The Pharmaceutical Regulatory Process

The Pharmaceutical Regulatory Process pdf epub mobi txt 电子书 下载 2025

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
丛书系列:
图书标签:
  • 药物法规
  • 制药监管
  • 法规遵从
  • 药物审批
  • 药物开发
  • 临床试验
  • 药品质量
  • 药品安全
  • 医疗保健政策
  • 生命科学
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具体描述

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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