ICH Quality Guidelines: An Implementation Guide
| By: | Andrew Teasdale; David Elder; Raymond W. Nims |
| Publisher: | Wiley Global Research (STMS) |
| Print ISBN: | 9781118971116 |
| eText ISBN: | 9781118971130 |
| Edition: | 1 |
| Copyright: | 2018 |
| Format: | Reflowable |
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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)