) so that one can better follow the author's discussion about it. This self-sufficiency seems to be a major advantage of this book because in other regulatory manuals the norm seems to have a text full of links or advices to read the guidance before proceeding to the next sentence of the book which is annoying and many times unfeasible if you don't have immediate access to the myriad of FDA issued documents. Another good thing is that the author also provides down-to-earth but very important information such as who is the present director of a division, why did he/she achieved that position, who was the previous director, where/he she is right now. Overall it is the best textbook I've seen so far in regulatory affairs for prescription drugs.

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