Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices Review

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(More customer reviews)written in a technically precise and easy-going manner, it covers well all items listed in the index. Allocation of tables and pictures sometimes far from the page one is reading, but no harm done. Overall it is an excellent book to align a team of RA professionals with the basics of the area.

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"This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing." –Microbiology Today, May 2009
Written in a clear and concise style by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices.
Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices.
The book covers everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

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Using and Understanding Medical Statistics Review

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(More customer reviews)For what this book intends, it truly is outstanding. In general, the medical researcher of any kind is at a severe disadvantage in dealing with professional biostatisticians because often the two do not speak a common language. This very readable, interesting and clearly written book gives the scientist enough knowledge to deal with most relatively simple cases in a language that we understand. With the basic principles of medical statistics made comprehensible, we are able to understand many of the simpler software packages well enough to perform basic statistical analyses and, more importantly, are able to converse intelligently with biostatistical professionals and to design studies that will pass muster. Unlike another reviewer, I do not feel that not covering SAS or other software programs is a disadvantage. No book can cover everything, and this book covers the basics and intermediate levels far better than any book I have seen, certainly better than any biostatistics book written by biostatisticians intended for other biostatisticians. This book understands that biostatistics is a tool, not a fundamental discipline, for the vast majority of scientists and is written to them. The book serves as a ready reference and review if one does not perform these analyses on a daily basis. This book should be on the shelf of every life scientist.

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