ICH Quality Guidelines: An Implementation Guide (PDF) - Afkebooks - Medical ebooks for Doctors

ICH Quality Guidelines: An Implementation Guide (PDF)

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Format: Publisher PDF

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published date: 25 May 23

by Andrew Teasdale (Editor), David Elder (Editor), Raymond W. Nims (Editor) _0

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
  • ISBN-10: 1118971116
  • ISBN-13: 978-1118971116
  • Product Dimensions: 6.2 x 1.5 x 9.2 inches

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