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)

ICH Quality Guidelines: An Implementation Guide

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£288.95

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Hardback by Andrew Teasdale , David Elder

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Short Description:

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view... Read more

    Publisher: John Wiley & Sons Inc
    Publication Date: 15/12/2017
    ISBN13: 9781118971116, 978-1118971116
    ISBN10: 1118971116

    Number of Pages: 736

    Non Fiction , Technology, Engineering & Agriculture , Education

    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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