The Pharmaceutical Regulatory Process 2024 pdf epub mobi 电子书

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发表于2024-12-25

The Pharmaceutical Regulatory Process 2024 pdf epub mobi 电子书

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出版者:

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

出品人:

页数:650

译者:

出版时间:2008-12

价格:$ 282.50

装帧:

isbn号码:9781420070422

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The Pharmaceutical Regulatory Process 2024 pdf epub mobi 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

The Pharmaceutical Regulatory Process 2024 pdf epub mobi 电子书

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