ICH Quality Guidelines: An Implementation Guide 1st

ICH Quality Guidelines: An Implementation Guide 1st

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by Andrew Teasdale (Editor),‎ David Elder (Editor),‎ Raymond W. Nims (Editor)

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    ICH Quality Guidelines: An Implementation Guide 1st 

    by Andrew Teasdale (Editor),‎ David Elder (Editor),‎ Raymond W. Nims (Editor)

    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)

     

    Product details

    • Hardcover: 736 pages
    • Publisher: Wiley; 1 edition (October 9, 2017)
    • Language: English
    • Format:  PDF  Original 
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