The Pharmaceutical Regulatory Process 在线电子书 pdf 下载 txt下载 epub 下载 mobi 下载 2024

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Berry, Ira R. (EDT)/ Martin, Robert P. (EDT) 作者

译者

2008-12 出版日期

650 页数

$ 282.50 价格

丛书系列

9781420070422 图书编码

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发表于2024-11-10

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The Pharmaceutical Regulatory Process 在线电子书 epub 下载 mobi 下载 pdf 下载 txt 下载 2024

The Pharmaceutical Regulatory Process 在线电子书 pdf 下载 txt下载 epub 下载 mobi 下载 2024

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The Pharmaceutical Regulatory Process 在线电子书图书描述

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.New chapters cover: ULLIthe marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance/LILIpharmacovigilance programs designed to prevent widespread safety issues/LILIlegal issues surrounding the sourcing of foreign APIs/LILIthe issues of counterfeit drugs/LILIupdates on quality standards/LI/UL

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