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Tobin, John J./ Walsh, Gary 作者

译者

2008-9 出版日期

297 页数

$ 119.95 价格

丛书系列

9783527318773 图书编码

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Medical Product Regulatory Affairs 在线电子书 epub 下载 mobi 下载 pdf 下载 txt 下载 2024

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Medical Product Regulatory Affairs 在线电子书图书描述

"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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