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《ICH质量指南:实施指南 》新书2017年9月29日

ICH Quality Guidelines: An Implementation Guide (ICH质量指南:实施指南)

作者: Teasdale, Andrew (EDT)/ Elder, David (EDT)/ Nims, Raymond W. (EDT)
出版社:John Wiley & Sons Inc
出版日期:2017年9月29日
页数: 736页

使用案例研究来帮助读者理解和应用ICH指南, 为从业人员提供一个主要参考点,解决ICH指南解释和实际实施的双重挑战。

Description:
Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making.
• Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies
• Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines
• Uses case studies to help readers understand and apply ICH guidelines
• Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines
• Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)


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  1. #1

    看看!!!!!!!

    makelight4周前 (11-20)Reply